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Intensive Outpatient Services for Teens

Intensive Outpatient Protocol for High Risk Suicidal Teens

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01732601
Acronym
INVEST
Enrollment
140
Registered
2012-11-26
Start date
2012-09-01
Completion date
2018-01-01
Last updated
2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicide

Keywords

Suicide Attempt, Suicidal Ideation, NSSI, Substance Use

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.

Interventions

BEHAVIORALIntensive Outpatient CBT

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.

BEHAVIORALStandard Care

Treatment at step-down facilities

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Suicide attemptsMeasured at 18 months from BaselineSelf-report by parents or teens of a suicide attempt occurring in the follow-up period

Secondary

MeasureTime frameDescription
Depressed mood as assessed by the Children's Depression Rating Scale - RevisedMeasured at 18 months from BaselineDepressed mood as determined by clinical interview

Other

MeasureTime frameDescription
Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuseMeasures 18 months from BaselineSelf 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026