Clinical trial NCT01128777: Teens Coping With Parental Military Deployment
Official title: Mental Health Intervention for Teens Coping With Parental Military Deployment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Emotional Distress
Behavior Problems
Keywords: depression
anxiety
family conflict
behavior problems
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-24
Enrollment: 6
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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Primary outcomes:
measure: Depressed mood
timeFrame: baseline, posttreatment, 3 month follow-up
Secondary outcomes:
measure: Behavior problems
timeFrame: baseline, posttreatment, 3 month follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown Univerity
state: Rhode Island
Study officials:
affiliation: Brown University
name: Anthony Spirito, PhD
role: PRINCIPAL_INVESTIGATOR
References: