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Health and Life Skills Education for Preventing STIs and Substance-Exposed Pregnancy

N/A

Recruiting

Led By Danielle E Parrish, Ph.D.

Research Sponsored by Baylor University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, inconsistent/ineffective contraception use

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 9 months

Awards & highlights

Study Summary

This trial will test if an intervention called CHOICES-TEEN can reduce the risk of substance-exposed pregnancy and HIV/STI among high-risk female youth involved with the juvenile justice system.

Who is the study for?

This trial is for female teens aged 14-17 involved with the juvenile justice system, at risk of pregnancy and HIV/STI due to alcohol use, marijuana use, and unprotected sex. They must be able to follow the study plan and speak/read English.Check my eligibility

What is being tested?

The CHOICES-TEEN (CT) program aims to reduce substance-exposed pregnancies and HIV/STI risks by promoting sobriety from alcohol and marijuana, safe sex practices, and better decision-making compared to a standard health education program.See study design

What are the potential side effects?

There are no direct medical side effects as this is an educational intervention. However, participants may experience discomfort discussing personal habits or feel stress when trying to change behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a female aged 14-19 at risk of pregnancy or HIV/STI due to recent unprotected sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV

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.

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CHOICES-TEENExperimental Treatment1 Intervention

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.

Group II: Health and Life Skills EducationActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wayne State UniversityOTHER

307 Previous Clinical Trials

108,073 Total Patients Enrolled

Baylor UniversityLead Sponsor

55 Previous Clinical Trials

64,752 Total Patients Enrolled

University of Texas at AustinOTHER

353 Previous Clinical Trials

80,844 Total Patients Enrolled

Media Library

CHOICES-TEEN Clinical Trial Eligibility Overview. Trial Name: NCT05368571 — N/A

Substance-Exposed Pregnancy Research Study Groups: CHOICES-TEEN, Health and Life Skills Education

Substance-Exposed Pregnancy Clinical Trial 2023: CHOICES-TEEN Highlights & Side Effects. Trial Name: NCT05368571 — N/A

CHOICES-TEEN 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368571 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process still open for this clinical trial?

"Per the clinicaltrials.gov records, this medical experiment is still actively looking for participants since its initial posting on May 30th 2022 and last update 6 days ago."

Answered by AI

Is participation in this trial open to the public?

"This clinical trial is recruiting 400 individuals aged 14-17 with a potential for an alcohol-exposed pregnancy. Eligible participants must fulfill the following requirements: female adolescents between 14 and 17 years of age, reporting sexual intercourse with males in the past three months along with either inconsistent or ineffective condom/contraceptive use; drinking four or more drinks on single occasions, eight or more drinks per week, using marijuana twice or more during that same period; and being at risk of contracting HIV/STIs."

Answered by AI

Are individuals of all ages being considered for participation in this experiment?

"The inclusion criteria for this trial state that prospective enrollees must be aged between 14 and 17, inclusive."

Answered by AI

What is the scope of participants for this research endeavor?

"That is correct. According to clinicaltrials.gov, this investigation has been actively recruiting since May 30th 2022 and was recently refreshed on the 6th of May. The research necessitates 400 individuals from just one medical establishment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CHOICES-TEEN Randomized Controlled Trial

2022. "CHOICES-TEEN Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368571.