Written Self-disclosure for Youth Abdominal Pain

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00062608
First received: June 9, 2003
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health care setting.We will implement a randomized, controlled trial (RCT) designed to compare health status in 140 youths (ages 12-18) with functional RAP assigned either to standard medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of health status are symptom severity and episode frequency, consistent with the definition of RAP. Secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. Total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following Baseline. Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the specific aims.


Condition Intervention Phase
Abdominal Pain
Behavioral: Written self-disclosure
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: RCT of Written Self-disclosure for Youth Abdominal Pain

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 160
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Ages 12-18.
  • Diagnosis of RAP by the examining pediatric gastroenterologist using Apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis).
  • Free of a known chronic health condition.
  • Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain.
  • Consents to complete the protocol over the next 6 months.
  • Parent(s) consents to participate and agrees to support the youth in completing the protocol.
  • Access to a phone on the days writing sessions are to be completed at home.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062608

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00062608     History of Changes
Other Study ID Numbers: RCTYAP (completed)
Study First Received: June 9, 2003
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Abdominal

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 16, 2014