DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.

Study Overview
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Brief Summary
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Chronic and recurrent pain is a very important issue in the society, and its treatment is challenging. In children, one of the most common pain problems is recurrent abdominal pain. This problem can affect up to 12% of the children population, and can interfere on daily activities of both children and parents. Recurrent abdominal pain in children is also associated with other health problems, and can be related to problems in adulthood. Unfortunately, the current health system does not have an effective treatment for these children and their families. This is why the investigators propose an online intervention, DARWeb, for people in this situation. DARWeb provides an innovative solution using Information and Communication Technology to facilitate access. It is also innovative because it is directed towards secondary prevention, in contrast to the majority of current treatments available for pain problems that are focused in reducing the impact of pain when it is already severe. Thus, the objective of DARWeb is to provide information and teach strategies to children and their parents that help them to cope with pain and prevent pain interference in their daily lives (in the short, medium and long term). With this project, the investigators plan, first, to create a new version of their treatment program (DARWeb V2) from the results of the pilot study. Second, the investigators will test the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they will assess the short, medium and long term effects. In addition, the investigators want to study which of the variables that are addressed in their intervention are responsible for the potential changes observed. The investigators expect that their treatment program will be effective to reduce pain in the short, medium and long term.

Official Title
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DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.

Conditions
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Abdominal Pain

Intervention / Treatment
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* Behavioral: DARWeb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 9 to 15 years Recurrent abdominal pain (abdominal pain at least once at month during a period of three months) Low level of disability Exclusion Criteria: Identifiable organic cause. Disability preventing them to follow an online intervention. Not having a computer with Internet access. Not being able to read in Spanish language.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this arm will follow DARWeb: an online psychosocial intervention for children with recurrent abdominal pain and their parents. This is composed by 7 units for parents and 7 units for children, that have been developed from the cognitive-behavioral model, including setting goals, relaxation and distraction techniques, changing maladaptive thoughts and assertive communication training. The team under the program only contact with families for sending reminders and to answer potential technical problems or doubts | Behavioral: DARWeb<br>* Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.<br>|
| No Intervention: Control<br>Participants allocated in this arm will not receive intervention. However, they will be invited to participate once the families allocated to the experimental group complete the program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Assessed with the abdominal Pain Index | 2 weeks after intervention | 
| Pain Frequency | Assessed with the abdominal Pain Index | 2 weeks after intervention | 
| Pain Intensity | Assessed with the abdominal Pain Index | 6 months after the intervention | 
| Pain Intensity | Assessed with the abdominal Pain Index | 12 months after the intervention | 
| Pain Frequency | Assessed with the abdominal Pain Index | 6 months after the intervention | 
| Pain Frequency | Assessed with the abdominal Pain Index | 12 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Assessed with the Pediatric Quality of Life Inventory | 2 weeks after intervention; 6 and 12 months. | 
| Disability | Assessed with the Functional Disability Inventory | 2 weeks after intervention; 6 and 12 months. | 
| Depression | Assessed with the Children Depression Inventory. | 2 weeks after intervention; 6 and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online Intervention, Recurrent Abdominal Pain, Children