RecruitingNot ApplicableNCT05854836

Preconception Intervention for Incarcerated Women With Substance Use

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

Sponsor

St. Louis University

Enrollment

90 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

Substance Use Disorders

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Inclusion Criteria5

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).
(For women recruited from the MAT Program): Expected length of incarceration at the St. Louis County Jail 2-6 months; expected release into the community.

Exclusion Criteria5

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

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Interventions

BEHAVIORALCHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)

CHOICES-PLEAS includes four manual-guided motivational interviewing sessions delivered by a trained counselor and one family planning counseling session delivered by a family planning clinician. The intervention is based on the Transtheoretical Model (TTM) of behavior change and motivational interviewing that includes a decisional balance exercise, goal self-selection, self-monitoring, self-generated plans, and importance and confidence scales. By using a patient-centered approach based on the TTM that meets patients where they are, counselors can have a more effective impact on patient behaviors. This adaptation from the original CHOICES intervention contains unique features focused on the incarcerated setting, illicit polysubstance use, and risky sexual behaviors most common among women with illicit polysubstance use.