Preconception Intervention for Incarcerated Women With Substance Use

NCT05854836 | Recruiting DMC

• 2 other identifiers: 33381K23DA053433
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Substance Use Disorders

Keywords

Substance Use Disorders; Preconception Health; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Number of participants with a change in risk of substance exposed pregnancy compared to baseline using Timeline Followback method assessing substance use and risky sexual behaviors

  Defined as continued drug abstinence, absence of risky sexual behaviors, or both

  one and three months after release from jail

Secondary Outcomes (6)

• Self-efficacy to change substance use

  one and three months after release from jail

• Self-efficacy to change risky sexual behavior

  one and three months after release from jail

• Readiness to change substance use

  one and three months after release from jail

• Readiness to change risky sexual behavior

  one and three months after release from jail

• Decisional balance to change substance use

  one and three months after release from jail

Other Outcomes (2)

• Participant acceptance of and satisfaction with the intervention

  90 days

• Feasibility of delivering the intervention in the 90-day substance use disorder treatment program

  90 days

Study Arms (2)

CHOICES-PLEAS

EXPERIMENTAL

Participants in the experimental arm will receive the motivational interviewing intervention, CHOICES-PLEAS which consists of three one-on-one sessions and one family planning referral visit during incarceration and one booster session at one month after release from jail.

Behavioral: CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)

Control condition

NO INTERVENTION

Participants in the active comparator will receive a control condition that consists of a booklet with general information about healthy lifestyle for women as well as a referral guide to local resources.

Interventions

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

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.

CHOICES-PLEAS

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Participants include individuals who were assigned to the jail-based women's substance use disorder treatment cohort. This determination is made by local judges and can take into account gender expression.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Buzz Westfall Justice Center

St Louis, Missouri, 63105, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jennifer R Bello Kottenstette, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer R Bello Kottenstette, MD

CONTACT

314-617-3445; jennifer.bellokottenstette@health.slu.edu

Phebe Madhusudanan, MD, MPH

CONTACT

314-977-7341; phebe.madhusudanan@health.slu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will randomize the ten 90-day court-mandated substance use disorder treatment cohorts to receive CHOICES-PLEAS (45 women) or brief advice and referral (45 women) over a 2.5 year period using a matching process before randomization to achieve balance between cohorts in the intervention and control groups. Ninety-day cohorts run sequentially. The treatment cohorts will be divided into two cells by program start time within the study period. The first 5 cohorts will be placed in cell one and the second 5 cohorts in cell two. Cohorts will be randomly selected within each of these two cells to be assigned to either the intervention or control group to ensure 5 cohorts will receive CHOICES-PLEAS (9 women per cohort, n=45) and 5 will receive brief advice and referral (9 women per cohort, n=45).

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 11, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (1)