Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth (ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421485
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : October 4, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: Integrated treatment program Behavioral: Treatment as Usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth
Study Start Date : August 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Integrated treatment Program Behavioral: Integrated treatment program
CBT, psychopharmacological treatment, family treatment, HIV prevention, case management

Active Comparator: Treatment as Usual Behavioral: Treatment as Usual
Treatment in community, case management

Primary Outcome Measures :
  1. Unprotected Sex Acts [ Time Frame: Past 90 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Adolescents from 13 -17 years of age who report unprotected sex in the past 90 days
  • Determined to be in need of mental health treatment by evaluation from the RIFC Mental Health Clinic and so ordered by the judge
  • Parent available to participate in the program
  • Parent and adolescent English speaking -Adolescent assent and parent/legal guardian consent. -

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421485

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Mental Health (NIMH)

Responsible Party: Rhode Island Hospital Identifier: NCT01421485     History of Changes
Other Study ID Numbers: 1R01MH087520-01A2 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016