Intensive Outpatient Services for Teens

Study Overview
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Brief Summary
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This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.

Detailed Description
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Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and inpatient psychiatric hospitalization in this country. These expensive contacts with the health care system effectively address acute suicidality for many adolescents but there is a significant subset of suicidal patients that have continued suicidality. This study will target teens that are at risk for re-hospitalization based on continued suicidal ideation, their mood and another risk factor such as self-harm or substance use. These risk factors have been shown to increase risk for continued suicidal behavior and expensive contacts with the health care system. This protocol has been designed to determine whether Intensive Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood disorder, suicidal ideation, and substance use, will result in better treatment outcomes compared to standard care in the community. The Intensive CBT condition will be delivered by a team of two licensed mental health therapists over the course of one year and will work with both the teen and parent. The standard care condition will receive treatment in the community. One hundred-and fifty adolescents (38 a year) will be recruited from several inpatient and partial hospital locations. Each adolescent will receive a thorough baseline assessment to determine whether they are appropriate for the study and will be assigned to either the Intensive CBT condition or treatment within the community. Both groups of teens will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing over time.

Official Title
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Intensive Outpatient Protocol for High Risk Suicidal Teens

Conditions
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Depression, Suicide

Intervention / Treatment
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* Behavioral: Intensive Outpatient CBT
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Mood Disorder and suicidal ideation and one of the following NSSI Suicide Attempt Substance Use Exclusion Criteria: Intelligence Quotient < 80 Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa Adolescent use of illicit hard substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Outpatient CBT<br>Intensive CBT for both parents and adolescents as well as family sessions to increase communication. | Behavioral: Intensive Outpatient CBT<br>* Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.<br>* Other names: Intensive CBT for High Risk Teens with a mood disorder;|
| Active Comparator: Standard Care<br>Standard Treatment in the Community | Behavioral: Standard Care<br>* Treatment at step-down facilities<br>* Other names: Treatment as Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide attempts | Self-report by parents or teens of a suicide attempt occurring in the follow-up period | Measured at 18 months from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressed mood as assessed by the Children's Depression Rating Scale - Revised | Depressed mood as determined by clinical interview | Measured at 18 months from Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide Attempt, Suicidal Ideation, NSSI, Substance Use