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

University of Potsdam

Status: Completed

Conditions: Functional Abdominal Pain Syndrome; Abdominal Pain

Treatments: Behavioral: Intervention group; Behavioral: Active control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02030392

DRKS00005038 (Registry Identifier)

WA1143/9-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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127 participants in 2 patient groups

Intervention group

Experimental group

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).

Treatment:

Behavioral: Intervention group

Active control group

Active Comparator group

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).

Treatment:

Behavioral: Active control group