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Completed

NCT Number: NCT01732601

Intensive Outpatient Services for Teens

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Self-Injurious Behavior Substance-Related Disorders Suicidal Ideation Suicide Suicide, Attempted

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Outpatient CBT

Behavioral

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 names: Intensive CBT for High Risk Teens with a mood disorder

Standard Care

Behavioral

Treatment at step-down facilities

Other names: Treatment as Usual

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Intensive Outpatient Protocol for High Risk Suicidal Teens

Acronym: INVEST

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 26, 2012
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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