Night Respite for Postpartum Mothers With SUD

Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Opioid Use Disorder; Neonatal Opioid Withdrawal; Maternal Drugs Affecting Fetus; Postpartum Mood Disturbance
• Intervention / Treatment: Behavioral: Night Respite Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davida M Schiff, MD; Phone Number: 617-643-6631; Email: davida.schiff@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Mattapan, Massachusetts, United States, 02126
      • Recruiting
      • Entre Familia Residential Treatment Program
      • Contact: Rebecca Shoaf Kozak, PhD, LICSW, MPH; Email: RShoafKozak@bphc.org
    • Somerville, Massachusetts, United States, 02143
      • Recruiting
      • New Day Residential Treatment Program
      • Contact: Shelly Cichowlas; Email: scichowlas@baycove.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Night Respite Care; (see description above)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and Enrollment	Total number of individuals approached, consented, and enrolled in the study	Through study completion up to 3 months
Study Feasibility	Count of total number individuals completing intervention and retained through study follow up	Through three months following intervention period
Study Acceptability	Feedback in semi-structured interviews with participants and key stakeholders	Through three months following intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal sleep quantity	Measurement of total nightly sleep using actigraphy device	Through three months following intervention
Sleep quality	Single Item Sleep Quality Scale;	Through three months following intervention
Postpartum Sleep Quality	Postpartum Sleep Quality Scale	Through three months following intervention
Maternal mental health - Depression	Patient Health Questionnaire-8	Through three months following intervention
Maternal mental health - Anxiety	General Anxiety Disorder-7	Through three months following intervention
Medication for Addiction Treatment Retention	Continuation of medication for addiction treatment	Through three months following intervention
Substance use treatment retention	Retention in residential treatment program	Through three months following intervention
Recovery Capitol	Brief Assessment of Recovery Capitol (BARC-10)	Through three months following intervention
Parental stress	Parenting Stress Index	Through three months following intervention
Parental bonding	Postpartum Bonding Questionnaire;	Through three months following intervention
Parental self-efficacy	Perceived Parenting Self-Efficacy Questionnaire	Through three months following intervention
Social Support	Postpartum Social Support Scale	Through three months following intervention
Unnecessary unscheduled healthcare utilization	ED and Urgent care visits attended	Through three months following intervention
Filings for child abuse/neglect	51A-filings for child abuse or neglect to MA DCF	Through three months following intervention
Ability to fall asleep	Insomnia Sleep Index (Measured on a scale of 0-28)	Through three months following intervention

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Davida M Schiff, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Nervous System Diseases; Substance-Related Disorders; Neurologic Manifestations; Narcotic-Related Disorders; Sleep Wake Disorders; Opioid-Related Disorders
• Other Study ID Numbers: K23DA048169 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No