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

NCT04294134 | Enrolling By Invitation

• 1 other identifier: 18-015904
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Parent-Child Relations; Parent Child Abuse

Keywords

Child-parent therapy; Reflective parenting; Trauma-informed care

Outcome Measures

Primary Outcomes (4)

• Change in Infant/Toddler Sensory Profile (ITSP)

  The ITSP provides a standard method for professionals to measure a child's sensory processing abilities and to profile the effect of sensory processing on functional performance in the daily life of a child. This instrument is required as part of the cross-site evaluation. The ITSP is a judgment-based caregiver questionnaire. Each item describes children's responses to various sensory experiences. The ITSP consists of 36 items for children - birth to 6 months - and 48 items for children - 7 to 36 months. The questionnaire is available in English and Spanish. The caregiver questionnaire contains items divided into sensory systems. For children birth to 6 months, there are four quadrant scores and one combined quadrant score; for children 7 to 36 months, there are five sensory processing section scores, four quadrant scores, and one combined quadrant score available.

  Baseline and 9 months

• Change in Infant Traumatic Stress Questionnaire (ITSQ)

  The ITSQ is an 18-item questionnaire based on 3 of the 4 general criteria for diagnosis of Traumatic Stress Disorder in the Diagnostic Classification: 0-3. The ITSQ is used with children under two. For each tool, the three general criteria sampled were "numbing," "increased arousal," and "fears or aggression." The instruments are completed by parents. The participant responds "Yes" or "No" to each question and scores are summed.

  Baseline and 9 months

• Change in Child Traumatic Stress Questionnaire (CTSQ)

  The CTSQ is a 27-item questionnaire based on the criteria for the diagnosis of Traumatic Stress Disorder in the Diagnostic and Statistical Manual of Mental disorders research scale (DSM-IV-RS) and the DC: 0 - 3. The CTSQ with children ages 2 through 4. For each tool, the three general criteria sampled were "numbing," "increased arousal," and "fears or aggression." The instruments are completed by parents. The participant responds "Yes" or "No" to each question and scores are summed.

  Baseline and 9 months

• Change in PSI-SF

  The Parenting Stress Index Short Form (PSI-short form), a 36-item symptom inventory designed to identify parent-child dyads experiencing stress and at risk for dysfunctional parenting and behavior problems. It uses 3 categories: parental distress, parent-child dysfunctional interaction, and difficult child.

  Baseline and 9 months

Secondary Outcomes (10)

• Adult-Adolescent Parenting Inventory (AAPI)

  Baseline and 9 months

• Trauma Symptoms Checklist (TSC-40)

  Baseline and 9 months

• Addiction Severity Index (ASI)

  Baseline and 9 months

• Child Behavior Checklist (CBCL)

  Baseline and 9 months

• Center for Epidemiologic Studies - Depression Scale Short Form (CESD-SF)

  Baseline, 3 months, 6 months, and 9 months

Other Outcomes (1)

• Child welfare involvement

  On year prior to study enrollment and one year following study exit

Study Arms (2)

MIO-CPP

ACTIVE COMPARATOR

The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, 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. The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, 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.

Behavioral: MIO-CPP

MIO-CPP-CRS

EXPERIMENTAL

In Phase 2, participants will receive MIO-CPP therapy, as well as support from a CRS. The MIO-CPP 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. 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.

Behavioral: MIO-CPP-CRS

Interventions

MIO-CPP BEHAVIORAL

Mothering from the Inside Out (MIO) is an individual, 12-session, 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. (Suchman N, Pajulo M, and Mayes LC, 2013). Child-Parent Psychotherapy (CPP) is a two-generation approach that supports and strengthens parent-child attachment by integrating modalities derived from psychodynamic, attachment, trauma, cognitive-behavioral, and social learning theories. (Lieberman AF and Van Horn P, 2005 and 2008) Studies have revealed that CPP caregivers' outcomes include decreased depression, PTSD and other symptoms, increased empathy towards children and an increase in the quality of parent-child interactions. CPP focuses on working with families offering weekly sessions for nine-12 months.

MIO-CPP

MIO-CPP-CRS BEHAVIORAL

Mothering from the Inside Out (MIO) is an individual, 12-session, 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. (Suchman N, Pajulo M, and Mayes LC, 2013). Child-Parent Psychotherapy (CPP) is a two-generation approach that supports and strengthens parent-child attachment by integrating modalities derived from psychodynamic, attachment, trauma, cognitive-behavioral, and social learning theories. (Lieberman AF and Van Horn P, 2005 and 2008) CPP focuses on working with families offering weekly sessions for nine-12 months. Certified Recovery Specialists (CRS) provide peer support services are an evidence-based…model of care which consists of a qualified peer support provider who assists individuals with their recovery from mental illness and substance use disorders.

MIO-CPP-CRS

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Must be at least six months pregnant or must have a child 5 years old or younger.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Health Federation of Philadelphia: collaborator
• Libertae, Inc.: collaborator
• Gaudenzia Hutchinson Place: collaborator
• Gaudenzia Winner Program: collaborator

Study Sites (1)

Roberts Center for Pediatric Research

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Meredith Matone, DrPH, MHS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 3, 2020
• Study Start: January 2, 2020
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified participant data will be available following completion of all study activities for all grantees in the Children's Bureau Regional Partnership Grant (RPG7) in accordance with Child and Family Services Improvement and Innovation Act (Pub. L. 112 34) in order to evaluate grantee performance.
• Access Criteria: Deidentified participant data will be shared with the Children's Bureau, Mathematica Policy Research Institute, and Walter R. McDonald \& Associates (WMRA).

Locations

US (1)