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

Not Applicable

Completed

• Conditions: Abdominal Pain; Functional Abdominal Pain Syndrome

• Registration Number: NCT02030392
• Lead Sponsor: University of Potsdam

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Study Start: 2014-03-31
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-15
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Symptoms	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Pain-related impairment	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up	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).
Pain-related coping and cognitions	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up	The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Health-related quality of life	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up	The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).

Trial Locations

Locations (4)

University Medical Center, Pediatric Gastroenterology; 🇩🇪 Ulm, Germany

Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology; 🇩🇪 Darmstadt, Germany

Catholic Children's Hospital Hamburg Wilhelmstift; 🇩🇪 Hamburg, Germany

St. Vincenz Hospital; 🇩🇪 Paderborn, Germany