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Intensive Outpatient Services for Teens (INVEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732601
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : January 23, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, Brown University

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

Condition or disease Intervention/treatment Phase
Depression Suicide Behavioral: Intensive Outpatient CBT Behavioral: Standard Care Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Outpatient Protocol for High Risk Suicidal Teens
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
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 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.
Other Name: Intensive CBT for High Risk Teens with a mood disorder

Active Comparator: Standard Care
Standard Treatment in the Community
Behavioral: Standard Care
Treatment at step-down facilities
Other Name: Treatment as Usual

Primary Outcome Measures :
  1. Suicide attempts [ Time Frame: Measured at 18 months from Baseline ]
    Self-report by parents or teens of a suicide attempt occurring in the follow-up period

Secondary Outcome Measures :
  1. Depressed mood as assessed by the Children's Depression Rating Scale - Revised [ Time Frame: Measured at 18 months from Baseline ]
    Depressed mood as determined by clinical interview

Other Outcome Measures:
  1. Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse [ Time Frame: Measures 18 months from Baseline ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732601

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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
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Principal Investigator: Anthony Spirito, PhD Brown University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anthony Spirito, Professor, Brown University Identifier: NCT01732601    
Other Study ID Numbers: 1R01MH097703-01 ( U.S. NIH Grant/Contract )
1R01MH097703-01 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Anthony Spirito, Brown University:
Suicide Attempt
Suicidal Ideation
Substance Use
Additional relevant MeSH terms:
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Behavioral Symptoms
Self-Injurious Behavior