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Home-Based parenting program aims to strengthen bonds for mothers in recovery

NCT ID NCT03866694

Disease control Sponsor: Boston University Charles River Campus Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests a home-based parenting program called BRIGHT for pregnant women receiving treatment for opioid use disorder. The program starts in the third trimester and continues for six months after birth, focusing on the parent-child relationship, mental health, and infant development. Half of the 60 participants receive BRIGHT plus standard care; the other half receive only handouts and standard care. Researchers will measure changes in parent-child interaction and parenting attitudes to see if the program reduces the risk of child maltreatment and improves family well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a home-based therapeutic parenting intervention called BRIGHT, plus monthly handouts and standard care
What this could lead to
If effective, this program could provide a scalable way to support mothers in recovery and improve outcomes for their infants.
What could go wrong
This is a small early-stage trial with 60 participants, so results may not apply broadly. The intervention is behavioral and effects may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Dec 2018

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

opiate dependence Psychological Well-Being substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Substance-related disorders

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

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