search
Back to results

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
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Suicide Attempt, Suicidal Ideation, NSSI, Substance Use

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 13, 2012
Last Updated
January 21, 2018
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
search

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

Learn more about this trial

Intensive Outpatient Services for Teens

We'll reach out to this number within 24 hrs