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NCT00062608 · ClinicalTrials.gov registry record · Phase 2
Written Self-disclosure for Youth Abdominal Pain
A Phase 2 study of Abdominal Pain, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT00062608 is a Phase 2 study of Abdominal Pain that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 160 participants, above the 142-participant average among 19 other Abdominal Pain trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00062608, a Phase 2 study of Abdominal Pain, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BEHAVIORAL Written self-disclosure
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00062608
The ClinicalTrials.gov registry entry for NCT00062608 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 142-participant average among 19 other Abdominal Pain trials with a reported enrollment target (13% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Abdominal Pain appearing as the primary indexed condition, and to 1 intervention - of which Written self-disclosure is the first listed.
NCT00062608 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT00062608 about?
NCT00062608 is a clinical study titled "Written Self-disclosure for Youth Abdominal Pain". 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 a...
What is the current status of trial NCT00062608?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants.
What conditions does trial NCT00062608 study?
This clinical trial studies the following conditions: Abdominal Pain.
What interventions are being tested in trial NCT00062608?
The interventions under investigation include: Written self-disclosure (BEHAVIORAL).
Who is sponsoring clinical trial NCT00062608?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00062608 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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