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

NCT ID: NCT02030392

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-07-07

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.

Conditions

Functional Abdominal Pain Syndrome; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: BEHAVIORAL

Cognitive-behavioral intervention

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).

Group Type: ACTIVE_COMPARATOR

Active control group

Intervention Type: BEHAVIORAL

Education and information

Interventions

Intervention group

Cognitive-behavioral intervention

Intervention Type: BEHAVIORAL

Active control group

Education and information

Intervention Type: BEHAVIORAL

Other Intervention Names

Stop the pain with Happy Pingu

Eligibility Criteria

Inclusion Criteria

• aged 7-12 years
• abdominal pain for at least 2 months
• abdominal pain at least once per week
• unclear cause for abdominal pain

• 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

• 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

• psychiatric disorder (internalizing) with primary treatment indication
• severe externalizing disorder

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Potsdam

OTHER

Sponsor Role: lead

Responsible Party

Petra Warschburger

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petra Warschburger, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Potsdam, Counselling Psychology

Locations

University Medical Center, Pediatric Gastroenterology

Berlin, , Germany

Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology

Darmstadt, , Germany

University Medical Center, Pediatric Gastroenterology

Düsseldorf, , Germany

Catholic Children's Hospital Hamburg Wilhelmstift

Hamburg, , Germany

St. Vincenz Hospital

Paderborn, , Germany

University Medical Center, Pediatric Gastroenterology

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22328460 (View on PubMed)

Groß, M. & Warschburger, P. (2013). Chronische Bauchschmerzen: Psychosoziale Belastung und behandlungsinduzierte Veränderungen in der Krankheitsbewältigung. Verhaltenstherapie, 23, 80-89. doi: 10.1159/000351215.

Reference Type: BACKGROUND

Warschburger, P. & Groß, M. (2008). "Stopp den Schmerz" - ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Verhaltenstherapie, 18, 162-167.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25212457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33767111 (View on PubMed)

Related Links

http://www.psych.uni-potsdam.de/counseling/index-e.html

Homepage Counseling Psychology, Prof. Warschburger

http://www.psych.uni-potsdam.de/counseling/research/fap-e.html

Description of research project

Other Identifiers

DRKS00005038

Identifier Type: REGISTRY

Identifier Source: secondary_id

WA1143/9-1

Identifier Type: -

Identifier Source: org_study_id