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Night Respite for Postpartum Mothers With SUD

Primary Purpose

Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Night Respite Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • Entre Familia Residential Treatment ProgramRecruiting
  • New Day Residential Treatment ProgramRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Night Respite Care

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment and Enrollment
Total number of individuals approached, consented, and enrolled in the study
Study Feasibility
Count of total number individuals completing intervention and retained through study follow up
Study Acceptability
Feedback in semi-structured interviews with participants and key stakeholders

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2023
Last Updated
February 25, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05746507
Brief Title
Night Respite for Postpartum Mothers With SUD
Official Title
Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder, Neonatal Opioid Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Night Respite Care
Arm Type
Experimental
Arm Description
18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports
Intervention Type
Behavioral
Intervention Name(s)
Night Respite Care
Intervention Description
(see description above)
Primary Outcome Measure Information:
Title
Recruitment and Enrollment
Description
Total number of individuals approached, consented, and enrolled in the study
Time Frame
Through study completion up to 3 months
Title
Study Feasibility
Description
Count of total number individuals completing intervention and retained through study follow up
Time Frame
Through three months following intervention period
Title
Study Acceptability
Description
Feedback in semi-structured interviews with participants and key stakeholders
Time Frame
Through three months following intervention period
Secondary Outcome Measure Information:
Title
Maternal sleep quantity
Description
Measurement of total nightly sleep using actigraphy device
Time Frame
Through three months following intervention
Title
Ability to fall asleep
Description
Insomnia Sleep Index
Time Frame
Through three months following intervention
Title
Sleep quality
Description
Single Item Sleep Quality Scale;
Time Frame
Through three months following intervention
Title
Postpartum Sleep Quality
Description
Postpartum Sleep Quality Scale
Time Frame
Through three months following intervention
Title
Maternal mental health - Depression
Description
Patient Health Questionnaire-8
Time Frame
Through three months following intervention
Title
Maternal mental health - Anxiety
Description
General Anxiety Disorder-7
Time Frame
Through three months following intervention
Title
Medication for Addiction Treatment Retention
Description
Continuation of medication for addiction treatment
Time Frame
Through three months following intervention
Title
Substance use treatment retention
Description
Retention in residential treatment program
Time Frame
Through three months following intervention
Title
Recovery Capitol
Description
Brief Assessment of Recovery Capitol (BARC-10)
Time Frame
Through three months following intervention
Title
Parental stress
Description
Parenting Stress Index
Time Frame
Through three months following intervention
Title
Parental bonding
Description
Postpartum Bonding Questionnaire;
Time Frame
Through three months following intervention
Title
Parental self-efficacy
Description
Perceived Parenting Self-Efficacy Questionnaire
Time Frame
Through three months following intervention
Title
Social Support
Description
Postpartum Social Support Scale
Time Frame
Through three months following intervention
Title
Unnecessary unscheduled healthcare utilization
Description
ED and Urgent care visits attended
Time Frame
Through three months following intervention
Title
Filings for child abuse/neglect
Description
51A-filings for child abuse or neglect to MA DCF
Time Frame
Through three months following intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female-identifying individuals living in residential treatment programs
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davida M Schiff, MD
Phone
617-643-6631
Email
davida.schiff@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davida M Schiff, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Entre Familia Residential Treatment Program
City
Mattapan
State/Province
Massachusetts
ZIP/Postal Code
02126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Shoaf Kozak, PhD, LICSW, MPH
Email
RShoafKozak@bphc.org
Facility Name
New Day Residential Treatment Program
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Cichowlas
Email
scichowlas@baycove.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Night Respite for Postpartum Mothers With SUD

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