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Functional Abdominal Pain SyndromeStop-FAPNCT02030392

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

A study testing Intervention group in people with Functional Abdominal Pain Syndrome and Abdominal Pain, run by University of Potsdam at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 7 to 12 years
What is being tested?
Intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
6 sitesGermany
Study dates
31 Mar 2014to 7 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • aged 7-12 years
  • abdominal pain for at least 2 months
  • abdominal pain at least once per week
  • unclear cause for abdominal pain
  • pain-predominant functional gastrointestinal disorders according to Rome-III
  • criteria (H2a, H2b, H2d, H2d1)
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  • informed consent for study particiaption
  • informed consent for audiotaping of trainings sessions
  • no time constraints for participation in training groups

Who cannot join

  • 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
Show all 9Show fewer
  • presentation of sibling aged 7-12 years
  • psychiatric disorder (internalizing) with primary treatment indication
  • severe externalizing disorder

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • University Medical Center, Pediatric Gastroenterology

    Berlin, 13353

  • Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology

    Darmstadt, 64287

  • University Medical Center, Pediatric Gastroenterology

    Düsseldorf, 40225

  • Catholic Children's Hospital Hamburg Wilhelmstift

    Hamburg, 22149

  • St. Vincenz Hospital

    Paderborn, 33098

  • University Medical Center, Pediatric Gastroenterology

    Ulm, 89075

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Intervention group, Active control group
Keywords
Functional abdominal pain, psychological intervention, quality of life, Randomized controlled trial, children
Medical subject headings
Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention groupBehavioural

    Also called Stop the pain with Happy Pingu

    Cognitive-behavioral intervention

  • Active control groupBehavioural

    Education and information

Study groups in NCT02030392
Study groupRoleWhat they receive
Intervention groupExperimentalIG 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).
Receives: Behavioral: Intervention group
Active control groupActive comparatorCG 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).
Receives: Behavioral: Active control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. 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).

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

  2. Health-related quality of life

    The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).

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

  3. Pain-related coping and cognitions

    The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2014 (estimated)
  2. Study start31 Mar 2014
  3. Primary completion7 Jul 2017
  4. Study completion7 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02030392
Sponsor's protocol ID
WA1143/9-1
Other IDs
DRKS00005038
Acronym
Stop-FAP
Status last verified
Jan 2018
First submitted
28 Oct 2013
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22328460

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

  • 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.

    PubMed 25212457

  • 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.

    PubMed 33767111

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group in people with Functional Abdominal Pain Syndrome and Abdominal Pain, run by University of Potsdam at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Symptoms (time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030392, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018; AzTrials last refreshed its copy on 28 Oct 2026.

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