Intensive Outpatient Services for Teens

Depression Clinical Trial

— INVEST  

Official title:

Intensive Outpatient Protocol for High Risk Suicidal Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732601
• Other study ID #: 1R01MH097703-01
• Secondary ID: 1R01MH097703-01
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2012
• Last updated: January 21, 2018
• Start date: September 1, 2012
• Est. completion date: January 1, 2018

Study information

• Verified date: January 2018
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 1, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Suicide

Intervention

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.
• Standard Care
Treatment at step-down facilities

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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