Night Respite for Postpartum Mothers With SUD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder, Neonatal Opioid Withdrawal

Intervention / Treatment
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* Behavioral: Night Respite Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Night Respite Care<br>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<br>* (see description above)<br>|

What is the study measuring?
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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 | 
| Ability to fall asleep | Insomnia Sleep Index | 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 |