Night Respite Care
Behavioral(see description above)
NCT Number: NCT05746507
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Entre Familia Residential Treatment Program, Mattapan, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(see description above)
Time frame: Through study completion up to 3 months
Total number of individuals approached, consented, and enrolled in the study
Time frame: Through three months following intervention period
Count of total number individuals completing intervention and retained through study follow up
Time frame: Through three months following intervention period
Feedback in semi-structured interviews with participants and key stakeholders
Time frame: Through three months following intervention
Measurement of total nightly sleep using actigraphy device
Time frame: Through three months following intervention
Insomnia Sleep Index (Measured on a scale of 0-28)
Time frame: Through three months following intervention
Single Item Sleep Quality Scale;
Time frame: Through three months following intervention
Postpartum Sleep Quality Scale
Time frame: Through three months following intervention
Patient Health Questionnaire-8
Time frame: Through three months following intervention
General Anxiety Disorder-7
Time frame: Through three months following intervention
Continuation of medication for addiction treatment
Time frame: Through three months following intervention
Retention in residential treatment program
Time frame: Through three months following intervention
Brief Assessment of Recovery Capitol (BARC-10)
Time frame: Through three months following intervention
Parenting Stress Index
Time frame: Through three months following intervention
Postpartum Bonding Questionnaire;
Time frame: Through three months following intervention
Perceived Parenting Self-Efficacy Questionnaire
Time frame: Through three months following intervention
Postpartum Social Support Scale
Time frame: Through three months following intervention
ED and Urgent care visits attended
Time frame: Through three months following intervention
51A-filings for child abuse or neglect to MA DCF
Massachusetts General Hospital
Other
Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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