Viewing Study NCT01128777



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Last Modification Date: 2024-10-26 @ 10:20 AM
Study NCT ID: NCT01128777
Status: TERMINATED
Last Update Posted: 2013-07-04
First Post: 2010-05-21

Brief Title: Teens Coping With Parental Military Deployment
Sponsor: Brown University
Organization: Brown University

Study Overview

Official Title: Mental Health Intervention for Teens Coping With Parental Military Deployment
Status: TERMINATED
Status Verified Date: 2012-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Terminated due to difficuly recruiting participants
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Helping Hand
Brief Summary: The total number of military personnel is over 35 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 andor 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 intervention includes 12 adolescent group sessions which address depression anxiety and behavior problems associated with the deployment cycle and 12 parent group sessions that address stress management and parenting skills The non-directive supportive therapy condition includes 12 adolescent and 12 parent group sessions which involve patient initiated discussions focused on issues surrounding military deployment and re-integration Outcome will be assessed at post-treatment and 3 month follow-up The long term objective of this research is to yield an effective outpatient intervention for teens of military service members experiencing mental health problems associated with the deployment and re-integration phases of the deployment cycle
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R34MH082164 NIH None httpsreporternihgovquickSearchR34MH082164