Night Respite for Postpartum Mothers With SUD

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746507
• Other study ID #: K23DA048169
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Davida M Schiff, MD
• Phone: 617-643-6631
• Email: davida.schiff[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Opioid Withdrawal
• Opioid Use Disorder
• Opioid-Related Disorders
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• Night Respite Care
(see description above)

Locations

Country	Name	City	State
United States	Entre Familia Residential Treatment Program	Mattapan	Massachusetts
United States	New Day Residential Treatment Program	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and Enrollment	Total number of individuals approached, consented, and enrolled in the study	Through study completion up to 3 months
Primary	Study Feasibility	Count of total number individuals completing intervention and retained through study follow up	Through three months following intervention period
Primary	Study Acceptability	Feedback in semi-structured interviews with participants and key stakeholders	Through three months following intervention period
Secondary	Maternal sleep quantity	Measurement of total nightly sleep using actigraphy device	Through three months following intervention
Secondary	Ability to fall asleep	Insomnia Sleep Index (Measured on a scale of 0-28)	Through three months following intervention
Secondary	Sleep quality	Single Item Sleep Quality Scale;	Through three months following intervention
Secondary	Postpartum Sleep Quality	Postpartum Sleep Quality Scale	Through three months following intervention
Secondary	Maternal mental health - Depression	Patient Health Questionnaire-8	Through three months following intervention
Secondary	Maternal mental health - Anxiety	General Anxiety Disorder-7	Through three months following intervention
Secondary	Medication for Addiction Treatment Retention	Continuation of medication for addiction treatment	Through three months following intervention
Secondary	Substance use treatment retention	Retention in residential treatment program	Through three months following intervention
Secondary	Recovery Capitol	Brief Assessment of Recovery Capitol (BARC-10)	Through three months following intervention
Secondary	Parental stress	Parenting Stress Index	Through three months following intervention
Secondary	Parental bonding	Postpartum Bonding Questionnaire;	Through three months following intervention
Secondary	Parental self-efficacy	Perceived Parenting Self-Efficacy Questionnaire	Through three months following intervention
Secondary	Social Support	Postpartum Social Support Scale	Through three months following intervention
Secondary	Unnecessary unscheduled healthcare utilization	ED and Urgent care visits attended	Through three months following intervention
Secondary	Filings for child abuse/neglect	51A-filings for child abuse or neglect to MA DCF	Through three months following intervention