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“Stop the pain – A multicenter, randomized-controlled study of a cognitive-behavioral intervention for children with functional abdominal pain“

“Stop the pain – A multicenter, randomized-controlled study of a cognitive-behavioral intervention for children with functional abdominal pain“ - Stop-FAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005038
Enrollment
112
Registered
2013-07-25
Start date
2014-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain related functional gastrointestinal disorders ("functional abdominal pain", Rome-III criteria H2a, H2b, H2d, H2d1

Interventions

Group 1: Intervention group: participation in the cognitive-behavioral program "Stop the pain with Happy Pingu". The program comprises six weekly sessions for the children in small groups (90 min each

Sponsors

Universität Potsdam Department Psychologie Beratungspsychologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for medical screening: - abdominal pain for at least 2 months - abdominal pain at least once per week - 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 - no time constraints for participation in training groups

Exclusion criteria

Exclusion criteria: exclusion criteria for medical screening: very limited german language skills; mental retardation; concomitant psychological treatment; at point of screening constant physician-prescribed treatment (psychological, medical) of gastrointestinal complaints; at point of screening participation in a training program for gastroinestinal complaints during the last 6 months; at point of screening participation in a clinical trial which might have effects on abdominal pain in the last 4 weeks; presentation of sibling aged 7-12 years with abdominal pain. Exclusion Criteria for study participation: - psychiatric disorder (internalizing) with primary treatment indication - severe externalizing disorder

Design outcomes

Primary

MeasureTime frame
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 childrens self-report (over 2 weeks).

Secondary

MeasureTime frame
Secondary efficacy endpoints are health-related quality of life and pain-related coping and cognitions. The secondary outcome variables will be assessed by self -report questionnare (each assessed at pre, post, 3- and 12 months follow-up). Following questionnaires are included: PedsQL, PPCI, KINDL-R. Parents report on childs quality of life (PedsQL proxy report).

Countries

Germany

Contacts

Public ContactPetra Warschburger

Lehrstuhl für Beratungspsychologie Department Psychologie Universität Potsdam

warschb@uni-potsdam.de0331/ 977-2988

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 19, 2026