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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03735212
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : June 5, 2020
Information provided by (Responsible Party):
Scott Wetzler, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Enhanced Services Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Experimental: Program Group
Participants in this group receive enhanced services as the intervention. These services include Motivational Enhancement, Incredible Years, and Contingency Management. Participants also receive case management services to support referrals to substance use.
Behavioral: Enhanced Services
Participants receive enhanced services over a period of 6 months to support substance abuse recovery, referral to treatment, and parenting skills.

No Intervention: Control Group
Participants in this group receive services as usual.

Primary Outcome Measures :
  1. Addiction Severity Index [ Time Frame: Change is being assessed between Baseline and Follow up (6 month interval) ]
    A measure of substance use and addiction severity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03735212

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Contact: Alessandra DeMarchena, LCSW 718-401-5050
Contact: Anita Jose, PhD 718-401-5050

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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Alessandra Demarchena, LCSW    718-401-5050   
Contact: Anita Jose, PhD    718-401-5050   
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Scott Wetzler, MD Montefiore Medical Center
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Responsible Party: Scott Wetzler, Attending Psychologist, Montefiore Medical Center Identifier: NCT03735212    
Other Study ID Numbers: 2018-9611
90CU-0102-01-00 ( Other Grant/Funding Number: New York Children's Bureau )
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No