Written Self-Disclosure for Youth Abdominal Pain - Tabular View

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Written Self-Disclosure for Youth Abdominal Pain

This study has been completed.

Study NCT00062608. Last updated on November 29, 2007. Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Written Self-Disclosure for Youth Abdominal Pain
Official Title ^†	RCT of Written Self-Disclosure for Youth Abdominal Pain
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.
Detailed Description
Study Phase	Phase II, Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Abdominal Pain
Intervention ^†	Behavioral: Written self-disclosure
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	160
Start Date ^†
Completion Date
Eligibility 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.
Gender	Both
Ages	12 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00062608
Organization ID	RCTYAP
Secondary IDs ^††
Study Sponsor ^†	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	November 2007
First Received Date ^†	June 9, 2003
Last Updated Date	November 29, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.