Recruiting

CHOICES-TEEN

Sponsor:

University of Texas at Austin

Code:

NCT05368571

Conditions

Risk for an Alcohol-Exposed Pregnancy

Risk for Marijuana-Exposed Pregnancy

Risk for Substance-Exposed Pregnancy

HIV Risk

Sexually Transmitted Infection Risk

Eligibility Criteria

Sex: Female

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

CHOICES-TEEN

Health and Life Skills Education

Study Details

Brief summary:

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.

Conditions

Risk for an Alcohol-Exposed Pregnancy

Risk for Marijuana-Exposed Pregnancy

Risk for Substance-Exposed Pregnancy

HIV Risk

Sexually Transmitted Infection Risk

Study ID

NCT05368571

Start date

Apr 8, 2022

Status verified date

Jun, 2025

Completion date

Apr 10, 2026

Anticipated

Primary completion date

Apr 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

Female adolescents between 14-19 years of age, of any race, who are at risk of substance-exposed pregnancy and HIV/STI will be eligible. Specifically, they must report the following behaviors within the last 3 months:

  • sexual intercourse with a male
  • inconsistent/ineffective condom use AND
  • inconsistent/ineffective contraception use

Exclusion Criteria:

  • severe cognitive and/or psychiatric impairment that precludes cooperation with study protocol, per judgement of the interventionist or research staff
  • do not speak or read/write in English
  • unable to meet study requirements, including follow-up assessments

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

CHOICES-TEEN

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

This is a four-session psychoeducational intervention that is designed to provide information on time management, sleep, nutrition and exercise, and financial management.

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 ]
  • Change in risk of marijuana-exposed pregnancy (MEP) as measured by self-reported marijuana use, vaginal sex, and use of contraception on the Timeline Followback calendar. [ Time Frame: 3, 6, and 9 months ]
  • Change in risk of HIV and STI [ Time Frame: 3, 6, and 9 months ]

Central Contacts and Locations

Central contacts

Danielle E Parrish, Ph.D.

346-701-8047danielle_parrish@baylor.edu

Kirk L von Sternberg, Ph.D.

512-232-0633vonsternberg@mail.utexas.edu

Locations

Baylor University

Recruiting

Houston, Texas, United States, 77002

Contacts

Danielle E Parrish, Ph.D.

346-701-8047danielle_parrish@baylor.edu

Kirk L von Sternberg, Ph.D.

512-232-0633vonsternberg@mail.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-06-19.