- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700696
Enhancing Permanency in Children and Families (EPIC)
Study Overview
Status
Conditions
Detailed Description
Funded by the federal Regional Partnership Grant (RPG) Program, the Enhancing Permanency in Children and Families (EPIC) is a partnership between child welfare, juvenile count and behavioral health to holistically address substance misuse and associated parenting needs of child welfare-involved families. The overall goals and objectives of the intervention are to 1) Increase timely access to services among substances abusing parents involved in the child welfare system in Fairfield and Pickaway counties, 2.Enhance child safety and improve permanency and 3. increase child, parent, and caregiver well-being.
Eligible participants are matched with peer recovery supporters who mentor parents through the process. Parents are also referred to Family Treatment Drug Court (FTDC) with the option to receive Medications for Opioid Use Disorders (MOUD), and lastly when children are placed at home with parents or with kinship caregivers, relational skill building services that include financial assistance for child care, respite and transportation services. EPIC participants receive substance abuse and behavioral health treatment services through local providers including from two partner agencies: Integrated Services for Behavioral Health and Ohio Guidestone.
Data collection: Participating parents complete a pretest at baseline and up to 5 post-tests at 6 month intervals. Parents complete questions related to themselves (e.g. Addiction Severity Index, CES-D) and for one focal child (e.g. CBCL).
To evaluate EPIC, a quasi-experimental design will be employed through a two-stage sampling procedure. This design provides the ability to assess (1) the effects of EPIC on access to services for the families in the two intervention counties, and (2) the independent effects of additional services provided under EPIC that may be over and above Ohio START (an intervention administered through the Public Children Services Association of Ohio) and treatment as usual (TAU). In the first stage, two comparison counties will be identified for each of the two intervention counties. One comparison county will be part of the Ohio START program while the second will be a county that has no major interventions to address substance use among child welfare families. Counties are matched based on child population size, rate of child protective services referrals, percent of naloxone administrations per adult population, percent white, percent poverty, child welfare tax levy, and to the extent possible, behavioral health service availability. During the second stage, EPIC families are matched with substance using families in each of the comparison counties.
Parents may consent to one or all three components of EPIC based on the specific needs of each family, however all parents receive intensive case management services, including frequent home visits from caseworkers and peer recovery supporters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child welfare involvement
- Substance use is primary reason for child welfare involvement (a score or 3 or more on UNCOPE assessment or a positive drug screen)
Exclusion Criteria:
- Possible substance use, though not primary reason for child welfare involvement
- incarcerated parents (may enroll after release)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EPIC Participants
EPIC participants are 1) matched with trained peer recovery supporters with lived experience related to child welfare and substance EPIC participants are also incentivized to participate in 2) family treatment drug court (FTDC), with medications for opioid use disorders (MOUD); and 3) home-based parenting supports based on the Nurturing Parenting Program.
|
Weekly visits with peer who has lived experience related to child welfare and addiction
Incentivized to participate in Family Treatment Drug Court with option for Medications for Opioid Use Disorders (MOUD)
Home-based parenting support
|
|
Active Comparator: Ohio Sobriety Treatment And Reducing Trauma (START) participants
Adapted from the evidence-based national START model (Sobriety Treatment and Recovery Teams) this intervention matches child welfare parents in need of addiction services to caseworker and family peer mentor (FPM) dyads for intensive case management services.
|
Weekly visits with peer who has lived experience related to child welfare and addiction
|
|
No Intervention: Treatment as usual (TAU)
Treatment as usual includes home visits by the assigned caseworker, referrals to SUD assessment/treatment, family group decision making, and (non-incentivized) referral to FTDC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time from opening of child welfare case to SUD screening
Time Frame: Within 30 days of program entry
|
Measures: 1) Child welfare case open date; 2) UNCOPE assessment screening date Analyses: We will use T-tests to estimate mean differences in the length of time from entry into child welfare and SUD screening for EPIC participants in comparison to Ohio START and treatment as usual.
|
Within 30 days of program entry
|
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Time from opening of child welfare case to trauma screening
Time Frame: Within 30 days of program entry
|
Measures: Time from opening of child welfare case to trauma screening will be estimated using 1) child welfare case open date; 2) ACEs assessment date for adults or 3) CTAC assessment dates for children. Analyses: We will use t-tests to estimate mean differences in the length of time from entry into child welfare and trauma screening for EPIC participants in comparison to Ohio START and treatment as usual. |
Within 30 days of program entry
|
|
Change in wait time between referral to addiction treatment services and initiation of services.
Time Frame: Within 30 days of entering child welfare system
|
Measures: Change in wait time will be estimated using service referral and service initiation dates. Analyses: We will use t-tests to estimate mean differences in the length of time between SUD treatment service referral and service initiation for EPIC participants in comparison to Ohio START and treatment as usual. |
Within 30 days of entering child welfare system
|
|
Change in addiction severity among participating parents
Time Frame: At program entry and again at program completion. An average of I year
|
Measures: Addiction Severity Index-Self Report (ASI-SR) Analyses: A paired sample t-test will be conducted to examine the change in mean scores on the ASI-SR pre and post participation.
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At program entry and again at program completion. An average of I year
|
|
Change in resilience in children
Time Frame: At program entry and again at program completion. An average of I year
|
Measures: Resilience in children is measured using the Protective Factors Survey (PFS) Analyses: A paired sample t-test will be conducted to examine change in mean scores on the PFS pre and post participation.
|
At program entry and again at program completion. An average of I year
|
|
Change in child behavior
Time Frame: At program entry and again at program completion. An average of I year
|
Measures: The Child Behavior Checklist (CBCL) is used to screen for emotional, behavioral and social problems among children. Analyses: A paired sample t-test will be conducted to examine change in mean scores on the CBCL pre and post participation. |
At program entry and again at program completion. An average of I year
|
|
Change length of stay in out-of-home placement for children in EPIC program compared to substance-affected families not receiving EPIC.
Time Frame: Through program completion, an average of 1 year.
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Data source: Statewide Automated Child Welfare Information System (SACWIS), obtained twice a year through study completion. Measures: Length of stay in out-of-home placement will be operationalized using placement dates obtained in SACWIS. Analyses: Survival analysis will be utilized to study outcome measures (e.g., length of stay in out-of-home placement) Due to the likelihood of censored measures when we have families who are still involved in the child welfare system, particularly for families who enter the system near the end of the study period, we will use survival analysis to estimate treatment effects on length of stay in out of home placement in comparison to Ohio START and treatment as usual families. |
Through program completion, an average of 1 year.
|
|
Change in reunification among families involved in EPIC compared to substance-affected families not receiving EPIC.
Time Frame: Through program completion, an average of 1 year.
|
Data source: Statewide Automated Child Welfare Information System (SACWIS), obtained twice a year through study completion. Analyses: Logistic regression will be used to estimate treatment effects on in comparison to Ohio START and treatment as usual. |
Through program completion, an average of 1 year.
|
|
Change in subsequent child welfare involvement among parents receiving EPIC compared to substance-affected families not receiving EPIC
Time Frame: Through completion of 5 year study. For participants, up to 4 years following program participation, depending on time of enrollment
|
Data source: Statewide Automated Child Welfare Information System (SACWIS), obtained twice a year through study completion. Measures: Subsequent child welfare entry (yes/no) is measured using re-entry dates in SACWIS. Analyses: Logistic regressions will be used to estimate treatment effects on subsequent child welfare involvement in comparison to Ohio START and treatment as usual. |
Through completion of 5 year study. For participants, up to 4 years following program participation, depending on time of enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bridget Freisthler, Ohio State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90CU0083-01-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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