Emotional DistressPhase 1Helping HandNCT01128777
Teens Coping With Parental Military Deployment
A Phase 1 study testing Cognitive Behavioral Group Therapy and Nondirective supportive group therapy in people with Emotional Distress and Behavior Problems, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Emotional Distress, Behavior Problems
- What is being tested?
- Cognitive Behavioral Group Therapy and Nondirective supportive group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Intervention for 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 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.
- Conditions
- Emotional Distress, Behavior Problems
- Being tested
- Cognitive Behavioral Group Therapy, Nondirective supportive group therapy
- Keywords
- depression, anxiety, family conflict, behavior problems
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
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.
Nondirective supportive group therapyBehavioural
Patient initiated discussions form the basis for the intervention for both the adolescent group and the parent group
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral group therapy | Experimental | Cognitive behavioral group therapy for adolescents and a parallel group for parents Receives: Behavioral: Cognitive Behavioral Group Therapy |
| Nondirective supportive group therapy | Active comparator | Nondirective supportive group therapy for adolescents and a parallel group for parents Receives: Behavioral: Nondirective supportive group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressed mood
Measured: baseline, posttreatment, 3 month follow-up
Secondary outcomes (1)
Behavior problems
Measured: baseline, posttreatment, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Terminated due to difficuly recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Anthony Spirito, National Institute of Mental Health (NIMH)
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128777
- Sponsor's protocol ID
- R34MH082164
- Other IDs
- R34MH082164
- Acronym
- Helping Hand
- Status last verified
- Jul 2012
- First submitted
- 21 May 2010
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Intervention for Teens Coping With Parental Military Deployment
- ClinicalTrials.gov ID
- NCT01128777
- Acronym / sponsor ID
- Helping Hand / R34MH082164
- Conditions
- Emotional Distress, Behavior Problems
- Keywords
- depression, anxiety, family conflict, behavior problems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to difficuly recruiting participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral group therapy | Experimental | Behavioral: Cognitive Behavioral Group TherapyCognitive behavioral group therapy for adolescents and a parallel group for parents |
| Nondirective supportive group therapy | Active comparator | Behavioral: Nondirective supportive group therapyNondirective supportive group therapy for adolescents and a parallel group for parents |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Group TherapyThe 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. | Behavioural | Cognitive behavioral group therapy |
| Nondirective supportive group therapyPatient initiated discussions form the basis for the intervention for both the adolescent group and the parent group | Behavioural | Nondirective supportive group therapy |
Primary outcome
Depressed mood
Time frame: baseline, posttreatment, 3 month follow-up
1 secondary outcome
Behavior problems
Time frame: baseline, posttreatment, 3 month follow-up
Results and safety
The study was stopped early (reason given: Terminated due to difficuly recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Spirito, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Behavioral Group Therapy and Nondirective supportive group therapy in people with Emotional Distress and Behavior Problems, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to difficuly recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressed mood (time frame: baseline, posttreatment, 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013; AzTrials last refreshed its copy on 1 Nov 2026.