Intensive Outpatient Services for Teens (INVEST)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicide
• Intervention / Treatment: Behavioral: Intensive Outpatient CBT; Behavioral: Standard Care

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide attempts	Self-report by parents or teens of a suicide attempt occurring in the follow-up period	Measured at 18 months from Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressed mood as assessed by the Children's Depression Rating Scale - Revised	Depressed mood as determined by clinical interview	Measured at 18 months from Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse	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	Measures 18 months from Baseline

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Esposito-Smythers C, Wolff JC, Liu RT, Hunt JI, Adams L, Kim K, Frazier EA, Yen S, Dickstein DP, Spirito A. Family-focused cognitive behavioral treatment for depressed adolescents in suicidal crisis with co-occurring risk factors: a randomized trial. J Child Psychol Psychiatry. 2019 Oct;60(10):1133-1141. doi: 10.1111/jcpp.13095. Epub 2019 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Substance Use; Suicidal Ideation; Suicide Attempt; NSSI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 1R01MH097703-01 (U.S. NIH Grant/Contract)