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

NCT03735212 | Completed

• 2 other identifiers: 2018-961190CU-0102-01-00
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (1)

• Change in composite Addiction Severity Index (ASI) score from baseline

  ASI is an assessment tool which will be administered to participants to evaluate their condition in 7 key problem areas of substance use and addiction severity (i.e, medical status, employment, drug use, alcohol use, legal status, family/social status, psychiatric status). Questions generally have a score of 0 of 1 associated. For example, if the patient answers yes, they may score 1; if they answer no, they may score 0. For some items, the scoring may be reversed. 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital. Composite scores will be used to assign a severity rating. The higher the score, the higher the need for treatment.

  Change between Baseline and Follow up (6 month interval)

Study Arms (2)

Program Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in this group receive services as usual.

Interventions

Enhanced Services BEHAVIORAL

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

Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Minors
• Those who are less than 16 weeks pregnant or more than 12 weeks post-partum

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Scott Wetzler, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: July 1, 2019
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)