CHOICES-TEEN Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-19
SponsorUniversity of Texas at Austin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

sexual intercourse with a male

inconsistent/ineffective condom use AND

inconsistent/ineffective contraception use

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHOICES-TEEN

    Other intervention

    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 intervention

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: CHOICES-TEENExperimental treatment 1 intervention
Group B: Health and Life Skills EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3, 6 and 9 months
2

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).

Time frame
3, 6, and 9 months
3

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).

Time frame
3, 6, and 9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Texas at Austin

Lead sponsor

Wayne State University

Collaborator