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NCT01128777 · ClinicalTrials.gov registry record · Phase 1
Teens Coping With Parental Military Deployment
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01128777 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 6 participants.
The verdict
NCT01128777, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The total number of military personnel is over 3.5 million and approximately 43% have children. The deployment cycle can be associated with depression, anxiety, and behavior problems in children as well as psychological distress in the military spouse. Further, the health of family members can affect the physical and psychological functioning of the military service member during the deployment and re-integration periods. While research and federal funding has been dedicated toward developing treatments for the returning service member, intervention protocols for mental health problems in the children of military families have not been tested. In collaboration with the Family Readiness Program of the Rhode Island National Guard \& Reserves, the purpose of this proposal is to develop a cognitive behavioral treatment protocol for adolescents experiencing depression, anxiety, and/or behavior problems associated with the deployment and re-integration phases of the military deployment cycle. This protocol will be created by modifying an NIH funded cognitive behavioral protocol for the treatment of adolescent mental health problems with initial demonstrated efficacy (PI, C. Esposito-Smythers). There are three primary aims in this project: 1) develop the manualized intervention protocol for adolescents experiencing mental health problems associated with the deployment cycle; 2) refine and pilot the intervention protocol with 12 families; and 3) test the intervention in a randomized pilot trial. To accomplish these aims, a two step sequence of treatment development is proposed. Stage Ia includes initial manual development, focus groups, therapist training, and an open pilot trial. Stage Ib includes a randomized pilot trial. Seventy-two adolescents and their caretakers will be enrolled through the Rhode Island Family Readiness program and randomly assigned to the experimental intervention or non-directive supportive therapy for their outpatient care. The experimental interve
Interventions
- BEHAVIORAL Cognitive Behavioral Group Therapy
- BEHAVIORAL Nondirective supportive group therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128777
The ClinicalTrials.gov registry entry for NCT01128777 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Group Therapy is the first listed.
NCT01128777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128777 about?
NCT01128777 is a clinical study titled "Teens Coping With Parental Military Deployment". The total number of military personnel is over 3.5 million and approximately 43% have children. The deployment cycle can be associated with depression, anxiety, and behavior problems in children as well as psychological distress in the military spouse. Further, the health of family members can affec...
What is the current status of trial NCT01128777?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01128777?
The interventions under investigation include: Cognitive Behavioral Group Therapy (BEHAVIORAL), Nondirective supportive group therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01128777?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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