Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05746507
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-02-15
Brief Title:
Night Respite for Postpartum Mothers With SUD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Feasibility of Night Respite Care for Postpartum Mothers With Substance Use Disorder in Residential Treatment Programs
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 publicprivateacademic 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 participants 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 interventions appropriateness and feasibility
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 participants 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 interventions appropriateness and feasibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None