Intensive Outpatient Services for Teens (INVEST)
Primary Purpose
Depression, Suicide
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intensive Outpatient CBT
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Suicide Attempt, Suicidal Ideation, NSSI, Substance Use
Eligibility 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
Sites / Locations
- Brown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive Outpatient CBT
Standard Care
Arm Description
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
Standard Treatment in the Community
Outcomes
Primary Outcome Measures
Suicide attempts
Self-report by parents or teens of a suicide attempt occurring in the follow-up period
Secondary Outcome Measures
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
Depressed mood as determined by clinical interview
Full Information
NCT ID
NCT01732601
First Posted
November 13, 2012
Last Updated
January 21, 2018
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01732601
Brief Title
Intensive Outpatient Services for Teens
Acronym
INVEST
Official Title
Intensive Outpatient Protocol for High Risk Suicidal Teens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicide
Keywords
Suicide Attempt, Suicidal Ideation, NSSI, Substance Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Outpatient CBT
Arm Type
Experimental
Arm Description
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard Treatment in the Community
Intervention Type
Behavioral
Intervention Name(s)
Intensive Outpatient CBT
Other Intervention Name(s)
Intensive CBT for High Risk Teens with a mood disorder
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment at step-down facilities
Primary Outcome Measure Information:
Title
Suicide attempts
Description
Self-report by parents or teens of a suicide attempt occurring in the follow-up period
Time Frame
Measured at 18 months from Baseline
Secondary Outcome Measure Information:
Title
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
Description
Depressed mood as determined by clinical interview
Time Frame
Measured at 18 months from Baseline
Other Pre-specified Outcome Measures:
Title
Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse
Description
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
Time Frame
Measures 18 months from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31328281
Citation
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.
Results Reference
derived
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Intensive Outpatient Services for Teens
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