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Completed

NCT Number: NCT01421485

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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Key information

Conditions

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Integrated treatment program

Behavioral

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

Treatment as Usual

Behavioral

Treatment in community, case management

Primary outcomes

  1. Unprotected Sex Acts

    Time frame: Past 90 Days

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: ITP

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 22, 2011
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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