Night Respite for Postpartum Mothers With SUD

Last updated: March 26, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Insomnia

Opioid Use Disorder

Restless Leg Syndrome

Treatment

Night Respite Care

Clinical Study ID

NCT05746507
K23DA048169
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 homesetting

  • English-speaking or Spanish-speakers with limited English proficiency

Exclusion

Exclusion Criteria:

  • Having an untreated serious mental health illness.

  • Having an untreated substance use disorder or existing concerns that this person isactively 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

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Night Respite Care
Phase:
Study Start date:
December 20, 2022
Estimated Completion Date:
April 30, 2025

Study Description

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.

Connect with a study center

  • Entre Familia Residential Treatment Program

    Mattapan, Massachusetts 02126
    United States

    Site Not Available

  • New Day Residential Treatment Program

    Somerville, Massachusetts 02143
    United States

    Site Not Available

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