Substance UseNCT03735212
Regional Partnership for Pregnant Women at Risk of Substance Misuse and Their Newborns
A study testing Enhanced Services in people with Substance Use, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Enhanced Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- Minors
- Those who are less than 16 weeks pregnant or more than 12 weeks post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Enhanced Services
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced ServicesBehavioural
Participants receive enhanced services over a period of 6 months to support substance abuse recovery, referral to treatment, and parenting skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Enhanced Services |
| Control Group | No intervention | Participants in this group receive services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between Baseline and Follow up (6 month interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jul 2019
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Wetzler, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735212
- Sponsor's protocol ID
- 2018-9611
- Other IDs
- 90CU-0102-01-00
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2018
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03735212
- Acronym / sponsor ID
- 2018-9611
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program Group | Experimental | Behavioral: Enhanced ServicesParticipants 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. |
| Control Group | No intervention | –Participants in this group receive services as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (2 listed)
- Minors
- Those who are less than 16 weeks pregnant or more than 12 weeks post-partum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced ServicesParticipants receive enhanced services over a period of 6 months to support substance abuse recovery, referral to treatment, and parenting skills. | Behavioural | Program Group |
Primary outcome
Change in composite Addiction Severity Index (ASI) score from baseline
Time frame: Change between Baseline and Follow up (6 month interval)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data with other researchers.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Wetzler, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Services in people with Substance Use, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite Addiction Severity Index (ASI) score from baseline (time frame: Change between Baseline and Follow up (6 month interval)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.