MIO-CPP for Parental Substance Use Disorders Impact on Children
Trial Summary
What is the purpose of this trial?
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 pregnant/parenting 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 parent/child 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 and/or 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 1.5 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 (e.g. 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, parent/caregiver 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) Parent/Caregiver 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.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the MIO-CPP treatment for parental substance use disorders?
The MIO (Mothering from the Inside Out) component of the treatment has shown some effectiveness in improving parenting behaviors and reducing depression in mothers with substance use disorders, although its effectiveness was less when delivered by community-based clinicians compared to research clinicians. This suggests that MIO-CPP might help improve parenting and child outcomes in families affected by substance use disorders.12345
How is the MIO-CPP treatment different from other treatments for parental substance use disorders?
MIO-CPP (Mothering from the Inside Out - Child-Parent Psychotherapy) is unique because it focuses on improving parenting skills specifically for mothers with substance use disorders by addressing the emotional needs of children and the mothers' own histories of adversity. This approach integrates addiction treatment with parenting support, which is not commonly addressed in standard programs.26789
Research Team
Meredith Matone, DrPH, MHS
Principal Investigator
Children's Hospital of Philadelphia
Eligibility Criteria
This trial is for mothers in Philadelphia and Bucks Counties who are receiving treatment for Substance Use Disorder at specified clinics, are at least six months pregnant or have a child under five years old. The children must live with the mother or be on track to reunify if currently in foster care. Mothers must speak English without needing an interpreter.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
MIO-CPP Intervention
Participants receive 12 weeks of MIO with CPP assessment and engagement phase embedded, followed by the dyadic mother-child phase of CPP.
CRS Support
Participants in Phase 2 receive support from Certified Recovery Specialists (CRS) to assist with transition out of SUD treatment and back into their home communities.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collection at multiple time points.
Treatment Details
Interventions
- CPP-only
- MIO-CPP
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Health Federation of Philadelphia
Collaborator
Libertae, Inc.
Collaborator
Health Federation of Philadelphia
Collaborator
Gaudenzia Hutchinson Place
Collaborator
Gaudenzia Winner Program
Collaborator
Interim House West
Collaborator
The Caring Together Program
Collaborator
The Neonatal Follow-up Program at Children's Hospital of Philadelphia
Collaborator
Penn Family Care
Collaborator