RECRUITING

Preconception Intervention for Incarcerated Women With Substance Use

Conditions

Substance Use Disorders Preconception Health Motivational Interviewing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this pilot trial is to test the feasibility and acceptability as well as efficacy of the adapted intervention, CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) among women will illicit polysubstance use participating in a court-mandated jail-based 90-day substance use disorder treatment program. The main questions it aims to answer are: 1. What is the feasibility and acceptability of implementing the CHOICES-PLEAS intervention in a court-mandated jail-based substance use disorder treatment program? 2. Does participation in CHOICES-PLEAS lower the risk of a substance exposed pregnancy at 1 and 3 months after release compared to a control condition? 3. Does participation in CHOICES-PLEAS increase motivation to change substance use and reduce risky sexual behaviors at 1 and 3 months after release compared to a control condition? Participants will receive three one-on-one motivational interviewing sessions and one family planning referral visit during incarceration and one booster session at 1 month after release from jail. Researchers will compare the CHOICES-PLEAS intervention to a control condition to see if participation in the intervention reduces risk of substance exposed pregnancy, increases motivation to change substance use, and reduces risk of risky sexual behaviors.

Official Title

A Preconception Health Intervention to Reduce Substance Exposed Pregnancies Among Incarcerated Women

Quick Facts

Study Start:2023-12-04

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05854836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* English-speaking * Capable of becoming pregnant (did not undergo a permanent sterilization procedure and not using a highly effective long-acting reversible birth control method, i.e. intrauterine device or implant.) * During the three year prior to arrest or entering the treatment program engaged in vaginal sex with a male partner. * During the three months prior to arrest or entering the treatment program used at least one substance (heroin, fentanyl, opioids, cocaine, methamphetamine, or marijuana or alcohol with another substance).	* Participated in a focus group that was part of the formative work for this study to create the intervention adaptation * Non-English-speaking * Not capable of pregnancy (underwent a permanent sterilization procedure or using a long-acting reversible contraceptive method) * No vaginal sex with a male partner in the 3 years prior to incarceration or entering the treatment program. * No use of an illicit substance, such as only alcohol or marijuana use not in combination with another substance

Inclusion Criteria

Exclusion Criteria

* English-speaking
* Capable of becoming pregnant (did not undergo a permanent sterilization procedure and not using a highly effective long-acting reversible birth control method, i.e. intrauterine device or implant.)
* During the three year prior to arrest or entering the treatment program engaged in vaginal sex with a male partner.
* During the three months prior to arrest or entering the treatment program used at least one substance (heroin, fentanyl, opioids, cocaine, methamphetamine, or marijuana or alcohol with another substance).

* Participated in a focus group that was part of the formative work for this study to create the intervention adaptation
* Non-English-speaking
* Not capable of pregnancy (underwent a permanent sterilization procedure or using a long-acting reversible contraceptive method)
* No vaginal sex with a male partner in the 3 years prior to incarceration or entering the treatment program.
* No use of an illicit substance, such as only alcohol or marijuana use not in combination with another substance

Contacts and Locations

Study Contact

Jennifer R Bello Kottenstette, MD

CONTACT

314-617-3445

jennifer.bellokottenstette@health.slu.edu

Giulia Croce Butler, MA

CONTACT

314-455-7548

giulia.crocebutler@health.slu.edu

Principal Investigator

Jennifer R Bello Kottenstette, MD

PRINCIPAL_INVESTIGATOR

St. Louis University

Study Locations (Sites)

Buzz Westfall Justice Center

Saint Louis, Missouri, 63105

United States

Collaborators and Investigators

Sponsor: St. Louis University

Jennifer R Bello Kottenstette, MD, PRINCIPAL_INVESTIGATOR, St. Louis University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-12-04

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Substance Use Disorders
Preconception Health
Motivational Interviewing

Additional Relevant MeSH Terms

Substance Use Disorders