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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Potsdam

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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). A detailed description of measures will be added in the course of preparation phase.
  • 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 ]
  • Pain-related self-efficacy [ Time Frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up ]


Original Secondary Outcome:

  • 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). A detailed description of measures will be added in the course of preparation phase.
  • Pain-related coping [ Time Frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up ]
  • Pain-related cognitions [ Time Frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up ]


Information By: University of Potsdam

Dates:
Date Received: October 28, 2013
Date Started: April 2014
Date Completion: September 2017
Last Updated: March 24, 2016
Last Verified: March 2016