Intensive Outpatient Services for Teens

NCT ID: NCT01732601

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2018-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive Outpatient CBT

Intensive CBT for both parents and adolescents as well as family sessions to increase communication.

Group Type EXPERIMENTAL

Intensive Outpatient CBT

Intervention Type 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.

Standard Care

Standard Treatment in the Community

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Treatment at step-down facilities

Interventions

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Intensive 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.

Intervention Type BEHAVIORAL

Standard Care

Treatment at step-down facilities

Intervention Type BEHAVIORAL

Other Intervention Names

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Intensive CBT for High Risk Teens with a mood disorder Treatment as Usual

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Anthony Spirito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony Spirito, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31328281 (View on PubMed)

Other Identifiers

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1R01MH097703-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH097703-01

Identifier Type: NIH

Identifier Source: org_study_id

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