Clinical Trials Directory

Trials / Completed

CompletedNCT03735212

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

A Regional Partnership for New York City to Improve Child Welfare Outcomes Among Pregnant Women at Risk of Substance Misuse and Their Newborns

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
405 (actual)
Sponsor
Montefiore Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEnhanced ServicesParticipants receive enhanced services over a period of 6 months to support substance abuse recovery, referral to treatment, and parenting skills.

Timeline

Start date
2019-07-01
Primary completion
2023-07-28
Completion
2023-07-28
First posted
2018-11-08
Last updated
2023-12-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03735212. Inclusion in this directory is not an endorsement.