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NCT01603563 · ClinicalTrials.gov registry record · Phase 1
Stepped Care for Young Children After Trauma
A Phase 1 study of Post Traumatic Stress Disorder, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT01603563: Completed Phase 1 study of Post Traumatic Stress Disorder, sponsored by University of South Florida.
NCT01603563 is a Phase 1 study of Post Traumatic Stress Disorder that has completed, run by University of South Florida. The registered enrollment target is 63 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603563, a Phase 1 study of Post Traumatic 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.
Primary Outcome
Change from baseline in Diagnostic Preschool Infant Assessment PTSD module (DIPA; Scheeringa, 2010) and in the Trauma Symptom Checklist for Young Children (Briere et al., 2001) at 14 weeks and 3 month follow up
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 |
What the finished NCT01603563 record still lists
NCT01603563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Stepped Care TF-CBT is the first listed.
NCT01603563 reports a single indexed study location in 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: Post Traumatic 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.
Learn More About Clinical Trials
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Where NCT01603563's enrollment target sits among peer trials
63 159th of 262 higher than 104 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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