CompletedNot Applicable

Growing Together: Women in Opioid Treatment and Their Infants

United States60 participantsStarted 2018-12-13

Plain-language summary

This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use * 18 years or older * Being treated with methadone, naltrexone, or suboxone * In 3rd trimester of pregnancy * Deemed by MDs able to give informed consent * Planning to parent infant after birth * Willing to participate in RCT Exclusion Criteria: * Planning to relinquish custody of neonate * Residing, or expected to reside post-birth 20+ miles from Boston * Deemed by MDs unable to give informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Coding Interactive Behavior (CIB) system (Observer-rated parent-infant video), measuring Maternal Sensitivity (representing the parent-child relationship)

Timeframe: t1 (6-8 Weeks postpartum), t2 (6-8 months postpartum)

The Adult- Adolescent Parenting Inventory-2 (AAPI), measuring the Risk of Child Maltreatment

Timeframe: t1 (6-8 weeks postpartum), t2 (6-8 months postpartum), t3 (9-11 months postpartum)

Trial details

NCT IDNCT03866694

SponsorBoston University Charles River Campus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Substance-Related Disorders trials