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Preconception Intervention for Incarcerated Women With Substance Use

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion pushed from Dec 31, 2026 to Mar 1, 2027
    • Site contact updated
    v9
  2. Primary completion date: May 31, 2026 to Oct 30, 2026
    • Study completion date: Mar 1, 2027 to Dec 31, 2026
    v8
  3. Primary completion date: Apr 30, 2026 to May 31, 2026
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 53 words
    • Site contact updated
    v7
  4. Primary completion date: Mar 2026 to Apr 30, 2026
    • Study completion date: Mar 2027 to Mar 1, 2027
    v6
  5. Primary completion date: Jun 2026 to Mar 2026
    • Study completion date: Jul 2027 to Mar 2027
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2026 to Jun 2026
    • Site details revised
    v4
  2. Start date: Sep 1, 2023 to Dec 4, 2023v3
  3. Start date: Jul 1, 2023 to Sep 1, 2023
    • Primary completion date: Jan 2026 to Mar 2026
    • Study completion date: Apr 2027 to Jul 2027
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05854836
Lead Sponsor St. Louis University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Substance Use Disorders
Related terms Substance-Related Disorders
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov