Clinical trial NCT03735212: Regional Partnership for Pregnant Women at Risk of Substance Misuse and Their Newborns
Official title: A Regional Partnership for New York City to Improve Child Welfare Outcomes Among Pregnant Women at Risk of Substance Misuse and Their Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 405
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in composite Addiction Severity Index (ASI) score from baseline
timeFrame: Change between Baseline and Follow up (6 month interval)
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Scott Wetzler, MD
role: PRINCIPAL_INVESTIGATOR
References: