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

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ClinicalTrials.gov Identifier: NCT02030392
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Petra Warschburger, 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.

Condition or disease Intervention/treatment Phase
Functional Abdominal Pain Syndrome Abdominal Pain Behavioral: Intervention group Behavioral: Active control group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Actual Study Start Date : March 31, 2014
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030392


Locations
Germany
University Medical Center, Pediatric Gastroenterology
Berlin, Germany, 13353
Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
Darmstadt, Germany, 64287
University Medical Center, Pediatric Gastroenterology
Düsseldorf, Germany, 40225
Catholic Children's Hospital Hamburg Wilhelmstift
Hamburg, Germany, 22149
St. Vincenz Hospital
Paderborn, Germany, 33098
University Medical Center, Pediatric Gastroenterology
Ulm, Germany, 89075
Sponsors and Collaborators
University of Potsdam
Investigators
Principal Investigator: Petra Warschburger, Professor University of Potsdam, Counselling Psychology

Additional Information:
Publications:
Groß, M. & Warschburger, P. (2013). Chronische Bauchschmerzen: Psychosoziale Belastung und behandlungsinduzierte Veränderungen in der Krankheitsbewältigung. Verhaltenstherapie, 23, 80-89. doi: 10.1159/000351215.
Warschburger, P. & Groß, M. (2008). "Stopp den Schmerz" - ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Verhaltenstherapie, 18, 162-167.

Responsible Party: Petra Warschburger, Prof. Dr., University of Potsdam
ClinicalTrials.gov Identifier: NCT02030392     History of Changes
Other Study ID Numbers: WA1143/9-1
DRKS00005038 ( Registry Identifier: DRKS )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Petra Warschburger, University of Potsdam:
Functional abdominal pain
psychological intervention
quality of life
Randomized controlled trial
children

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive