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

November 13, 2012
November 26, 2012
January 23, 2018
September 1, 2012
October 1, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01732601 on Archive Site
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
Same as current
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
Same as current
Intensive Outpatient Services for Teens
Intensive Outpatient Protocol for High Risk Suicidal Teens
This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Suicide
  • 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
  • Behavioral: Standard Care
    Treatment at step-down facilities
    Other Name: Treatment as Usual
  • Experimental: Intensive Outpatient CBT
    Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
    Intervention: Behavioral: Intensive Outpatient CBT
  • Active Comparator: Standard Care
    Standard Treatment in the Community
    Intervention: Behavioral: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 1, 2018
October 1, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R01MH097703-01( U.S. NIH Grant/Contract )
1R01MH097703-01 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Anthony Spirito, Brown University
Brown University
National Institute of Mental Health (NIMH)
Principal Investigator: Anthony Spirito, PhD Brown University
Brown University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP