Regional Partnership for Pregnant Women at Risk of Substance Misuse and Their Newborns

  • STATUS
    Recruiting
  • End date
    Sep 3, 2023
  • participants needed
    270
  • sponsor
    Montefiore Medical Center
Updated on 3 June 2022
Accepts healthy volunteers

Summary

This study recruits pregnant women and new mothers who are at risk of substance use concerns during pregnancy or delivery. These women are followed for 6 months and randomized into two groups; they may receive services as usual, or enhanced services. Enhanced services include evidence based interventions and case management to support referrals to substance abuse treatment, and to teach strategies specifically targeted to parenting newborns.

Description

The dual goals of this project are to (i) improve communication and collaboration between substance abuse treatment providers, obstetricians, and child welfare providers, and (ii) to enhance child welfare outcomes for pregnant women who are at risk of substance misuse and their babies. There is a particular need for a partnership in this area as New York State implements the 2016 Comprehensive Addiction and Recovery Act (CARA) legislation, which focuses on a multi-agency approach to the problem of substance abuse for families at risk of child welfare involvement.

Services are delivered through Montefiore's Department of Obstetrics & Gynecology and Women's Health (Obstetrics). Mothers-to-be who have screened at risk or tested positive for substances will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced prenatal services as part of the program group. Program services include 3 empirically supported interventions: Motivational Enhancement to enhance intrinsic motivation to change unhealthy behaviors and support their referral to substance abuse treatment; Incredible Years to improve parenting skills, especially related to infancy and early childhood; and Contingency Management to reinforce healthy behaviors, including attendance at treatment and abstinence.

Women enrolled into the study are randomly assigned into a program or comparison group. Parent, child, and family outcomes are evaluated using self-report and administrative data.

Details
Condition Substance Use
Treatment Enhanced Services
Clinical Study IdentifierNCT03735212
SponsorMontefiore Medical Center
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The potential subject: (i) is a woman who receives prenatal care at Montefiore Medical
Center, (ii) is at least 16 weeks pregnant and at most 12 weeks post-partum, and (iii) is
identified as at-risk for substance use, and/or has tested positive for at least one
substance

Exclusion Criteria

Minors
Those who are less than 16 weeks pregnant or more than 12 weeks post-partum
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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