NCT01421485

Brief Summary

Youth and young adults in the juvenile justice system have a high prevalence of concurrent psychiatric and substance use disorders and are also at high risk for HIV. However, even when the disorders and risks are recognized, most programs do not address all of these important problems and long-term efficacy for all outcomes simultaneously has yet to be demonstrated for these multi-problem youth. Adverse outcomes for youth include partially treated or relapsing psychiatric disorders, continued substance abuse, unchanged HIV risk, and further legal problems. This project, in collaboration with the Rhode Island Family Court, with whom we have existing collaborations, will address these issues by implementing an Integrated Treatment Program (ITP) that targets mental health/substance abuse disorders and HIV risk. ITP is novel by targeting multiple adolescent problems simultaneously, involving parents to augment change, and its delivery within the Family Court. This study will extend our previous efficacious interventions among youth with psychiatric disorders to court-involved youth. Adolescents and their parents will be enrolled from the Rhode Island Family Court Mental Health Clinic where youth aged 13-17 are referred by judges for comprehensive assessment and referral for treatment. This randomized controlled trial will test the efficacy, among 200 sexually active court-involved youth who need outpatient treatment, of the novel, integrated treatment (ITP, n=100) as compared to enhanced standard care in community outpatient services (ESC, n=100) over an 18-month period (6 months of ITP or ESC and 12 months of follow-up). ITP consists of three components: 1) individual cognitive behavioral therapy which includes a motivational interviewing component and is modular-based to address concurrent mental health and substance abuse issues; 2) family and parent training sessions to address parental communication and monitoring to support risk reduction among youth; 3) multifamily group workshops to address HIV risk, family communication and peer resistance skills. Youth in both conditions (ITP and ESC) will receive similar case management services from the court and psychiatric medication management (if needed) from a study psychiatrist. ITP will be compared to ESC on reductions in sexual risk behavior, substance use, symptoms of psychiatric disorders, and legal offenses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

August 19, 2011

Last Update Submit

October 3, 2016

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Unprotected Sex Acts

    Past 90 Days

Study Arms (2)

Integrated treatment Program

EXPERIMENTAL
Behavioral: Integrated treatment program

Treatment as Usual

ACTIVE COMPARATOR
Behavioral: Treatment as Usual

Interventions

Integrated treatment programBEHAVIORAL

CBT, psychopharmacological treatment, family treatment, HIV prevention, case management

Integrated treatment Program
Treatment as UsualBEHAVIORAL

Treatment in community, case management

Treatment as Usual

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • DSM-IV diagnosis of Obsessive Compulsive Disorder, Pervasive Developmental Disorder, or Schizophrenia as the primary, impairing diagnosis
  • IQ less than 70 as determined by the Kaufman Brief Intelligence Test-2 (K-BIT-2)
  • Sexual offense charge pending or conviction
  • Self-report of HIV infection
  • Self-report of current pregnancy
  • Wish to remain in mental health and/or medication treatment with an outside provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Olsen EM, Whiteley LB, Tolou-Shams M, Esposito-Smythers C, Brown LK. Family Factors Associated With Delinquency Outcomes in Court-Involved Youth in Mental Health Treatment. JAACAP Open. 2024 Jul 8;3(3):678-688. doi: 10.1016/j.jaacop.2024.05.004. eCollection 2025 Sep.

    PMID: 40922765DERIVED

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2015

Study Completion

August 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

US(1)