Overview

This trial is active, not recruiting.

Conditions functional abdominal pain syndrome, abdominal pain
Treatments intervention group, active control group
Sponsor University of Potsdam
Start date April 2014
End date April 2017
Trial size 127 participants
Trial identifier NCT02030392, DRKS00005038, WA1143/9-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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).
intervention group Stop the pain with Happy Pingu
Cognitive-behavioral intervention
(Active Comparator)
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).
active control group
Education and information

Primary Outcomes

Measure
Change in Pain Symptoms
time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

Secondary Outcomes

Measure
Health-related quality of life
time frame: 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
time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Pain-related self-efficacy
time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

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

Additional Information

Official title "Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Principal investigator Petra Warschburger, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Potsdam.