CHOICES-TEEN Randomized Controlled Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT05368571
Status
Recruiting
Apply to this trial

Conditions

  • HIV Risk
  • Risk for Marijuana-Exposed Pregnancy
  • Risk for Substance-Exposed Pregnancy
  • Risk for an Alcohol-Exposed Pregnancy
  • Sexually Transmitted Infection Risk

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • CHOICES-TEEN — OTHER
    This is a four-session hybrid in-person and Telehealth counseling intervention that is designed to reduce the risk of HIV/STI and alcohol- and marijuana-exposed pregnancy for young women who are involved in the juvenile justice system between the ages of 14-19.
  • Health and Life Skills Education — OTHER
    This is a four-session psychoeducational intervention that is designed to provide information on time management, sleep, nutrition and exercise, and financial management.

Study Details

This randomized controlled trial will: 1) Test the efficacy of the CHOICES-TEEN (CT) intervention compared with an Attentional Control (AC) condition on reducing the risk of substance-exposed pregnancy (SEP) and HIV/STI among high-risk female youth involved with the juvenile justice system by reducing alcohol use, increasing marijuana cessation, reducing risk of pregnancy, and increasing condom use; 2) Test the efficacy of CT, compared to AC, on increasing cognitive self-regulation abilities; 3) Test proposed intervention mediators/mechanisms of action for CT overall and by race/ethnicity; and 4) Test the moderating effect of initial readiness to change on risk of SEP and risk of HIV/STI.

Key Dates

Start date
Apr 8, 2022
Status verified
Jun 2025
Primary completion
Apr 10, 2026
Completion
Apr 10, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CHOICES-TEEN
    This is a four session session utilizing Motivational Interviewing (MI) and cognitive-behavioral approaches to enhance motivation for change in one or more primary behaviors: alcohol, marijuana, and condom/contraceptive use. The intervention is delivered by a trained master's level counselor and an Adolescent Medicine Specialist using one in-person session, and three Telehealth sessions.
  • Active Comparator: Health and Life Skills Education
    This four session life skills education program provides detailed information on time management, sleep, nutrition and exercise, and financial management. This program is delivered in person for the first session and then by Telehealth platform.

Primary Outcome Measure

Change in risk of alcohol-exposed pregnancy (AEP) as measured by self-reported daily standard drinks, vaginal sex, and use of contraception on the Timeline Followback calendar. [ Time Frame: 3, 6 and 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor UniversityHoustonTexas77002
Danielle E Parrish, Ph.D.
[email protected]
346-701-8047
Kirk L von Sternberg, Ph.D.
[email protected]
512-232-0633

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By research site
Baylor University· Houston, TX

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