Clinical trial NCT01732601: Intensive Outpatient Services for Teens
Official title: Intensive Outpatient Protocol for High Risk Suicidal Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Suicide
Keywords: Suicide Attempt
Suicidal Ideation
NSSI
Substance Use
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-11-26
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suicide attempts
timeFrame: Measured at 18 months from Baseline
Secondary outcomes:
measure: Depressed mood as assessed by the Children's Depression Rating Scale - Revised
timeFrame: Measured at 18 months from Baseline
Other outcomes:
measure: Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse
timeFrame: Measures 18 months from Baseline
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Anthony Spirito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.