A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain

Study Overview
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Brief Summary
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This trial aims to compare two training programs for children suffering functional abdominal pain. These two programs are comparable in number of sessions and group sizes, but show differences in content (very focused on pain management vs. more general information and support). Focus of the trial is the evaluation of Stop the pain, which has shown high effectiveness in one first trial. This time, five clinics, experienced in diagnosis and treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are eligible. The programs imply six weekly group sessions for the children and 2 parent evenings. The study group assumes that participation in Stop the pain will reduce pain experience and will improve the children's quality of life and coping strategies - up to 12 months after training.

Detailed Description
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The trial aims to assess the efficacy of a cognitive-behavioral self-management program (intervention group, IG) compared to an equally extensive information-only control group (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral, manualized program Stop the pain with Happy Pingu. Follow up per patient: 3- and 12 months. Children aged 7-12 years suffering functional abdominal pain (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is that for patients in the IG the frequency and intensity of pain will be reduced more successfully and more sustainable than for children in the CG. Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG.

Official Title
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Stop the Pain-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain

Conditions
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Functional Abdominal Pain Syndrome, Abdominal Pain

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Active control group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for medical screening: aged 7-12 years abdominal pain for at least 2 months abdominal pain at least once per week unclear cause for abdominal pain exclusion criteria for medical screening: very limited German language skills mental retardation adjuvant psychological treatment at point of medical screening participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening at point of medical screening: therapy or medication for abdominal pain presentation of sibling aged 7-12 years Inclusion Criteria for study participation: pain-predominant functional gastrointestinal disorders according to Rome-III criteria (H2a, H2b, H2d, H2d1) informed consent for study particiaption informed consent for audiotaping of trainings sessions no time constraints for participation in training groups Exclusion Criteria for study participation: psychiatric disorder (internalizing) with primary treatment indication severe externalizing disorder

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>IG participation in the cognitive-behavioral program Stop the pain with Happy Pingu. The program compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each). | Behavioral: Intervention group<br>* Cognitive-behavioral intervention<br>* Other names: Stop the pain with Happy Pingu;|
| Active Comparator: Active control group<br>CG participation in an information and education control group (physical well-being, health and gastrointestinal tract). The program of the control group compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each). | Behavioral: Active control group<br>* Education and information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Symptoms | Primary efficacy endpoint is the frequency and intensity of pain (composite score) over the course of treatment and follow-up (pre, post, 3 and 12 months follow-up). This primary outcome will be assessed by pain diary in children's self-report (over 2 weeks).Statistically, the primary endpoint of the study is defined as the change of the logarithm of the area under the pain-intensity curve over one week from start of treatment to 12 month follow-up. The area under the pain intensity curve (auc) is a measure that reflects pain intensity as well as pain duration and pain frequency and thus can be understood as a composite measure of pain. | up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-related impairment | A measure for child's functional disability due to pain. The measure is one scale score and covers the level of impairment in everyday activitites due to abdominal pain by 12 items, e.g. reading, meeting friends, family life. The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up). | up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up | 
| Health-related quality of life | The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up). | up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up | 
| Pain-related coping and cognitions | The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up). | up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional abdominal pain, psychological intervention, quality of life, Randomized controlled trial, children