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

August 19, 2011
August 22, 2011
October 4, 2016
August 2011
April 2015   (Final data collection date for primary outcome measure)
Unprotected Sex Acts [ Time Frame: Past 90 Days ]
Same as current
Complete list of historical versions of study NCT01421485 on Archive Site
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Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth
Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
HIV Prevention
  • Behavioral: Integrated treatment program
    CBT, psychopharmacological treatment, family treatment, HIV prevention, case management
  • Behavioral: Treatment as Usual
    Treatment in community, case management
  • Experimental: Integrated treatment Program
    Intervention: Behavioral: Integrated treatment program
  • Active Comparator: Treatment as Usual
    Intervention: Behavioral: Treatment as Usual
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2016
April 2015   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
1R01MH087520-01A2( U.S. NIH Grant/Contract )
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Rhode Island Hospital
Rhode Island Hospital
National Institute of Mental Health (NIMH)
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Rhode Island Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP