NCT02030392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

October 28, 2013

Last Update Submit

January 15, 2018

Conditions

Functional Abdominal Pain SyndromeAbdominal Pain

Keywords

Functional abdominal painpsychological interventionquality of lifeRandomized controlled trialchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain-related impairment

    up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

  • Health-related quality of life

    up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

  • Pain-related coping and cognitions

    up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Behavioral: Intervention group

Active control group

ACTIVE COMPARATOR

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).

Behavioral: Active control group

Interventions

Intervention groupBEHAVIORAL

Cognitive-behavioral intervention

Also known as: Stop the pain with Happy Pingu
Intervention group
Active control groupBEHAVIORAL

Education and information

Active control group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged 7-12 years
  • abdominal pain for at least 2 months
  • abdominal pain at least once per week
  • unclear cause for abdominal pain

You may not qualify if:

  • 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
  • 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
  • psychiatric disorder (internalizing) with primary treatment indication
  • severe externalizing disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Medical Center, Pediatric Gastroenterology

Berlin, 13353, Germany

Location

Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology

Darmstadt, 64287, Germany

Location

University Medical Center, Pediatric Gastroenterology

Düsseldorf, 40225, Germany

Location

Catholic Children's Hospital Hamburg Wilhelmstift

Hamburg, 22149, Germany

Location

St. Vincenz Hospital

Paderborn, 33098, Germany

Location

University Medical Center, Pediatric Gastroenterology

Ulm, 89075, Germany

Location

Related Publications (5)

  • 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.

    PMID: 22328460BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 25212457BACKGROUND

  • 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.

    PMID: 33767111DERIVED

Related Links

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Petra Warschburger, Professor

    University of Potsdam, Counselling Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 28, 2013

First Posted

January 8, 2014

Study Start

March 31, 2014

Primary Completion

July 7, 2017

Study Completion

July 7, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

DE(6)