Intensive Outpatient Services for Teens (INVEST)
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Purpose
This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Suicide |
Behavioral: Intensive Outpatient CBT Behavioral: Standard Care |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intensive Outpatient Protocol for High Risk Suicidal Teens |
- Suicide attempts [ Time Frame: Measured at 18 months from Baseline ] [ Designated as safety issue: No ]Self-report by parents or teens of a suicide attempt occurring in the follow-up period
- Depressed mood as assessed by the Children's Depression Rating Scale - Revised [ Time Frame: Measured at 18 months from Baseline ] [ Designated as safety issue: No ]Depressed mood as determined by clinical interview
- Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse [ Time Frame: Measures 18 months from Baseline ] [ Designated as safety issue: No ]Self report of behaviors considered self-harming including self-inflicted behaviors such as cutting with no suicidal intent or excessive substance use with negative consequences to the individual
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intensive Outpatient CBT
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
|
Behavioral: Intensive Outpatient CBT
Sessions will be delivered 2-3 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.
Other Name: Intensive CBT for Teens who have substance use, NSSI and a history of mood disorder and suicial ideation
|
|
Active Comparator: Standard Care
Standard Treatment in the Community
|
Behavioral: Standard Care
Treatment at step-down facilities
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Tony Spirito, PhD | 401-444-1929 | anthony_spirito@brown.edu |
| Contact: Jennifer Wolff, PhD | 401-444-3790 | jennifer_wolff@brown.edu |
| United States, Rhode Island | |
| Brown University | Recruiting |
| Providence, Rhode Island, United States, 02912 | |
| Contact: Anthony Spirito, PhD 401-444-1929 anthony_spirito@brown.edu | |
| Contact: Jennifer Wolff, PhD 401-444-3790 jennifer_wolff@brown.edu | |
| Principal Investigator: Anthony Spirito, PhD | |
| Principal Investigator: | Anthony Spirito, PhD | Brown University |
More Information
No publications provided
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT01732601 History of Changes |
| Other Study ID Numbers: | 1R01MH097703-01, 1R01MH097703-01 |
| Study First Received: | November 13, 2012 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Suicide Attempt Suicidal Ideation NSSI Substance Use |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Suicide Behavioral Symptoms |
Mood Disorders Mental Disorders Self-Injurious Behavior |
ClinicalTrials.gov processed this record on May 22, 2013