NCT01403298

Brief Summary

The purpose of this project is to compare the effect of a family-based HIV prevention program to the effect of an adolescent-only health promotion program on adolescent HIV risk and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island Family Court.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

3.5 years

First QC Date

March 28, 2011

Last Update Submit

May 8, 2020

Conditions

Keywords

AdolescentHIVAIDSSexual riskFamilyPreventionJuvenile Drug CourtJuvenile JusticeDrug UseMarijuana

Outcome Measures

Primary Outcomes (2)

  • adolescent HIV/STD risk

    Adolescent self-report of rates of condom use, number of sex partners, number of unprotected vaginal and/or anal intercourse episodes, frequency of alcohol use during sexual activity, frequency of marijuana use during sexual activity, frequency of other drug use during sexual activity

    3 months post intervention

  • adolescent substance use

    Adolescent self-report of quantity and frequency of marijuana use, alcohol use and other drug use over the past 3 months and over the past 30 days. Collateral urine toxicology screen data will also be available for analysis.

    3 months post-intervention

Secondary Outcomes (1)

  • Scores on measures of parent-child communication (general and sex-specific),parental monitoring and family emotional environment

    3 months post intervention

Study Arms (2)

Adolescent Only Health Promotion

ACTIVE COMPARATOR

An individual adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

Other: Adolescent Only Health Promotion

Family-Based HIV prevention

EXPERIMENTAL

This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.

Behavioral: Family-Based HIV prevention

Interventions

This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.

Family-Based HIV prevention

An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

Adolescent Only Health Promotion

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years old;
  • male and female;
  • in Rhode Island Family Court - Intake and Juvenile Drug Court program;
  • English speaking

You may not qualify if:

  • HIV infection (by self-report);
  • history of sex crimes,
  • current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMarijuana Abuse

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marina Tolou-Shams, PhD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

July 27, 2011

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations