Written Self-Disclosure for Youth Abdominal Pain

This study has been completed.

First Received: June 9, 2003 Last Updated: November 29, 2007 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00062608

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment
Official Title:	RCT of Written Self-Disclosure for Youth Abdominal Pain

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

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

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

More Information

No publications provided

Study ID Numbers:	RCTYAP
Study First Received:	June 9, 2003
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00062608 History of Changes
Health Authority:	United States: Federal Government

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

Abdominal

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain
Pain

ClinicalTrials.gov processed this record on July 06, 2009