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Teens Coping With Parental Military Deployment (Helping Hand)

Primary Purpose

Emotional Distress, Behavior Problems

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Group Therapy
Nondirective supportive group therapy
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Distress focused on measuring depression, anxiety, family conflict, behavior problems

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Brown Univerity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral group therapy

Nondirective supportive group therapy

Arm Description

Cognitive behavioral group therapy for adolescents and a parallel group for parents

Nondirective supportive group therapy for adolescents and a parallel group for parents

Outcomes

Primary Outcome Measures

Depressed mood

Secondary Outcome Measures

Behavior problems

Full Information

First Posted
May 21, 2010
Last Updated
July 3, 2013
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01128777
Brief Title
Teens Coping With Parental Military Deployment
Acronym
Helping Hand
Official Title
Mental Health Intervention for Teens Coping With Parental Military Deployment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to difficuly recruiting participants
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Behavior Problems
Keywords
depression, anxiety, family conflict, behavior problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral group therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral group therapy for adolescents and a parallel group for parents
Arm Title
Nondirective supportive group therapy
Arm Type
Active Comparator
Arm Description
Nondirective supportive group therapy for adolescents and a parallel group for parents
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nondirective supportive group therapy
Intervention Description
Patient initiated discussions form the basis for the intervention for both the adolescent group and the parent group
Primary Outcome Measure Information:
Title
Depressed mood
Time Frame
baseline, posttreatment, 3 month follow-up
Secondary Outcome Measure Information:
Title
Behavior problems
Time Frame
baseline, posttreatment, 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown Univerity
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Teens Coping With Parental Military Deployment

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