CompletedNot Applicable

Night Respite for Postpartum Mothers With SUD

United States41 participantsStarted 2022-12-20

Plain-language summary

This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs.

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: * Caring for an infant under 12 months of age. * Being the primary caretaker for their infant. * Having a DSM-5 diagnosis of a substance use disorder. * Currently residing in a participating residential treatment program or private home setting * English-speaking or Spanish-speakers with limited English proficiency Exclusion Criteria: * Having an untreated serious mental health illness. * Having an untreated substance use disorder or existing concerns that this person is actively using substances. * Having a history of prior violence or intimate partner violence in the home. * Provider concern regarding instability or lack of information about home safety. * Not actively parenting an infant under 12 months of age

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

Recruitment and Enrollment

Timeframe: Through study completion up to 3 months

Study Feasibility

Timeframe: Through three months following intervention period

Study Acceptability

Timeframe: Through three months following intervention period

Trial details

NCT IDNCT05746507

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Opioid Use Disorder trials