SPECIAL TOPICS SERIES

Testing the Feasibility of DARWeb An Online Intervention for Children With Functional Abdominal Pain and Their Parents Rube´n Nieto, PhD,* Eula`lia Herna´ndez, PhD,* Merce` Boixado´s, PhD,* Anna Huguet, PhD,wz Imma Beneitez, MclPsych,* and Patrick McGrath, PhDzy

Objectives: To test the feasibility of an online intervention (DARWeb) for children with functional abdominal pain and their families. Methods: An online intervention (with 7 units for children and 7 for parents) was developed from a cognitive-behavioral perspective. A total of 15 families were given access to the intervention and asked to rate their satisfaction with each unit and the overall program (using scales from 0 to 10). Moreover, they were interviewed at the end of the program to obtain more information about their impressions of the program. Results: Nine families (60%) completed the entire program. Parents rated each unit above a median of 8; children also rated all of the units except the first 2 above a median of 8. Global ratings were also very positive. Qualitative data reinforce the idea that the participants were quite satisfied with the intervention, they appreciated the fact that it was online, and they learned coping strategies (they were especially happy with relaxation) and to give less importance to pain. Although they appreciated the available resources, they would like to have more multimedia and interactive resources, and some form of professional contact. Parents also suggest that it was a burden (in terms of time) to supervise their children’s progress in the program. Discussion: DARWeb has been shown to be a feasible intervention, and it seems to be well designed. However, some improvements need to be considered based on the experiences of these participating families, and further research should be conducted to test its efficacy. Key Words: online intervention, functional abdominal pain, feasibility, satisfaction

(Clin J Pain 2015;31:493–503) Received for publication June 9, 2014; revised January 12, 2015; accepted December 8, 2014. From the *PSiNET Research Group, Internet Interdisciplinary Institute, Universitat Oberta de Catalunya, Barcelona, Spain; Departments of wCommunity Health and Epidemiology; yPsychiatry, Pediatrics, and Community Health & Epidemiology, Dalhousie University, Halifax; and zIWK Health Centre, Halifax, Nova Scotia, Canada. The authors acknowledge that some sections of DARWeb are based on myWHI (an Internet-based CBT intervention for youth with headaches, led by Drs McGrath and Huguet) and the Strongest Family Program (distance family interventions for youth, led by Drs McGrath and Lingley-Pottie). DARWeb project has been funded by a grant from the Fundacio´ La Caixa (Recercaixa, 2012-2013), Barcelona, Spain and the “Ministerio de Economı´ a y Competitivad” (Spanish Government, reference: PSI2013-42413-R; 2014-2016), Madrid, Spain. PSiNET is a research group that is recognized and supported by the Catalan Government (2014SGR858), Barcelona, Spain. The authors declare no conflict of interest. Reprints: Rube´n Nieto, PhD, Estudis de Psicologia i Cie`ncies de l’Educacio´, Universitat Oberta de Catalunya, Rambla Poblenou, 156, 08018 Barcelona, Spain (e-mail: [email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000199

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ecurrent abdominal pain (RAP) is one of the most common pain problems in children,1 with the best estimate of its prevalence in systematic reviews being around 12%.2 The traditional definition of RAP states that it involves the presence of at least 3 episodes of abdominal pain over the past 3 months that are severe enough to interfere with the child’s functioning.3 Currently, the term functional abdominal pain (FAP) is preferred to refer to children with abdominal pain in the absence of anatomic abnormality, inflammation, or tissue damage.4 FAP can negatively impact the quality of life of both children and their families,5,6 and it is often associated with other pain and mental health problems.7–11 It can also persist for years and be associated with other pain problems and psychological disorders in later life.4,12–14 Effective interventions could help to improve the quality of life of children with FAP and their families and reduce its consequences later in life. Previous literature shows that psychosocial interventions are effective for children with recurrent and chronic pain,15–17 and specifically for children with FAP.18–20 However, they are difficult to access for different interrelated reasons.21,22 First, there are very few multidisciplinary pain services for children with recurrent or chronic pain.23 Second, health care professionals receive very little training in pain assessment and management.23–26 Third, related specifically to FAP, there are diagnostic problems that make access to effective interventions difficult.7 Children usually undergo numerous time-consuming investigations to exclude organic causes,27 and meanwhile they may not be receiving adequate treatment. In addition, not all families consult a doctor about FAP.28 These nonconsulters maybe missing the opportunity to receive treatment that could prevent long-term problems. Apart from these difficulties in accessing effective interventions, it is also important to acknowledge that the standard medical care provided is usually focused on tertiary rehabilitation, that is, on providing care to patients who have long-lasting and debilitating problems. However, a shift in our medical care philosophy toward treating children earlier in the process, before significant disability is established, could reduce long-term suffering and the economic burden on the health care system.12 This perspective has traditionally been suggested in the literature on adults,29 but it is also increasingly highlighted in the literature on children.30 Online interventions are one way to overcome barriers to accessing effective psychological interventions.22,31 By increasing access, online interventions can help to advance in the area of secondary prevention.32 However, apart from being accessible, interventions have to be directed toward www.clinicalpain.com |

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reducing risk factors related to chronic pain and long-term disability,29,30 such as parents’ perceptions of their child’s pain or children’s catastrophic thoughts, among others.4,33–35 Moreover, these interventions should include the family, as they can have a strong influence on the child’s pain and on maintaining the effects of the intervention.36–38 Despite the great potential of online interventions for increasing access to effective interventions and advancing in the direction of secondary prevention, the literature on pediatric pain is still scarce.22 In the case of FAP, only 2 interventions have been tested in children with FAP (also including other pain problems in their samples).31,39 In one of them, Hicks et al31 found a greater proportion of children who achieved a clinically significant improvement in pain in the treatment group (1 and 3 mo after their 7-week online intervention). In the other, Palermo et al39 also found a greater proportion of children who achieved a clinically significant improvement in the treatment group and a greater reduction in activity limitations and pain intensity. Moreover, these positive changes were maintained at a 3-month follow-up, and scores on depressive symptoms and protectiveness also decreased. Although not online, the study by Wasson et al40 is also relevant, in which a 4-week program using a CD-ROM was delivered to children with functional gastrointestinal disorders (without a specific component for parents). They found a reduction in abdominal pain frequency and the use of passive coping strategies, and an increase in quality of life, in the children after the intervention. In this scenario, we have created DARWeb, an online psychosocial intervention for children with FAP and their parents. We want to contribute to advancing in this field by providing an accessible intervention designed specifically for children with FAP and their parents, and oriented toward the secondary prevention of long-term disability. We consider it important to create a specific intervention for FAP to provide participants with a more tailored intervention. In this line, various interventions for specific pediatric pain problems (most of them face-to-face interventions) have been developed and studied in the literature.15–17 Their rationale is that they make it possible to address topics and factors that can be relevant to a specific pain problem and not others, and develop learning contents tailored to the specific problem, such as addressing specific triggers related to FAP or providing examples of real situations of people living with FAP. In this way, participants will probably identify more with the contents and find them more meaningful and attractive. Moreover, to contribute to secondary prevention, DARWeb has been designed to address and teach participants how to cope with important risk factors for the development of long-term disability (eg, stress management, catastrophizing, and parental reinforcement behaviors) in the different units developed for parents and children. In addition, we have made an effort to consider its future accessibility, applicability, and cost. Along these lines, DARWeb is a self-guided intervention that does not require the figure of a coach or therapist interacting with participants. We think this aspect will facilitate the adoption of this intervention (after testing its efficacy) at the primary care level, before children have severe pain problems. However, we are aware that this decision will probably reduce the number of families who complete the program. It is also important to highlight that this study is part of a research path that begins with the study of

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pediatricians’ perceptions of an online intervention for FAP like DARWeb.41 Pediatricians believed that an online psychosocial intervention for FAP would be more effective in reducing pain intensity and disability and improving prevention than the standard medical care they were prescribing. They felt that an online intervention would be as effective as a face-to-face psychosocial intervention for children with mild levels of disability. The next step was to develop DARWeb and test its feasibility with a small sample, which is the focus of this study. The specific objectives are: (1) to assess the completion rate and time required to complete DARWeb; (2) to assess satisfaction with the entire intervention and with specific features, and gather information to improve its design and content. Although there is prior literature supporting engagement and user satisfaction with online interventions in children with chronic pain,42–44 no available studies evaluate these issues in an intervention with the characteristics of DARWeb. Moreover, this study focuses on obtaining and combining quantitative and qualitative data to approach families’ satisfaction and experiences with DARWeb. We hypothesize that between 60% and 70% of the sample will complete the intervention. This has been estimated taking into account that the completion rate for faceto-face psychosocial programs for children with FAP can be situated around 75%19; and rates between 77%39 and 93%31 have been found in available online interventions where children with FAP have been included. We propose a lower range because our intervention does not include a coach or therapist. In addition, we hypothesize that participants will report moderate to high ratings of satisfaction with the intervention, they will perceive it as helpful and meaningful for managing their situation, and they will make important suggestions to improve DARWeb.

METHODS A mixed-methods concurrent study design was used, combining qualitative and quantitative data with equal status45 to obtain complementary information from both strategies (QUAN + QUAL).

DARWeb: Psychosocial Intervention The online intervention has parallel contents for parents and children. The focus was on teaching parents and children coping strategies to reduce pain and disability from pain. The intervention includes 7 units for parents and 7 units for children. Table 1 shows the title of each unit and the main descriptors. Units were scheduled weekly, and it was estimated that it could take around 30 minutes to complete each unit; participants were encouraged to complete each unit on 1 or 2 different days. They had to complete 1 unit before they were allowed to start the next one. Parents and children were told to complete their units separately, although we encouraged parents to help their children and supervise their progress (motivating their child). Parents were given the option to follow DARWeb together (the father and the mother), or it could be done by only one of them. Units were composed of text, graphics, and multimedia. It is worth noting that we created a comic booklet to guide the children’s program. In this comic, the main character was a child with FAP, and the situations he was experiencing were used to introduce the main topics for each unit. Examples of the videos and materials can be seen

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Testing the Feasibility of DARWeb

TABLE 1. Outline of the Contents for Parents and Children

Unit

Parents

Children

1

Information about FAP What is FAP? Characteristics; Impact; Treatment

Information about FAP What is FAP? Characteristics; Impact; Treatment

2

Pain and Triggers Pain mechanisms; What are triggers? Triggers management; Problem solving

Pain and Triggers Pain mechanisms; What are triggers? Triggers management

3

Setting Goals What is a SMART goal?

Setting Goals What is a SMART goal?

4

Parents’ responses to child’s pain How parents’ responses affect FAP; strategies to promote the child’s well behaviors and reduce the child’s pain behaviors

Relaxation Progressive muscle relaxation and breathing

5

Communication Different communication styles; Training in assertive communication

Communication Different communication styles; Training in assertive communication

6

Parents’ responses to their own pain Importance of having positive role models

Thought management How negative thoughts can affect pain; Changing negative thoughts

7

Thought management How negative thoughts can affect pain; Changing negative thoughts

Distraction Pain and attention; Distraction techniques (attention focusing, imagination, and mental games)

at: http://psinet.uoc.edu/index.php/en/projects?id = 38. All these graphic materials were developed by specialized professionals working in different graphic and multimedia enterprises. DARWeb units are divided into 5 sections: objectives, introduction, training, exercises, and summary. The objectives section presents the main aims for the unit. Moreover, parents receive a brief explanation of the topic their child is going to work on during the week and a pdf file with the corresponding contents of the children’s unit. The introduction section provides a theoretical basis for the topic addressed, whereas the training section provides specific instructions about how to apply the skills taught in the unit. In the exercises section, some small tasks are proposed to further consolidate the skills taught. Finally, the summary section includes a short summary of the contents of the unit, and the system automatically sends an e-mail to the participants with a pdf file containing the contents. DARWeb was designed to be self-guided. The research staff only planned to contact participants during the program to send them reminders if they had not logged onto the program for 10 days. If the research staff considered it appropriate to send a reminder (on the basis of the specific interaction with the family), it was typically sent by e-mail; but families that did not reply in one week (after sending an e-mail reminder) were contacted by phone. DARWeb was implemented using the Intelligent Research and Intervention Software (IRIS) platform, developed at the IWK Health Center. This is a web-based application designed to be very flexible and accommodate different interventions. IRIS is very intuitive, making it possible to create, administer, monitor, and deliver online interventions easily. Working with workflows is a very useful feature of IRIS that helps to adapt contents to users and facilitates interaction. Taking advantage of the IRIS system, we developed different strategies to personalize contents and provide some interaction. One of the most noteworthy strategies was to ask participants some personal details (eg, name, Copyright

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age, hobbies) and use this information to adapt the content. We also introduced different multiple choice questions throughout the program and provided different feedback/ content depending on the option selected. Finally, it is also worth noting that workflows also allows us to establish the hierarchy and order in which we want users to interact with the content, as well as revealing or not revealing different pieces of content on the basis of participants’ responses.

Procedure The study was approved by the Ethics Committee of the Universitat Oberta de Catalunya. Participating families were recruited through different collaborating health care centers in Spain and advertisements on different web sites. Collaborating centers sent us the contact information for families who met the inclusion and exclusion criteria. When we received their data, we called them by phone to briefly introduce the main aims of the intervention, and we invited them to attend a more extensive interview. The same procedure was followed with the families who had read the advertisements and contacted us by phone or e-mail. Families were interviewed (face-to-face or by videoconference, lasting approximately 20 min) to inform them about the study’s purposes and procedure and DARWeb’s characteristics, and the inclusion and exclusion criteria were assessed. If they were eligible, the parents were asked to sign an informed consent for their participation and authorize their child to participate. Parents and children who agreed to participate were asked to separately answer an online survey (pretreatment online survey) to gather sociodemographic and pain-related information. This survey was implemented using the Limesurvey software, an open source application to create and manage surveys (http://www.limesurvey.org). Those who completed this survey were given access to the intervention. Two weeks after finalizing the program, parents and children were asked to complete a similar online survey (posttreatment online survey) separately to gather information about their overall perceptions of the program (see

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the Measures section). Families were also interviewed (faceto-face or by videoconference) using indepth semistructured interviews (children and parents were interviewed together) after they had completed the posttreatment online survey. Two of the research team members conducted the interviews, which lasted approximately 30 minutes and were audio recorded. Apart from the 2 online surveys and the interviews after finishing the program, we gathered information related to satisfaction and the time taken to complete each unit through some questions included in DARWeb (at the end of each unit).

Participants Following the inclusion criteria, children with FAP from 9 to 15 years old and their parents were invited to take part in this study. The inclusion criteria were the classic ones proposed by Apley and Naish,3 that is, children with abdominal pain with a minimum of 3 episodes during the past 3 months that interfered with their daily activities. These criteria were used instead of those proposed by the most recent ROME criteria (http://www.romecriteria.org), which require the presence of abdominal pain at least once a week. Therefore, using Apley criteria gives us the opportunity to include children with less frequent abdominal pain problems who would otherwise be excluded. Children with an organic cause for their abdominal pain or with a severe mental illness were excluded. These criteria were assessed by the pediatrician referring them or confirmed by the participants during the initial interview with the research team. A total of 18 families were individually interviewed and invited to participate in our study. Three families did not complete the preintervention online survey and were not given access to the intervention (see the Procedure section). They told us that in the end they did not participate in the program due to lack of time or because the pain problem was not frequent or did not interfere much (2 families); the other family had family problems that kept them from participating. Therefore, there was a final sample of 15 families that at least had access to the intervention. Of them, 9 families completed all of DARWeb (see the Results section for more details).

Measures In this section, we present the different domains assessed through the 2 online surveys (preintervention and postintervention surveys), the questions included in DARWeb, and the semistructured interviews after finishing the program.

Sample Characteristics Sociodemographic information (age and sex), painrelated information, and quality of life data were gathered with the preintervention online surveys. The following painrelated information was collected: duration of abdominal pain (reported by parents), frequency of abdominal pain in the past 2 weeks (reported by children), and intensity of the most usual abdominal pain in the past 2 weeks (reported by children). Duration was assessed using a categorical question with the following 3 options: more than 1 year, between 6 and 12 months, or between 3 and 6 months. Frequency was assessed with a categorical question with the following 6 options: not at all, 1 or 2 days, 3 or 4 days, 5 or 6 days, more than 6 days, or every day. Usual intensity was

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assessed with an 11-point numerical scale, with the endpoints being 0, no pain and 10, the most pain possible. We assessed the quality of life with a short version of the Pediatric Quality of Life Inventory, which was validated in the Catalan population.46 This instrument is recommended to assess the impact of pain.47 Therefore, we decided to include it as a descriptive measure to better define the profile of the children in our program. With this instrument, children are asked how much of a problem each item has been in the past month. Items are scored on a 5-point Likert scale, from 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and linearly transformed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), and a total score can be computed by averaging all the items.

Completion Rate and Time Needed to Complete the Intervention We assessed how many families completed the intervention, how many weeks it took for them to complete the full intervention, and how long it took them to complete each unit. We did this in 2 different ways. On the one hand, we asked them to report how long it took them to complete the unit in minutes (with a question included at the end of each unit). On the other hand, we also obtained the time that each participant spent on each unit from the system’s records. We wanted to gather information from these 2 different sources, as both of them present limitations. Selfreported time can be very biased, as it depends on personal time perception, and it can also be influenced by social desirability. The time recorded through the system can also be biased as a result of inactivity. The system asked the user if he/she wanted to continue to be connected on a pop up after 15 minutes of inactivity. Therefore, some users could have been doing the units and taking short breaks (lasting 1y Between 6 and 12 mo Between 3 and 6 mo Pain frequency (%) Never 1 or 2 d 3 or 4 d 5 or 6 d More than 6 d Every day Usual pain intensity 5 (median [range]) PDSQL scores 79.17 (median [range])

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Not Completed DARWeb (n = 6)

88.89 11.11

83.33 16.67

0

0

33.33 44.44 11.11 11.11 0 0 (0-10)

0 33.33 16.67 33.33 16.67 0 6.50 (4-9)

(60.42-95.83)

76.04 (47.92-85.42)

PDSQL indicates Pediatric Quality of Life Inventory.

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TABLE 3. Time Spent on Each Unit

Self-reported (Median [Range]) Children Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Unit 7 Total program

30 45 30 60 35 45 58.65 310

(20-35) (10-90) (10-60) (10-60) (10-70) (20-120) (20-100) (110-420)

System (Median [Range])

Parents 30 35 30 35 40 30 45 230

Children

(15-45) (20-60) (20-60) (20-60) (20-60) (20-60) (20-60) (165-340)

33.23 36 30.37 52.77 40.52 44.02 52.82 349.33

(23.98-72.77) (8.57-63.68) (6.62-76.9) (5.47-126.87) (5.33-67.75) (7.58-84.17) (10.92-95.25) (68.47-407.97)

Parents 43.82 43.03 43.10 38.48 36.85 27.65 52.20 263.82

(14.57-100.67) (14.65-106.3) (9.63-61.62) (18.90-73.18) (22.23-81.08) (8.87-44.5) (8.78-98.57) (97.63-558.25)

All data are in minutes.

(children required more time). However, apart from these descriptive appreciations, there were no significant differences when comparing time spent on each unit or on the whole program by children and parents (both self-reported and system-reported time).

Satisfaction With the Different Elements and the Whole DARWeb Median ratings for each of the 7 DARWeb units (considering the 9 families who completed the full program) were very high for parents (above 8 for all units and for the 5 different aspects assessed: usefulness, interest, design, learning, and satisfaction). In the case of children, they were also high in general. However, the ratings of usefulness (median 6), interest (median 5), and design (median 7) for the first unit were moderate, and the ratings of the interest and design of the second unit were also moderate (6 for both ratings). All the other ratings were above 8. When ratings made by parents and children were compared, there were significant differences only on the following (parents’ ratings were higher): usefulness of unit 1 (Mann-Whitney U test: 18.50; P = 0.04); interest of unit 1 (Mann-Whitney U test: 17.5; P = 0.04); and design of unit 2 (Mann-Whitney U test: 18.5; P = 0.05). Figure 1 presents overall median ratings assessed at the end of the program (considering the 9 families who completed the full program). As the figure shows, all of them were quite high (Z9), suggesting that both parents and children were quite satisfied with the program as a whole, considering that the program helped them to cope with pain, and felt that their overall situation had improved. There were no significant differences on any of the 3 global ratings given by parents and children. Moreover, parents were pretty sure that DARWeb had helped their children to learn effective coping strategies (median 10).

Subjective Perceptions About the Different Elements and the Whole DARWeb Next, we present the main findings derived from the interviews. Findings are grouped into the 5 main topics discussed with the families, and we highlight here the most salient codes (See Table 4 to find all the codes indentified and the percentage of families that mentioned each of them).

Satisfaction With DARWeb All the families stated that they were generally satisfied with DARWeb, without referring to a specific content, part,

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or functionality of DARWeb (Generally satisfied with DARWeb code). They used statements like: [A mother] Honestly, it is very interesting, because it is focused on this problem, buty it is a very broad concept that you can absolutely apply to any life situation [P6: Generally satisfied with DARWeb]. All the families (100%) would also recommend DARWeb to other people affected by FAP (Recommend DARWeb code), as can be seen in statements such as: [A mother] To me, the truth is thatyI think you learn a lot with this; it is totally recommendable.” [P9: Recommending DARWeb]. Most of the families (89%) also highlighted, as a positive aspect, that DARWeb was very useful for them (DARWeb is useful code), as can be seen in the next example: [A mother] As I told you before, I think that DARWeb has taught me a lot of things, but the main thing is that, to clearly know what she had and that the solution is not so complicated.” [P9: DARWeb is useful]. Likewise, most of the families (78%) also suggested that they were quite happy with the comic and vignettes developed for the program (Comic’s vignettes and pictures code), with statements such as: [A child] The comic’s vignettes (are what I like the most) [P2: Comic’s vignettes and pictures]. “Negative aspects” of DARWeb, these were mentioned less frequently than the “positive codes.” The 3 most commonly mentioned codes were (with a frequency of 33%): Difficult to understand (referring to the contents); Comic’s vignettes and pictures; Too much reading. It is interesting to highlight that the families found both positive and negative aspects of the vignettes and pictures created for DARWeb.

Ideas for Improving DARWeb In total, 56% of the families stated that it would be useful for them to have more exercises or games (Adding exercises or games code), and to have forums to be able to contact professionals and other families (Adding forums code). An example was: [A mother] You can learn things from other families. Because maybe I didn’t notice one solution, and another

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TABLE 4. Codes Interpreted as a Result of Content Analysis of Indepth Interviews

n (%)* Positive aspects

Negative aspects FIGURE 1. Median for overall ratings after finishing the program. The line inside each box in the graphic represents the median value (percentile 50). The upper box limit represents quartile 75, and the lower limit represents quartile 25. Upper and lower whiskers represent scores outside the middle 50%. Finally, outliers are presented outside each box with asterisks.

9 9 8 7 6 6 4 4 3 2 2 1 3 3 3 2 2 2 1 1

(100) (100) (89) (78) (67) (67) (44) (44) (33) (22) (22) (11) (33) (33) (33) (22) (22) (22) (11) (11)

Satisfaction With DARWeb Generally satisfied with DARWeb Recommend DARWeb DARWeb is useful Comic’s vignettes and pictures Comic’s stories Videos Would participate again Relaxation techniques Reiterating main ideas Feeling reflected Reassurance of positive behaviors Setting SMART goals Difficult to understand Comic’s vignettes and pictures Too much reading Not feeling reflected Not users’ first language Boring and repetitive DARWeb is not useful Setting SMART goals

n (%)*

mother did (y) It would not be a bad idea to include a forum (y) [P8: Adding forums].

5 5 4 4 2 1

The other aspects highlighted were related to the following codes: adding more videos, adding face-to-face sessions, reducing units’ lengths, and reducing text).

Adding exercises or games Adding forums Adding videos Adding face-to-face sessions Reducing units’ lengths Reducing text for children

n (%)*

Burden A total of 56% of the families commented that the time required to complete each unit was established correctly (Time established correctly code). An example was: [A mother] (y) is looking for a little bit of time, if possible. The time (required) was correct from my point of view [P9 Time established correctly]. In contrast, 78% of the families mentioned (as a negative aspect) that it required a lot of time to oversee that the children were following the program correctly (Time supervision code): [A mother] “ (y) I tell him: ‘Hey, you have to do the DARWeb tasksy’” [P3: Time supervision].

Pain Perception and skills Hundred percent of the families said that they used relaxation techniques (Relaxation techniques code); for example, 1 participant explains: [A child] What I have used is relaxation, but apart from abdominal pain, for other things, for exams, problems with people. It was useful for me [P6: Relaxation techniques]. A total of 78% of the families mentioned that DARWeb changed their pain perceptions because it helped them to give less importance to pain (Giving less importance to pain code). A participant said that: [A mother] “The truth is that it helped us a lot also because, basically to meyit allowed me to not worry so much. I am not a suffering mother, but I am more relaxedy Because I said: she has a stomach ache, it doesn’t’ matter, it will go away” [P4: Giving less importance to pain]. Copyright

(56) (56) (44) (44) (22) (11)

Ideas for improving DARWeb

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Positive aspects Negative aspects

Burden

5 (56)

Time established correctly

7 (78) 2 (22)

Time supervision Lack of time

n (%)* Positive aspects

Negative aspects

9 7 6 5 5 2 1

(100) (78) (67) (56) (56) (22) (11)

n (%)* Positive aspects Negative aspects

8 7 7 5

(89) (78) (78) (56)

Pain perception and skills Relaxation techniques Giving less importance to pain Coping strategies Distraction techniques Pain reduction Communication techniques No pain reduction General perceptions about online interventions Advantages of technology Flexibility and comfort Online method satisfaction Technology problems

*Number of families and %.

In addition, 67% of the families mentioned (Coping strategies code) that they used coping strategies, and that they had learned to cope with pain (without referring to a specific skill). An example was: [A mother] (y) He has learned to cope with pain, which is one of the issues (y) Sometimes he has discomfort but in

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spite of it he does (his usual activities) (y) [P7: Coping Strategies].

General Perceptions About Online Interventions Finally, general perceptions about online interventions were quite positive. A total of 89% of families reported that using technology was an advantage for them (Advantages of Technology code). This code refers to suggestions made by families related to the fact that using technology and technical devices to follow DARWeb (or other interventions in general) is easy, nice, and comfortable. An example was: [A mother] (y) no problem; it is easy. I did the last four units using a Tablet, and it was perfect, no problem (y) [P6: Advantages of Technology]. Furthermore, 78% of the families highlighted advantages related to the flexibility and comfort of online interventions (Flexibility and comfort code): [A mother] You do it at the time that you can and in your home, at your paceythis is a big advantage. Especially when you have 3 daughters and every evening you have activities after school” [P9: Flexibility and comfort]. Finally, 78% expressed general satisfaction with the online delivery method (Online method satisfaction code). This category includes comments by families in which they specifically mentioned that they were happy with the fact that the intervention was online. [A mother] (y) I like online, definitely! [P7: Online method satisfaction]. In contrast, 56% of the families reported having had some technical problems (Technology problems code): [A mother] In the tablet directlyy Some videos don’t work (y) [P7: Technology problems].

Noncompleters’ Experience on DARWeb. Of the 6 families who did not complete the program, 5 completed some of the DARWeb units, and 1 family did not complete any of them. Of the 5 families who completed some units, they completed the following numbers of units: Family 1: the child completed the first 3 units and the mother the first 2; Family 2: the child completed the first 2 units, and the parents did not complete any of them; Family 3: both the child and the mother completed the first 3 units; Family 4: the mother completed the first 2 units, and the child did not complete any of them; Family 5: the mother completed the first 3 units, and the child the first 2. The 6 families who did not complete the program were contacted by e-mail and phone to remind them (as specified in the study procedure), until they told us they did not want to continue with the program (5 families), or they did not answer our contacts (1 family did not reply to our phone calls and/or e-mails). These families received a median of 2 e-mail reminders (range, 1 to 4), being the specific frequencies as follows: 33.33% families received 1 e-mail; 50.00% received 2 e-mails; and 16.67 received 4 e-mails. The median number of phone call reminders was 2 (range, 1 to 3), and frequencies: 33.33% families received 1 phone call; 50.00% received 2 phone calls; and 16.67 received 3 phone calls. Finally, reasons reported for not being willing to follow the program were: (1) not having enough time to follow DARWeb (n = 4); (2) not having a severe enough

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problem (n = 2); and having another problem that needed more attention than FAP (n = 1). Median self-reported time (expressed in minutes) for completing each specific unit was as follows (bold numbers refer to parents’ data): 30/37.50 for unit 1; 37.50/30 for unit 2; and 22.50/35 for unit 3. Similar descriptives were found for the median system-reported time (bold numbers refer to parents’ data): 48.47/44.73 for unit 1; 37.37/30.52 for unit 2; and 21.88/30.05 for unit 3. In relation to satisfaction, at the end of the units we collected the 5 ratings described in the measures section. However, due to space limitations, we present here only the median for the ratings of general satisfaction with each unit. These were (in bold for parents): 8.50/8.50 for unit 1; 8.50/9 for unit 2; 9/7 for unit 3.

DISCUSSION This study was designed to assess the feasibility of DARWeb, an online intervention for children with FAP and their parents. The DARWeb completion rate was acceptable, and satisfaction with the program was high for both parents and children. Families highlighted some important points related to the intervention design in the semistructured interviews. We discuss all the results below, integrating both quantitative and qualitative data, and relating them to the available literature. The DARWeb completion rate was a basic measure in our study to assess feasibility and acceptability. In our study, 60% of families completed the whole program, with this result being inferior to what was found in previous online interventions that included children with FAP.31,39,42 We consider this result acceptable, taking into account the hypotheses presented in the introduction. However, we think there is still room to improve this rate. For this reason, next we discuss the most important factors affecting this measure, and what could be done in the future development of DARWeb. The first and probably most relevant factor is the inclusion of a coach or therapist. Both previous online intervention studies that included children with FAP31,39,42 had a professional who periodically contacted the families to follow their progress, solve problems, give feedback, and/or review the assignments. Although including a figure like this is common in Internet interventions for youth, and it can be beneficial for improving outcomes and the rate of completion,42,49 we decided not to include one because we wanted to reduce the economic cost of DARWeb as much as possible. However, we probably need to think carefully about this issue in the future development of our intervention, and include some form of personal contact because, apart from the data available in the literature, participants in this study were concerned about this. Nearly half of the participating families suggested that they would appreciate having some type of faceto-face sessions, and more than half of the families also suggested the idea of adding forums (for contact with professionals and/or peers). This latter idea of including online forums in DARWeb could be an intermediate step between having a coach or therapist and having no contact. It could help to increase the completion rate and be positive for the families, while at the same time being less expensive than having a “full-time” coach or therapist.” Previous literature supports its use, suggesting that families can benefit from the similarity of other families’ experiences and obtain support, and they can also benefit from the

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professional support provided by forums.50,51 Thus, in the future development of DARWeb, we will consider including a forum for questions addressed to a professional, available for a limited time (eg, once a week), and a forum for communication among peers. A second contributing factor could be DARWeb’s design and features. The intervention for parents in DARWeb was longer than in the program by Hicks et al31 (they only had to complete 2 units, whereas in our program we asked them to complete 7 units). However, the effort for parents in our study was quite similar to the study by Palermo et al,39 in terms of time to complete the units and the number of units, which coincides with the similar rate of completion we found for parents. Apart from the length of the intervention, there are other differences in the way the programs were designed that can affect their attractiveness. For example, the program by Palermo et al39 presented a story that was very attractive to the participating children. They made the theme for each session a different country, and children “had to play” and complete the unit to obtain each country’s passport. We used a comic as a potentially appealing way to introduce the main concepts and their applicability to the child’s daily life, and we also used videos to reduce the amount of written text and transmit the knowledge in the most educational way possible. Families were quite happy with these resources, but in the further development of DARWeb we will study how to include more “gamification” and more interactive elements (in addition to reducing the length of the units). This was suggested as a potential improvement by more than half of the families, and it is also suggested in the literature as an important element.52,53 Third, the participants’ age can also help to explain the differences in the completion rate. Specifically, the participating children in the study by Palermo et al39 were older than those in our sample (mean age, 14.3; range, 9 to 16 y). In the study by Hicks et al,31 the children were also slightly older (mean age, 12.1; range, 9 to 16 y) than in our study (median age, 11; range, 9 to 14 y). The older children in these previous studies may have been more autonomous in following their program, and able to do it more easily than the children in our sample. Most of the participating parents mentioned that they had to make a big effort to make sure that the children completed the program. Older children would probably require less supervision. However, related to this issue, we will maintain this age group in future developments of DARWeb to allow as many families as possible to follow the intervention. But, in line with the program design, it is our intention to introduce elements in the intervention that allow participants to personalize the contents based on their age. Finally, it is important to highlight that those families who did not complete the whole intervention seem to have had similar experiences (ie, reported similar satisfaction ratings and needed a similar amount of time to complete each unit) to those who completed the whole program. They mentioned not having enough time as a main reason for not finishing the program. This is an inherent characteristic of online interventions, as they require participants to organize their personal time, and this can be more difficult than attending a face-to-face intervention with a predefined schedule (eg, twice a week).54 In the future development of DARWeb, we will take this into account, and we will emphasize issues related to time management at the beginning of the program. Copyright

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Furthermore, in accordance with previous available literature,43,44 it is important that both parents and children were highly satisfied with each unit and with DARWeb overall. More specifically, they rated each unit as useful, interesting and well designed. They would also recommend DARWeb to other families and considered that DARWeb had improved their situation. Furthermore, the parents felt that their children had learned important skills for coping with pain. Moreover, although half of the families had technical problems, the vast majority of the participants felt satisfied with the use of technology and the Internet as a way to access the program. They highlighted the advantages that are usually suggested in the literature, such as accessibility, flexibility, and comfort.51,55 Apart from being satisfied, it is important to note that they felt that the program had helped them to learn skills and changed their pain perceptions. Along these lines, all the families were happy with the relaxation techniques, and most of them reported that they had learned to give less importance to pain. Moreover, as a transversal theme, parents and children usually said they would apply what they had learned in DARWeb to future situations, and not only those related to pain. This means that the program provides families with useful and transferable tools to improve their quality of life, as patients usually claim when following online interventions or turning to the Internet for health resources.56 This study has several limitations. One of the most important is the sample size. We purposely selected a small sample because this was a preliminary trial, and conducting the assessments and interviews was very time consuming. However, the results would be more robust with a larger sample. A second limitation is that data collected through our surveys, and, in particular, through the interviews, could have been affected by social desirability bias. Finally, this intervention, as occurs with Internet-based interventions, is not likely to be available to families with lower socioeconomic levels, as they do not have easy access to technology. However, the number of families with access to the Internet is increasing, and mobile devices with Internet connection play an important role, as they are becoming very popular.57,58 We decided to first create DARWeb for computers (although it can also be accessed using tablets) because it has written contents that might be hard to read on a small mobile device. However, as a potential way to increase access to DARWeb, this is an issue we should address in the future. Another alternative would be to offer access to the intervention through health care centers or other services available to the community (such as libraries or children’s schools), so that families would not need to have Internet at home. However, this option would remove some of the advantages of online interventions (eg, flexibility, comfort). In conclusion, taking into account the results of this study and the main characteristics of DARWeb (ie, specific for children with FAP, directed to risk factors, and selfguided), we consider that the presented intervention could be a good alternative (if it proves to be effective) to offer at the primary care level for children with FAP and their families. This could be a first step in a stepped-care approach29 directed toward preventing long-term problems. That is, DARWeb could easily be offered to all families with children with nonsevere pain problems, and additional resources (and more intensive interventions) should be offered to children at higher risk of having long-term

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problems. This conclusion agrees with the results of our previous study41 showing that pediatricians would be likely to recommend a resource of this type, and that they consider it more effective for children with mild or moderate levels of disability. ACKNOWLEDGMENTS The authors thank the individual professionals and collaborating centers that facilitated contact with participating families and helped us with the project. They include: Consorci d’Atencio´ Primaria de Salut de l’Eixample (CAPSE); Hospital Verge de la Cinta de Tortosa; Hospital de nens de Barcelona; CAP Sant Vicenc¸ de Castellet; Equip Territorial de Pediatria Alt Penede`s; Hospital Universitari Sant Joan de Reus; ABS Girona 3. They are also very grateful to the families who participated in this study. REFERENCES 1. Chitkara DK, Rawat DJ, Talley NJ. The epidemiology of childhood recurrent abdominal pain in western countries: a systematic review. Am J Gastroenterol. 2005;100:1868–1875. 2. King S, Chambers CT, Huguet A, et al. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011;152:2729–2738. 3. Apley J, Naish N. Recurrent abdominal pains: a field survey of 1000 school children. Arch Dis Child. 1958;46:165–170. 4. Levy RL, van Tilburg MA. Functional abdominal pain in childhood: background studies and recent research trends. Pain Res Manage. 2012;17:413–418. 5. Oostenbrink R, Jongman H, Landgraf JM, et al. Functional abdominal complaints in pre-school children: parental reports of health-related quality of life. Qual Life Res. 2010;19: 363–369. 6. Yousseff NN, Rosh JR, Loughran M, et al. Treatment of functional abdominal pain in childhood with cognitive behavioral strategies. J Pediatr Gastroenterol Nutr. 2004;39: 192–196. 7. Brett T, Rowland M, Drumm B. An approach to functional abdominal pain in children and adolescents. Br J Gen Pract. 2012;62:386–387. 8. Campo JV, Bridge J, Ehmann M, et al. Recurrent abdominal pain, anxiety, and depression in primary care. Pediatrics. 2004;113:817–824. 9. Dufton LM, Dunn MJ, Compas BE. Anxiety and somatic complaints in children with recurrent abdominal pain and anxiety disorders. J Pediatr Psychol. 2008;34: 176–186. 10. Garber J, Zeman J, Walker LS. Recurrent abdominal pain in children: psychiatric diagnoses and parental psychopathology. J Am Acad Child Adolesc Psychiatry. 1990;29:648–656. 11. Størdal K, Nygaard EA, Bentsen BS. Recurrent abdominal pain: a five-year follow-up study. Acta Paediatr. 2005;94: 234–236. 12. Dengler-Crish CM, Horst SN, Walker LS. Somatic complaints in childhood functional abdominal pain are associated with functional gastrointestinal disorders in adolescence and adulthood. J Pediatr Gastroenterol Nutr. 2011;52: 162–165. 13. Gieteling MJ, Bierma-Zeinstra SMA, Passchier J, et al. Prognosis of chronic or recurrent abdominal pain in children. J Pediatr Gastroenterol Nutr. 2008;47:316–326. 14. Walker LS, Dengler-Crish CM, Rippel S, et al. Functional abdominal pain in childhood and adolescence increases risk for chronic pain in adulthood. Pain. 2010;150:568–572. 15. Eccleston C, Palermo TM, Williams AC, et al. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014;CD003968.

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