This trial is active, not recruiting.

Conditions depression, suicide
Treatments intensive outpatient cbt, standard care
Phase phase 1
Sponsor Brown University
Collaborator National Institute of Mental Health (NIMH)
Start date September 2012
End date June 2017
Trial size 140 participants
Trial identifier NCT01732601, 1R01MH097703-01


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
intensive outpatient cbt Intensive CBT for High Risk Teens with a mood disorder
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.
(Active Comparator)
Standard Treatment in the Community
standard care Treatment as Usual
Treatment at step-down facilities

Primary Outcomes

Suicide attempts
time frame: Measured at 18 months from Baseline

Secondary Outcomes

Depressed mood as assessed by the Children's Depression Rating Scale - Revised
time frame: Measured at 18 months from Baseline

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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

Additional Information

Official title Intensive Outpatient Protocol for High Risk Suicidal Teens
Principal investigator Anthony Spirito, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Brown University.