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NCT01603563 · ClinicalTrials.gov registry record · Phase 1
Stepped Care for Young Children After Trauma
A Phase 1 study of Posttraumatic Stress Disorder, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT01603563 is a Phase 1 study of Posttraumatic Stress Disorder that has completed, run by University of South Florida. The registered enrollment target is 63 participants, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01603563, a Phase 1 study of Posttraumatic Stress Disorder, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures, treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the effectiveness of SC-TF-CBT for early childhood PTSD.
Conditions Studied
Interventions
- BEHAVIORAL Stepped Care TF-CBT
- BEHAVIORAL Standard TF-CBT
Study Locations (1)
Florida
- Crisis Center of Tampa Bay - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01603563
The ClinicalTrials.gov registry entry for NCT01603563 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (43% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Stepped Care TF-CBT is the first listed.
NCT01603563 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01603563 about?
NCT01603563 is a clinical study titled "Stepped Care for Young Children After Trauma". The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a smal...
What is the current status of trial NCT01603563?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2011-07. Estimated completion is 2014-11.
What conditions does trial NCT01603563 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT01603563?
The interventions under investigation include: Stepped Care TF-CBT (BEHAVIORAL), Standard TF-CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT01603563?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01603563 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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