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Night help for moms in recovery: can respite care improve sleep and Well-Being?

NCT ID NCT05746507

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tested whether providing overnight infant care and parenting support helps new mothers with substance use disorder living in residential treatment programs. 41 mothers participated, and researchers measured how many enrolled, completed the program, and gave feedback. They also tracked sleep quality and mental health. The goal is to see if this kind of support is feasible and helpful.

What this could mean

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

Active substance
Night respite care (overnight infant care and parenting support)
What this could lead to
If successful, this approach could help improve sleep and mental health for new mothers recovering from substance use disorder.
What could go wrong
This is a small pilot study with only 41 participants and no comparison group, so results may not apply broadly. The intervention is behavioral and may not work for everyone.

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

41 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2025

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: * 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

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome opiate dependence postpartum depression sleep disorder sleep-wake disorder substance-related disorder toxic or drug-related embryofetopathy

As listed by the trial registrant

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

Maternal drugs affecting fetus Neonatal opioid withdrawal Opioid use disorder Postpartum mood disturbance Sleep disorder

Contacts and locations

Locations

  • Entre Familia Residential Treatment Program

    Mattapan, Massachusetts, 02126, United States

  • New Day Residential Treatment Program

    Somerville, Massachusetts, 02143, United States

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