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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of Potsdam
Sponsor:
Information provided by (Responsible Party):
Petra Warschburger, University of Potsdam
ClinicalTrials.gov Identifier:
NCT02030392
First received: October 28, 2013
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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 Intervention
Functional Abdominal Pain Syndrome
Abdominal Pain
Behavioral: Intervention group
Behavioral: Active control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: "Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain

Resource links provided by NLM:


Further study details as provided by University of Potsdam:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up). A detailed description of measures will be added in the course of preparation phase.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Parental pain-related behavior [ Time Frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030392

Contacts
Contact: Petra Warschburger, Professor 0049-331-977-2988 warschb@uni-potsdam.de
Contact: Claudia Calvano, Diploma 0049-331-977-2825 calvano@uni-potsdam.de

Locations
Germany
University Medical Center, Pediatric Gastroenterology Recruiting
Berlin, Germany, 13353
Contact: Sybille Winter, PD Dr.    0049-30-450-566253    sybille.winter@charite.de   
Sub-Investigator: Sybille Winter, PD Dr.         
Sub-Investigator: Christian Hudert, Doctor         
Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology Recruiting
Darmstadt, Germany, 64287
Contact: Sebastian Becker, Doctor    0049-6151-402-3020    sebastian.becker@alice-hospital.de   
Sub-Investigator: Sebastian Becker, Doctor         
University Medical Center, Pediatric Gastroenterology Active, not recruiting
Düsseldorf, Germany, 40225
Catholic Children's Hospital Hamburg Wilhelmstift Recruiting
Hamburg, Germany, 22149
Contact: Enno Iven    0049-40 673 770    e.iven@wilhelmstift.de   
Contact: Henning Lenhartz, Doctor    0049-40-67377-400    h.lenhartz@wilhelmstift.de   
Principal Investigator: Henning Lenhartz, Doctor         
Principal Investigator: Enno Iven         
St. Vincenz Hospital Not yet recruiting
Paderborn, Germany, 33098
Contact: Friedrich Ebinger, PD    05251 86-40    f.ebinger@vincenz.de   
Contact: Thomas Lehmler, Dr    +49-5251-86-4213    tlehmler@vincenz.de   
University Medical Center, Pediatric Gastroenterology Recruiting
Ulm, Germany, 89075
Contact: Carsten Posovszky, Doctor    0049-731-500-57315    carsten.posovszky@uniklinik-ulm.de   
Sub-Investigator: Carsten Posovszky, Doctor         
Sponsors and Collaborators
University of Potsdam
Investigators
Principal Investigator: Petra Warschburger, Professor University of Potsdam, Counselling Psychology
  More Information

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
Study First Received: October 28, 2013
Last Updated: May 13, 2015
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 07, 2015