Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062608
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2003-06-09
Brief Title:
Written Self-disclosure for Youth Abdominal Pain
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
RCT of Written Self-disclosure for Youth Abdominal Pain
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 settingWe 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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: