Clinical trial NCT02030392: A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Official title: "Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Abdominal Pain
Keywords: Functional abdominal pain
psychological intervention
quality of life
Randomized controlled trial
children
Lead sponsor: University of Potsdam
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 127
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain Symptoms
timeFrame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Secondary outcomes:
measure: Pain-related impairment
timeFrame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
measure: Health-related quality of life
timeFrame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
measure: Pain-related coping and cognitions
timeFrame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Medical Center, Pediatric Gastroenterology
city: Darmstadt
country: Germany
facility: Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
city: Düsseldorf
country: Germany
facility: University Medical Center, Pediatric Gastroenterology
city: Hamburg
country: Germany
facility: Catholic Children's Hospital Hamburg Wilhelmstift
city: Paderborn
country: Germany
facility: St. Vincenz Hospital
city: Ulm
country: Germany
facility: University Medical Center, Pediatric Gastroenterology
Study officials:
affiliation: University of Potsdam, Counselling Psychology
name: Petra Warschburger, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Groß, M. & Warschburger, P. (2013). Chronische Bauchschmerzen: Psychosoziale Belastung und behandlungsinduzierte Veränderungen in der Krankheitsbewältigung. Verhaltenstherapie, 23, 80-89. doi: 10.1159/000351215.
citation: Warschburger, P. & Groß, M. (2008). "Stopp den Schmerz" - ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Verhaltenstherapie, 18, 162-167.
citation: 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.
citation: 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.