Night Respite for Postpartum Mothers With SUD

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05746507
Collaborator
(none)
25
2
1
16.3
12.5
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Night Respite Care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
Actual Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Recruitment and Enrollment [Through study completion up to 3 months]

    Total number of individuals approached, consented, and enrolled in the study

  2. Study Feasibility [Through three months following intervention period]

    Count of total number individuals completing intervention and retained through study follow up

  3. Study Acceptability [Through three months following intervention period]

    Feedback in semi-structured interviews with participants and key stakeholders

Secondary Outcome Measures

  1. Maternal sleep quantity [Through three months following intervention]

    Measurement of total nightly sleep using actigraphy device

  2. Ability to fall asleep [Through three months following intervention]

    Insomnia Sleep Index

  3. Sleep quality [Through three months following intervention]

    Single Item Sleep Quality Scale;

  4. Postpartum Sleep Quality [Through three months following intervention]

    Postpartum Sleep Quality Scale

  5. Maternal mental health - Depression [Through three months following intervention]

    Patient Health Questionnaire-8

  6. Maternal mental health - Anxiety [Through three months following intervention]

    General Anxiety Disorder-7

  7. Medication for Addiction Treatment Retention [Through three months following intervention]

    Continuation of medication for addiction treatment

  8. Substance use treatment retention [Through three months following intervention]

    Retention in residential treatment program

  9. Recovery Capitol [Through three months following intervention]

    Brief Assessment of Recovery Capitol (BARC-10)

  10. Parental stress [Through three months following intervention]

    Parenting Stress Index

  11. Parental bonding [Through three months following intervention]

    Postpartum Bonding Questionnaire;

  12. Parental self-efficacy [Through three months following intervention]

    Perceived Parenting Self-Efficacy Questionnaire

  13. Social Support [Through three months following intervention]

    Postpartum Social Support Scale

  14. Unnecessary unscheduled healthcare utilization [Through three months following intervention]

    ED and Urgent care visits attended

  15. Filings for child abuse/neglect [Through three months following intervention]

    51A-filings for child abuse or neglect to MA DCF

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Entre Familia Residential Treatment Program Mattapan Massachusetts United States 02126
2 New Day Residential Treatment Program Somerville Massachusetts United States 02143

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Davida M. Schiff, MD, Assistant Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05746507
Other Study ID Numbers:
  • K23DA048169
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023