Night Respite for Postpartum Mothers With SUD
- Conditions
- Opioid Use DisorderPostpartum Mood DisturbanceNeonatal Opioid WithdrawalSleep DisorderMaternal Drugs Affecting Fetus
- Interventions
- Behavioral: Night Respite Care
- Registration Number
- NCT05746507
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 35
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Night Respite Care 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
- Primary Outcome Measures
Name Time Method Study Feasibility Through three months following intervention period Count of total number individuals completing intervention and retained through study follow up
Recruitment and Enrollment Through study completion up to 3 months Total number of individuals approached, consented, and enrolled in the study
Study Acceptability Through three months following intervention period Feedback in semi-structured interviews with participants and key stakeholders
- Secondary Outcome Measures
Name Time Method Postpartum Sleep Quality Through three months following intervention Postpartum Sleep Quality Scale
Substance use treatment retention Through three months following intervention Retention in residential treatment program
Ability to fall asleep Through three months following intervention Insomnia Sleep Index (Measured on a scale of 0-28)
Filings for child abuse/neglect Through three months following intervention 51A-filings for child abuse or neglect to MA DCF
Maternal sleep quantity Through three months following intervention Measurement of total nightly sleep using actigraphy device
Sleep quality Through three months following intervention Single Item Sleep Quality Scale;
Maternal mental health - Depression Through three months following intervention Patient Health Questionnaire-8
Maternal mental health - Anxiety Through three months following intervention General Anxiety Disorder-7
Medication for Addiction Treatment Retention Through three months following intervention Continuation of medication for addiction treatment
Recovery Capitol Through three months following intervention Brief Assessment of Recovery Capitol (BARC-10)
Parental stress Through three months following intervention Parenting Stress Index
Parental self-efficacy Through three months following intervention Perceived Parenting Self-Efficacy Questionnaire
Social Support Through three months following intervention Postpartum Social Support Scale
Parental bonding Through three months following intervention Postpartum Bonding Questionnaire;
Unnecessary unscheduled healthcare utilization Through three months following intervention ED and Urgent care visits attended
Trial Locations
- Locations (2)
Entre Familia Residential Treatment Program
🇺🇸Mattapan, Massachusetts, United States
New Day Residential Treatment Program
🇺🇸Somerville, Massachusetts, United States