Night Respite for Postpartum Mothers With SUD

NCT ID: NCT05746507

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) to each of 20 - 25 mothers with substance use disorders in the early postpartum period residing in residential substance use disorder treatment programs. Overnight respite care will last for eight hours, with one hour reserved each morning to provide teaching about infant-specific temperament and cues. The program is a unique public/private/academic partnership with the Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), two residential treatment programs, and Massachusetts General Hospital.

Partnering with BBNN, Newborn Care Experts interested in providing respite care to families impacted by SUD will be paired with postpartum families residing in two residential treatment programs in the Boston area. New Day in Somerville, MA and Entre Familia in Mattapan, MA will partner with MGH to recruit individuals to complete a screening and baseline intake, receive night respite care, and complete a follow up study visit at the completion of the intervention and at 3 months post intervention.

This study will use mixed methods to understand the feasibility and acceptability of the pilot intervention including experiences of this pilot program through the perspectives of program participants, respite care givers, residential treatment overnight staff, and study staff. Respite caregivers and residential treatment program staff will be invited to participate in interviews after each dyad receives their allotted hours of respite care to reflect on this program participant's specific experience.

BBNN, DCF, and residential treatment program leadership staff, will be invited to participate a focus group once at the completion of the study to understand the feasibility, acceptability, and implementation of this program through the lens of their organizations. They will also be invited to take a short survey aimed at assessing their perception of the intervention's appropriateness and feasibility.

Conditions

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Opioid Use Disorder Maternal Drugs Affecting Fetus Postpartum Mood Disturbance Sleep Disorder Neonatal Opioid Withdrawal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Overnight infant respite care provided approximately 3 nights per week for 6 weeks (18 nights total) lasting eight hours per night. Overnight respite care will last for eight hours, with one hour reserved to provide teaching about infant-specific temperament and cues.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Night Respite Care

18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports

Group Type EXPERIMENTAL

Night Respite Care

Intervention Type BEHAVIORAL

(see description above)

Interventions

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Night Respite Care

(see description above)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Davida M. Schiff, MD

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davida M Schiff, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Entre Familia Residential Treatment Program

Mattapan, Massachusetts, United States

Site Status

New Day Residential Treatment Program

Somerville, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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K23DA048169

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P001377

Identifier Type: -

Identifier Source: org_study_id

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