Intensive Outpatient Services for Teens (INVEST)

• ClinicalTrials.gov Identifier: NCT01732601
• Recruitment Status: Completed
• First Posted: November 26, 2012
• Last Update Posted: January 23, 2018
• Sponsor: Brown University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Anthony Spirito, Brown University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depression; Suicide	Behavioral: Intensive Outpatient CBT; Behavioral: Standard Care	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intensive Outpatient Protocol for High Risk Suicidal Teens
• Actual Study Start Date: September 1, 2012
• Actual Primary Completion Date: October 1, 2017
• Actual Study Completion Date: January 1, 2018

Arms and Interventions

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 Name: 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 Name: Treatment as Usual

Outcome Measures

Primary Outcome Measures :

1. Suicide attempts [ Time Frame: 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 :

1. Depressed mood as assessed by the Children's Depression Rating Scale - Revised [ Time Frame: Measured at 18 months from Baseline ]
   Depressed mood as determined by clinical interview

Other Outcome Measures:

1. Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse [ Time Frame: Measures 18 months from Baseline ]
   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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

Brown University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Anthony Spirito, PhD; Brown University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Anthony Spirito, Professor, Brown University
• ClinicalTrials.gov Identifier: NCT01732601
• Other Study ID Numbers: 1R01MH097703-01 ( U.S. NIH Grant/Contract ); 1R01MH097703-01 ( U.S. NIH Grant/Contract )
• First Posted: November 26, 2012
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

Keywords provided by Anthony Spirito, Brown University:

Suicide Attempt; Suicidal Ideation; NSSI; Substance Use

Additional relevant MeSH terms:

Suicide; Behavioral Symptoms; Self-Injurious Behavior