Regional Partnership for Pregnant Women at Risk of Substance Misuse and Their Newborns
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Addiction Severity Index [Change is being assessed between Baseline and Follow up (6 month interval)]
A measure of substance use and addiction severity
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Scott Wetzler, MD, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-9611
- 90CU-0102-01-00