Intensive Outpatient Services for Teens

Phase 1

Completed

• Conditions: Depression; Suicide
• Interventions: Behavioral: Standard Care; Behavioral: Intensive Outpatient CBT

• Registration Number: NCT01732601
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-26
• Primary Completion: 2017-10-01
• Status Verified: 2018-01
• Study Completion: 2018-01-01
• Last Update Submitted: 2018-01-21
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Standard Treatment in the Community
Intensive Outpatient CBT	Intensive Outpatient CBT	Intensive CBT for both parents and adolescents as well as family sessions to increase communication.

Primary Outcome Measures

Name	Time	Method
Suicide attempts	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

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

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States