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

January 15, 2018 updated by: Petra Warschburger, University of Potsdam

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • University Medical Center, Pediatric Gastroenterology
      • Darmstadt, Germany, 64287
        • Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
      • Düsseldorf, Germany, 40225
        • University Medical Center, Pediatric Gastroenterology
      • Hamburg, Germany, 22149
        • Catholic Children's Hospital Hamburg Wilhelmstift
      • Paderborn, Germany, 33098
        • St. Vincenz Hospital
      • Ulm, Germany, 89075
        • University Medical Center, Pediatric Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
Cognitive-behavioral intervention
Other Names:
  • Stop the pain with Happy Pingu
Active Comparator: Active control group
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
Education and information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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).
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
Time Frame: 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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Potsdam

Investigators

  • Principal Investigator: Petra Warschburger, Professor, University of Potsdam, Counselling Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2014

Primary Completion (Actual)

July 7, 2017

Study Completion (Actual)

July 7, 2017

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA1143/9-1
  • DRKS00005038 (Registry Identifier: DRKS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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