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.|
|ClinicalTrials.gov Identifier: NCT03735212|
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Substance Use||Behavioral: Enhanced Services||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03735212
|Contact: Alessandra DeMarchena, LCSWfirstname.lastname@example.org|
|Contact: Anita Jose, PhDemail@example.com|
|Principal Investigator:||Scott Wetzler, MD||Montefiore Medical Center|