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NCT00062608 Clinical Trial

Written Self-disclosure for Youth Abdominal Pain

Abdominal Pain Clinical Trial

Official title:
RCT of Written Self-disclosure for Youth Abdominal Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00062608
Other study ID # RCTYAP (completed)
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 9, 2003
Last updated January 12, 2010

Study information
Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility - 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an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis).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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Written self-disclosure

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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