Preconception Intervention for Incarcerated Women With Substance Use
ConditionSubstance Use Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorSt. Louis University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)
BehavioralCHOICES-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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: CHOICES-PLEASExperimental treatment 1 intervention
Group B: Control conditionNo intervention 0 interventions
Trial outcomes
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
Time frame
one and three months after release from jailSecondary outcomes
1
Self-efficacy to change substance use
Self-efficacy will be assessed using the single item Abstinence Self-Efficacy scale with scores ranging from 1-10 with higher scores indicating higher confidence.
Time frame
one and three months after release from jail2
Self-efficacy to change risky sexual behavior
Self-efficacy will be assessed using the adapted 18-item Self-efficacy for Birth Control and Condom Use Scale with scores 18 - 90, with higher scores indicating higher confidence.
Time frame
one and three months after release from jail3
Readiness to change substance use
Readiness to change will be assessed using the adapted 12-item Readiness to Change Questionnaire for substance use with scores from 12 to 60 with higher scores indicating higher levels of readiness.
Time frame
one and three months after release from jail4
Readiness to change risky sexual behavior
Readiness to change will be assessed using the adapted 11-item Readiness to Change Questionnaire for risky sexual behaviors with scores from 11 to 55 with higher scores indicating higher levels of readiness
Time frame
one and three months after release from jailOther outcomes
1
Participant acceptance of and satisfaction with the intervention
Measured using the 8-item Client Satisfaction Questionnaire (CSQ-8) with scores ranging from 8 to 32, with higher numbers indicating greater satisfaction. Five open ended questions about the intervention will also be administered.
Time frame
90 days2
Feasibility of delivering the intervention in the 90-day substance use disorder treatment program
Feasibility will be measured using the Working-Alliance Inventory measure. Twelve items are answered by the participant and 12 items are answered by the therapist. Scores for each 12-item subscale range from 12 to 84 with higher scores indicating greater therapeutic alliance.
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Louis University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov