Clinical trial NCT05746507: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Maternal Drugs Affecting Fetus
Postpartum Mood Disturbance
Sleep Disorder
Neonatal Opioid Withdrawal
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Recruitment and Enrollment
timeFrame: Through study completion up to 3 months
measure: Study Feasibility
timeFrame: Through three months following intervention period
measure: Study Acceptability
timeFrame: Through three months following intervention period
Secondary outcomes:
measure: Maternal sleep quantity
timeFrame: Through three months following intervention
measure: Ability to fall asleep
timeFrame: Through three months following intervention
measure: Sleep quality
timeFrame: Through three months following intervention
measure: Postpartum Sleep Quality
timeFrame: Through three months following intervention
measure: Maternal mental health - Depression
timeFrame: Through three months following intervention
measure: Maternal mental health - Anxiety
timeFrame: Through three months following intervention
measure: Medication for Addiction Treatment Retention
timeFrame: Through three months following intervention
measure: Substance use treatment retention
timeFrame: Through three months following intervention
measure: Recovery Capitol
timeFrame: Through three months following intervention
measure: Parental stress
timeFrame: Through three months following intervention
measure: Parental bonding
timeFrame: Through three months following intervention
measure: Parental self-efficacy
timeFrame: Through three months following intervention
measure: Social Support
timeFrame: Through three months following intervention
measure: Unnecessary unscheduled healthcare utilization
timeFrame: Through three months following intervention
measure: Filings for child abuse/neglect
timeFrame: Through three months following intervention
Other outcomes:
Locations:
city: Mattapan
country: United States
facility: Entre Familia Residential Treatment Program
state: Massachusetts
city: Somerville
country: United States
facility: New Day Residential Treatment Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Davida M Schiff, MD
role: PRINCIPAL_INVESTIGATOR
References: