A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain (Stop-FAP)
Functional Abdominal Pain Syndrome, Abdominal Pain
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
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
Experimental
Active Comparator
Intervention group
Active control 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).
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).