Clinical trial NCT04294134: 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
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance Use Disorders
Parent-Child Relations
Parent Child Abuse
Keywords: Child-parent therapy
Reflective parenting
Trauma-informed care
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Health Federation of Philadelphia
name: Libertae, Inc.
name: Gaudenzia Hutchinson Place
name: Gaudenzia Winner Program
First posted: 2020-03-03
Enrollment: 320
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Women actively receiving treatment for Substance Use Disorder at one of three participating residential substance use disorder clinics in Philadelphia and Bucks Counties (Libertae Inc.; Gaudenzia's Hutchinson House; Gaudenzia Winner Program).
2. Must be at least six months pregnant or must have a child 5 years old or younger.
3. Must have access to child - children must either reside with mother, or, if the child is in foster/kinship care, the goal must be reunification.

Exclusion Criteria:

1. Duration of affiliation with treatment center:

   Women will not be referred for enrollment before they have been affiliated with the treatment facility for at least 14 days and will not be referred if they are less than 45 days from discharge.

   These limitations will ensure that women are not referred to our study too quickly as they are adjusting to residential treatment, but will also ensure that we do not enroll women too soon before they are discharged from residential treatment.
2. Non-English Speaking The study will not enroll mothers who would be unable to receive the intervention services in English without the assistance of an interpreter. Due to the duration of the study intervention as well as the frequency of visits between the Child-Parent Specialist and the client, it would not be feasible to ensure that an interpreter would also be available for all visits.

Primary outcomes:
measure: Change in Infant/Toddler Sensory Profile (ITSP)
timeFrame: Baseline and 9 months
measure: Change in Infant Traumatic Stress Questionnaire (ITSQ)
timeFrame: Baseline and 9 months
measure: Change in Child Traumatic Stress Questionnaire (CTSQ)
timeFrame: Baseline and 9 months
measure: Change in PSI-SF
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Adult-Adolescent Parenting Inventory (AAPI)
timeFrame: Baseline and 9 months
measure: Trauma Symptoms Checklist (TSC-40)
timeFrame: Baseline and 9 months
measure: Addiction Severity Index (ASI)
timeFrame: Baseline and 9 months
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline and 9 months
measure: Center for Epidemiologic Studies - Depression Scale Short Form (CESD-SF)
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: PC-PTSD-5
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: Keys to Interactive Parenting (KIPS)
timeFrame: Baseline, 3 months, 6 months, and 9 months
measure: Parenting Relationship Questionnaire (PRQ)
timeFrame: Baseline and 9 months
measure: Parent Development Interview (PDI)
timeFrame: Baseline and 9 months
measure: Pregnancy Interview
timeFrame: Baseline
Other outcomes:
measure: Child welfare involvement
timeFrame: On year prior to study enrollment and one year following study exit
Locations:
city: Philadelphia
country: United States
facility: Roberts Center for Pediatric Research
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Meredith Matone, DrPH, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suchman N, Pajulo M, and Mayes LC, 2013. Parenting and Substance Abuse: Developmental Approaches and Interventions. "Mothering from the Inside Out: A Mentalization-Based Individual Therapy for Mothers with Substance-Use Disorders." Page 407. New York, NY: Oxford University Press.
citation: Lieberman, A. F., & Van Horn, P. (2005). Don't Hit My Mommy! A Manual for Child-Parent Psychotherapy With Young Witnesses of Family Violence. Washington, D.C. : Zero to Three Press.
citation: Lieberman, A. F., & Van Horn, P. (2008). Psychotherapy with Infants and Young Children: Repairing the Effects of Stress and Trauma on Early Attachment. New York: Guilford Press.