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Intensive Outpatient Services for Teens (INVEST)

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Brown University

Status and phase

Completed
Phase 1

Conditions

Depression
Suicide

Treatments

Behavioral: Standard Care
Behavioral: Intensive Outpatient CBT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01732601
1R01MH097703-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

140 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Intensive Outpatient CBT
Experimental group
Description:
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
Treatment:
Behavioral: Intensive Outpatient CBT
Standard Care
Active Comparator group
Description:
Standard Treatment in the Community
Treatment:
Behavioral: Standard Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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