Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04294134
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-13
First Post:
2020-02-21
Brief Title:
MIO-CPP to Improve the Well-being Permanency and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties and Affected by Maternal Substance Use
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
MIO-CPP to Improve the Well-being Permanency and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties and Affected by Pre and Post-natal Maternal Substance Use
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
The goal of the project is to improve child well-being permanency and safety and reduce the risk for involvement in the child welfare system for families with children pre-birth to five years who are affected by parental substance use disorders SUD The project will integrate with SUD treatment programs for pregnantparenting women and their children and provide an evidence-based therapeutic model Mothering from the Inside Out MIO and Child Parent Psychotherapy CPP MIO-CPP promotes the development of parental reflective functioning and strengthen parentchild attachment The project will also examine the role of Certified Recovery Specialists CRS to provide case management services to parents during their enrollment in therapy
MIO is an individual manualized psychotherapeutic intervention designed to promote parental reflective functioning in mothers who are in treatment for SUDs andor other mental health problems and caring for a child in-utero through five years old CPP is typically offered through weekly sessions with the mother-child dyad that last 1 to 15 hours
The MIO-CPP intervention model will begin with 6 sessions of MIO for each study participant with the CPP assessment and engagement phase embedded during this time This phase will be followed by the dyadic mother-child phase the core intervention stage of CPP If a parent needs additional stabilization more individual time can be added During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents reflective functioning by embedding aspects from MIO
Beginning in Phase 2 participant dyads will be assigned a Certified Recovery Specialists CRSs who will provide services to support them as they transition out of SUD treatment and back into their home communities We will recruit and hire 2 PA CRSs to join the therapeutic team CRS services will include but not be limited to assisting clients with securing housing and employment and connecting to outpatient and other recovery support services eg 12-step programs and child medical and behavioral health care as needed The plan for the timing to introduce CRS services and their issues of focus will be defined through quality improvement methodology during Phase 1
We will use a quasi-experimental trial design with historical controls as well as qualitative interviews to assess effectiveness and efficiency of MIO-CPP when paired with CRS on parent and child outcomes including therapy engagement parentcaregiver well-being child well-being and family well-being The study will take place over two phases Eligible caregivers in Phase 1 will receive MIO-CPP control while participants enrolled in Phase 2 will receive a MIO-CPP while also being paired with a CRS
The recruitment for study participants will stop when 320 mother-child dyads have enrolled in the study Participants will include mother-child dyads from families involved with residential SUD treatment programs serving women and children in Philadelphia and Bucks counties In Bucks County we will receive referrals from Libertae Inc in Bensalem Pennsylvania PA In Philadelphia we will receive referrals from Gaudenzia Hutchinson Place and the Gaudenzia Winner Program
Data collection from participants will occur at four time points during the study 1 when participants are enrolled 2 3 months following enrollment 3 6 months following enrollment and 4 9 months following enrollment or when the participant ends their participation in weekly therapy sessions if sooner than 9 months following enrollment Study measures will include 1 ParentCaregiver Well-being a maternal reflective functioning b depression anxiety and trauma-related symptoms c parental substance use and move toward recovery d parenting stress e parent-child relationship 2 Child Well-being a behavior problems b executive functions c socialization skills 3 Family Well-being a child welfare involvement b reunifications
As part of this study investigator will acquire administrative data about the safety and permanency of children and adult recovery for all study participants The Primary Investigator will request substance use treatment data from the City of Philadelphia Department of Human Services The requested data elements will include whether the study child has a child welfare record the types of allegations of abuse or neglect and when the allegations occurred from birth to present day Additionally investigators will request all available substance use treatment records will be requested for adults who are a part of a study case for the year prior to enrollment in the study to one year following their enrollment in the study
MIO is an individual manualized psychotherapeutic intervention designed to promote parental reflective functioning in mothers who are in treatment for SUDs andor other mental health problems and caring for a child in-utero through five years old CPP is typically offered through weekly sessions with the mother-child dyad that last 1 to 15 hours
The MIO-CPP intervention model will begin with 6 sessions of MIO for each study participant with the CPP assessment and engagement phase embedded during this time This phase will be followed by the dyadic mother-child phase the core intervention stage of CPP If a parent needs additional stabilization more individual time can be added During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents reflective functioning by embedding aspects from MIO
Beginning in Phase 2 participant dyads will be assigned a Certified Recovery Specialists CRSs who will provide services to support them as they transition out of SUD treatment and back into their home communities We will recruit and hire 2 PA CRSs to join the therapeutic team CRS services will include but not be limited to assisting clients with securing housing and employment and connecting to outpatient and other recovery support services eg 12-step programs and child medical and behavioral health care as needed The plan for the timing to introduce CRS services and their issues of focus will be defined through quality improvement methodology during Phase 1
We will use a quasi-experimental trial design with historical controls as well as qualitative interviews to assess effectiveness and efficiency of MIO-CPP when paired with CRS on parent and child outcomes including therapy engagement parentcaregiver well-being child well-being and family well-being The study will take place over two phases Eligible caregivers in Phase 1 will receive MIO-CPP control while participants enrolled in Phase 2 will receive a MIO-CPP while also being paired with a CRS
The recruitment for study participants will stop when 320 mother-child dyads have enrolled in the study Participants will include mother-child dyads from families involved with residential SUD treatment programs serving women and children in Philadelphia and Bucks counties In Bucks County we will receive referrals from Libertae Inc in Bensalem Pennsylvania PA In Philadelphia we will receive referrals from Gaudenzia Hutchinson Place and the Gaudenzia Winner Program
Data collection from participants will occur at four time points during the study 1 when participants are enrolled 2 3 months following enrollment 3 6 months following enrollment and 4 9 months following enrollment or when the participant ends their participation in weekly therapy sessions if sooner than 9 months following enrollment Study measures will include 1 ParentCaregiver Well-being a maternal reflective functioning b depression anxiety and trauma-related symptoms c parental substance use and move toward recovery d parenting stress e parent-child relationship 2 Child Well-being a behavior problems b executive functions c socialization skills 3 Family Well-being a child welfare involvement b reunifications
As part of this study investigator will acquire administrative data about the safety and permanency of children and adult recovery for all study participants The Primary Investigator will request substance use treatment data from the City of Philadelphia Department of Human Services The requested data elements will include whether the study child has a child welfare record the types of allegations of abuse or neglect and when the allegations occurred from birth to present day Additionally investigators will request all available substance use treatment records will be requested for adults who are a part of a study case for the year prior to enrollment in the study to one year following their enrollment in the study
Detailed Description:
None
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