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NCT Number: NCT02030392

A 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.

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Key information

Conditions

Functional Abdominal Pain Syndrome Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center, Pediatric Gastroenterology, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

Cognitive-behavioral intervention

Other names: Stop the pain with Happy Pingu

Active Control Group

Behavioral

Education and information

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Pain-related impairment

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

    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).

  2. Health-related quality of life

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

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

  3. Pain-related coping and cognitions

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

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

Sponsors and collaborators

Lead sponsor

University of Potsdam

Other

Registry information

Official study title

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

Acronym: Stop-FAP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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