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

Abdominal Pain Clinical Trial

— Stop-FAP  

Official title:

"Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030392
• Other study ID #: WA1143/9-1
• Secondary ID: DRKS00005038
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: January 15, 2018
• Start date: March 31, 2014
• Est. completion date: July 7, 2017

Study information

• Verified date: January 2018
• Source: University of Potsdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain Syndrome

Intervention

Behavioral:
• Intervention group
Cognitive-behavioral intervention
• Active control group
Education and information

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Potsdam

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Symptoms	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 children's self-report (over 2 weeks).Statistically, the primary endpoint of the study is defined as the change of the logarithm of the area under the pain-intensity curve over one week from start of treatment to 12 month follow-up. The area under the pain intensity curve (auc) is a measure that reflects pain intensity as well as pain duration and pain frequency and thus can be understood as a composite measure of pain.	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Secondary	Pain-related impairment	A measure for child's functional disability due to pain. The measure is one scale score and covers the level of impairment in everyday activitites due to abdominal pain by 12 items, e.g. reading, meeting friends, family life. The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Secondary	Health-related quality of life	The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Secondary	Pain-related coping and cognitions	The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).	up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

External Links

•   Description of research project
•   Homepage Counseling Psychology, Prof. Warschburger