Intensive Outpatient Services for Teens (INVEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT01732601
First received: November 13, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Depression
Suicide
Behavioral: Intensive Outpatient CBT
Behavioral: Standard Care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Outpatient Protocol for High Risk Suicidal Teens

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Suicide attempts [ Time Frame: Measured at 18 months from Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured at 18 months from Baseline ] [ Designated as safety issue: No ]
    Depressed mood as determined by clinical interview


Other Outcome Measures:
  • Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse [ Time Frame: Measures 18 months from Baseline ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 2-3 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 Teens who have substance use, NSSI and a history of mood disorder and suicial ideation
Active Comparator: Standard Care
Standard Treatment in the Community
Behavioral: Standard Care
Treatment at step-down facilities
Other Names:
  • Treatment as Usual
  • Treatment in the Community

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732601

Contacts
Contact: Tony Spirito, PhD 401-444-1929 anthony_spirito@brown.edu
Contact: Jennifer Wolff, PhD 401-444-3790 jennifer_wolff@brown.edu

Locations
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Anthony Spirito, PhD    401-444-1929    anthony_spirito@brown.edu   
Contact: Jennifer Wolff, PhD    401-444-3790    jennifer_wolff@brown.edu   
Principal Investigator: Anthony Spirito, PhD         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01732601     History of Changes
Other Study ID Numbers: 1R01MH097703-01, 1R01MH097703-01
Study First Received: November 13, 2012
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Brown University:
Suicide Attempt
Suicidal Ideation
NSSI
Substance Use

Additional relevant MeSH terms:
Depression
Suicide
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on September 18, 2014