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MIO-CPP for Parental Substance Use Disorders Impact on Children

N/A
Waitlist Available
Led By Meredith Matone, DrPH, MHS
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be at least six months pregnant or must have a child 5 years old or younger
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on year prior to study enrollment and one year following study exit
Awards & highlights

Study Summary

This trial will study whether the MIO-CPP model is more effective than CPP in reducing the risk for involvement in the child welfare system, improving child well-being, and permanency and safety for children pre-birth to five who are affected by parental substance use disorders (SUD) and/or other mental health problems.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Mothering from the Inside Out (MIO) combined with Child Parent Psychotherapy (CPP), aiming to improve parent-child relationships and reduce child welfare system involvement. Phase 1 participants receive MIO-CPP only, while Phase 2 also includes support from Certified Recovery Specialists (CRS).See study design
What are the potential side effects?
Since this intervention involves therapy sessions rather than medication, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional discomfort as they work through personal and parenting challenges during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least six months pregnant or have a child under 5 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on year prior to study enrollment and one year following study exit
This trial's timeline: 3 weeks for screening, Varies for treatment, and on year prior to study enrollment and one year following study exit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Child Traumatic Stress Questionnaire (CTSQ)
Change in Infant Traumatic Stress Questionnaire (ITSQ)
Change in Infant/Toddler Sensory Profile (ITSP)
+1 more
Secondary outcome measures
Addiction Severity Index (ASI)
Adult-Adolescent Parenting Inventory (AAPI)
Center for Epidemiologic Studies - Depression Scale Short Form (CESD-SF)
+6 more
Other outcome measures
Child welfare involvement

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MIO-CPP-CRSExperimental Treatment1 Intervention
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.
Group II: MIO-CPPActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,173 Total Patients Enrolled
Libertae, Inc.UNKNOWN
Health Federation of PhiladelphiaUNKNOWN

Media Library

MIO-CPP Clinical Trial Eligibility Overview. Trial Name: NCT04294134 — N/A
Substance Use Disorder Research Study Groups: MIO-CPP, MIO-CPP-CRS
Substance Use Disorder Clinical Trial 2023: MIO-CPP Highlights & Side Effects. Trial Name: NCT04294134 — N/A
MIO-CPP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294134 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main objective of this experiment?

"This clinical trial's primary outcome, which will be evaluated between Baseline and 9 months, is to assess Change in ITSQ. Secondary goals include employing the PRQ (Parenting Relationship Questionnaire) assessment for parents of 2-5 year olds over a 10-15 minute window; utilizing the CESD-SF (Center for Epidemiological Studies Depression Scale - Short Form) tool for a self or interviewer administered questionnaire with less than ten minutes completion time; and administering PDI (Parent Development Interview), an interactive 45 item semi-structured interview to examine parent representations of their child, themselves as parents, and relationships with said children."

Answered by AI

Are individuals presently being enrolled for this research endeavor?

"According to clinicaltrials.gov, enrollment for this specific medical trial has been closed since March 23rd 2022 - when it was last updated. Yet, there are currently 416 other trials open and actively seeking patients."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294134.
~56 spots leftby Jun 2027
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