Written Self-disclosure for Youth Abdominal Pain

NCT ID: NCT00062608

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL

Brief 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.

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Written self-disclosure

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis).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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

RCTYAP (completed)

Identifier Type: -

Identifier Source: org_study_id