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

Primary Purpose

Functional Abdominal Pain Syndrome, Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention group
Active control group
Sponsored by
University of Potsdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Abdominal Pain Syndrome focused on measuring Functional abdominal pain, psychological intervention, quality of life, Randomized controlled trial, children

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center, Pediatric Gastroenterology
  • Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
  • University Medical Center, Pediatric Gastroenterology
  • Catholic Children's Hospital Hamburg Wilhelmstift
  • St. Vincenz Hospital
  • University Medical Center, Pediatric Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Active control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Health-related quality of 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
The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).

Full Information

First Posted
October 28, 2013
Last Updated
January 15, 2018
Sponsor
University of Potsdam
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1. Study Identification

Unique Protocol Identification Number
NCT02030392
Brief Title
A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Acronym
Stop-FAP
Official Title
"Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2014 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Potsdam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Syndrome, Abdominal Pain
Keywords
Functional abdominal pain, psychological intervention, quality of life, Randomized controlled trial, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Active control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Stop the pain with Happy Pingu
Intervention Description
Cognitive-behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Active control group
Intervention Description
Education and information
Primary Outcome Measure Information:
Title
Change in Pain Symptoms
Description
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.
Time Frame
up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Secondary Outcome Measure Information:
Title
Pain-related impairment
Description
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).
Time Frame
up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Title
Health-related quality of life
Description
The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Time Frame
up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Title
Pain-related coping and cognitions
Description
The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Time Frame
up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Warschburger, Professor
Organizational Affiliation
University of Potsdam, Counselling Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center, Pediatric Gastroenterology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
City
Darmstadt
ZIP/Postal Code
64287
Country
Germany
Facility Name
University Medical Center, Pediatric Gastroenterology
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Catholic Children's Hospital Hamburg Wilhelmstift
City
Hamburg
ZIP/Postal Code
22149
Country
Germany
Facility Name
St. Vincenz Hospital
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
University Medical Center, Pediatric Gastroenterology
City
Ulm
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22328460
Citation
Gross M, Warschburger P. Evaluation of a cognitive-behavioral pain management program for children with chronic abdominal pain: a randomized controlled study. Int J Behav Med. 2013 Sep;20(3):434-43. doi: 10.1007/s12529-012-9228-3.
Results Reference
background
Citation
Groß, M. & Warschburger, P. (2013). Chronische Bauchschmerzen: Psychosoziale Belastung und behandlungsinduzierte Veränderungen in der Krankheitsbewältigung. Verhaltenstherapie, 23, 80-89. doi: 10.1159/000351215.
Results Reference
background
Citation
Warschburger, P. & Groß, M. (2008). "Stopp den Schmerz" - ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Verhaltenstherapie, 18, 162-167.
Results Reference
background
PubMed Identifier
25212457
Citation
Warschburger P, Calvano C, Becker S, Friedt M, Hudert C, Posovszky C, Schier M, Wegscheider K. Stop the pain: study protocol for a randomized-controlled trial. Trials. 2014 Sep 11;15:357. doi: 10.1186/1745-6215-15-357.
Results Reference
background
PubMed Identifier
33767111
Citation
Warschburger P, Calvano C, Becker S, Ebinger F, Hudert C, Iven E, Posovszky C, Winter SM, Daubmann A, Ozga AK, Wegscheider K. Do Children With Functional Abdominal Pain Benefit More From a Pain-Specific Cognitive-Behavioral Intervention Than From an Unspecific Attention Control Intervention? Results of a Randomized Controlled Trial. Am J Gastroenterol. 2021 Jun 1;116(6):1322-1335. doi: 10.14309/ajg.0000000000001191.
Results Reference
derived
Links:
URL
http://www.psych.uni-potsdam.de/counseling/index-e.html
Description
Homepage Counseling Psychology, Prof. Warschburger
URL
http://www.psych.uni-potsdam.de/counseling/research/fap-e.html
Description
Description of research project

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

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