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Intensive Outpatient Services for Teens (INVEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT01732601
First received: November 13, 2012
Last updated: July 28, 2014
Last verified: July 2014

November 13, 2012
July 28, 2014
September 2012
June 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01732601 on ClinicalTrials.gov Archive Site
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
Same as current
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
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Suicide
  • 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
  • Behavioral: Standard Care
    Treatment at step-down facilities
    Other Names:
    • Treatment as Usual
    • Treatment in the Community
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2016
June 2016   (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
Both
12 Years to 18 Years
No
Contact: Tony Spirito, PhD 401-444-1929 anthony_spirito@brown.edu
Contact: Jennifer Wolff, PhD 401-444-3790 jennifer_wolff@brown.edu
United States
 
NCT01732601
1R01MH097703-01, 1R01MH097703-01
Yes
Anthony Spirito, Brown University
Brown University
National Institute of Mental Health (NIMH)
Principal Investigator: Anthony Spirito, PhD Brown University
Brown University
July 2014

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