Trial record 6 of 31 for:    " July 20, 2011":" August 19, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01421485
First received: August 19, 2011
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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 Intervention
HIV Prevention
Behavioral: Integrated treatment program
Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Integrated Mental Health Treatment & HIV Prevention for Court-Involved Youth

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Unprotected Sex Acts [ Time Frame: Past 90 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421485

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Larry K Brown, MD    401-444-8539    lkbrown@lifespan.org   
Principal Investigator: Larry K Brown, M.D.         
Sponsors and Collaborators
Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01421485     History of Changes
Other Study ID Numbers: 1R01MH087520-01A2
Study First Received: August 19, 2011
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014