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

HIV Prevention Clinical Trial

— ITP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421485
• Other study ID #: 1R01MH087520-01A2
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: October 3, 2016
• Start date: August 2011
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• Integrated treatment program
CBT, psychopharmacological treatment, family treatment, HIV prevention, case management
• Treatment as Usual
Treatment in community, case management

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected Sex Acts		Past 90 Days	No