- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01128777
Teens Coping With Parental Military Deployment (Helping Hand)
Mental Health Intervention for Teens Coping With Parental Military Deployment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02912
- Brown Univerity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adolescents must: 1) be 13-17 years old; 2) be English speaking; 3) provide adolescent assent; 4) have parental consent and a parent/legal guardian available to participate in the intervention protocol; 5) have a parent who is deployed or returned from a deployment within the last year; and 6) report current sub-clinical or clinical levels of depression, anxiety, or oppositional behavior. In order to meet the symptom criterion, adolescents must receive a T score of ≥ 65 on the affective problems, anxiety problems, and/or oppositional defiant problems on the Youth Self-Report or the Child Behavior Checklist.
Exclusion Criteria:
Adolescents who : 1) are developmentally delayed such that the intervention materials will not be appropriate; 2) are actively suicidal or psychotic at intake; 3) are receiving pharmacotherapy or psychotherapy in the community for depression, anxiety, or disruptive behavior which are the primary targets of this intervention; or 4) meet current criteria for a DSM-IV diagnosis of bipolar disorder, conduct disorder, substance dependence, or obsessive-compulsive disorder.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Cognitive behavioral group therapy
Cognitive behavioral group therapy for adolescents and a parallel group for parents
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The CBT group therapy protocol will teach adolescents coping, cognitive restructuring, and affect regulation skills to remediate skills deficits that underlie depression, anxiety, and behavior problems associated with the deployment cycle.
Parents will also learn stress management and parenting skills in their own group therapy sessions that occur as the same time as the adolescent group.
|
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ACTIVE_COMPARATOR: Nondirective supportive group therapy
Nondirective supportive group therapy for adolescents and a parallel group for parents
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Patient initiated discussions form the basis for the intervention for both the adolescent group and the parent group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Depressed mood
Time Frame: baseline, posttreatment, 3 month follow-up
|
baseline, posttreatment, 3 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Behavior problems
Time Frame: baseline, posttreatment, 3 month follow-up
|
baseline, posttreatment, 3 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH082164 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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