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Home > "R" Clinical Trials Conditions > RCT of Written Self-disclosure for Youth Abdominal Pain  RCT of Written Self-disclosure for Youth Abdominal Pain
RCT of Written Self-disclosure for Youth Abdominal Pain
For Condition: Abdominal Pain
Status: Not yet recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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 RCT design 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Single Group Assignment
Minimum Age/Maximum Age: 12 Years/18 Years
Genders: Both
Protocol Entry Criteria: (1) Ages 12-18. (2) 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an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis). (3) Free of a known chronic health condition. (4) Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain. (5) Consents to complete the protocol over the next 6 months. (6) Parent(s) consents to participate and agrees to support the youth in completing the protocol. (7) Access to a phone on the days writing sessions are to be completed at home.
Total Enrollment: 160
Location and Contact Information:
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Jan Wallander
Additional Information:
Study ID Numbers: RCTYAP;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062608
Other Abdominal Pain Studies:
1. Treatment of Functional Bowel Disorders
2. RCT of Written Self-disclosure for Youth Abdominal Pain
3. Migraine and Recurrent Abdominal Pain in Children
Related Studies:
Other Abdominal Pain Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
RCT of Written Self-disclosure for Youth Abdominal Pain
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