CHOICES-TEEN Randomized Controlled Trial

NCT05368571 | Recruiting DMC

• 1 other identifier: R01DA050670
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Risk of AEP is defined as any risk drinking (\>3 drinks/day or \>7 drinks/week on average) and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported daily alcohol use (in standard drinks), vaginal intercourse, and contraception (effective use) data from the Timeline Followback will be used to calculate risk of AEP for the previous 90 days. Change in Risk of AEP will be examined at 3-, 6-, and 9-months post-intake. A participant will be considered at risk of AEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had more than 3 standard drinks on any day or more than 7 standard drinks per week on average in any 30 day period in the previous 90 days. Risk of AEP will be a dichotomous outcome (at risk of AEP or at reduced risk of AEP).

  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.

  Risk of MEP is defined as any day with marijuana use and any occurrence of vaginal sex with no use or ineffective use of contraception in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk of MEP for the previous 90 days at 3-, 6- , and 9 months post-intake. A participant will be considered at risk of MEP at each of the 3-, 6-, and 9 month timepoints if the participant had any occurrence of vaginal sex without the use of effective contraception and had any day with marijuana use in any 30 day period in the previous 90 days. Risk of MEP will be a dichotomous outcome (at risk of MEP or at reduced risk of MEP).

  3, 6, and 9 months

• Change in risk of HIV and STI

  Risk of HIV and STI is defined as any day with an occurrence of vaginal or anal sex without using a condom in the assessment period. Self-reported data from the Timeline Followback will be used to calculate risk HIV/STI risk for the previous 90 days at 3-, 6-, and 9 months post-intake. A participant will be considered at risk of HIV/STI at each of the 3-, 6- or 9 month timepoints if the participant had any occurrence of vaginal or anal sex without the use of a condom in any 30 day period in the previous 90 days. Risk of HIV/STI will be a dichotomous outcome (at risk of HIV/STI or not at risk of HIV/STI).

  3, 6, and 9 months

Study Arms (2)

CHOICES-TEEN

EXPERIMENTAL

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.

Other: CHOICES-TEEN

Health and Life Skills Education

ACTIVE COMPARATOR

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.

Other: Health and Life Skills Education

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.

CHOICES-TEEN

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.

Health and Life Skills Education

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: Identifies as female, and sex is female at birth.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Wayne State University: collaborator

Study Sites (1)

Baylor University

Houston, Texas, 77002, United States

RECRUITING

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Danielle E Parrish, Ph.D.

  Baylor University

  PRINCIPAL INVESTIGATOR

• Kirk L von Sternberg, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle E Parrish, Ph.D.

CONTACT

346-701-8047; danielle_parrish@baylor.edu

Kirk L von Sternberg, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Unique client ID numbers will be assigned to each program e.g. 2000 series, 3000 series, etc. Using RedCAP, each program's ID numbers will be randomly assigned to an intervention condition in advance. The condition assigned to each client ID number will be placed into an opaque envelope and these envelopes will be included in the intake packets for each new participant. The envelope with the condition assignment will be opened by the assessor after the conclusion of the assessment. Therefore, assessor, CHOICES-TEEN interventionist and study staff delivering the attention control condition will all be blind to condition during the intake assessment. Follow-up assessments will be done by study staff who are not providing the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Young women recruited from the four programs administered by HCJP will be randomized to the CHOICES-TEEN (CT) condition or the Attention Control (AC) condition. Randomization will be stratified by program such that women within each program will have an equal probability of being assigned to the CT or the AC condition.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: April 8, 2022
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)