Enhancing Permanency in Children and Families (EPIC)

January 19, 2024 updated by: Ohio State University
The Enhancing Permanency in Children and Families (EPIC) program is a collaborative effort between the Ohio State University College of Social Work, two county offices of the Ohio Department of Job and Family Services, two juvenile courts and local behavioral health agencies. The goal of EPIC is to use three evidence-based and evidence-informed practices to reduce abusive and neglectful parenting, reduce addiction severity in parents, and improve permanency outcomes for families involved with the child welfare system due to substance abuse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Peer Recovery Support
Weekly visits with peer who has lived experience related to child welfare and addiction
Behavioral: Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)
Incentivized to participate in Family Treatment Drug Court with option for Medications for Opioid Use Disorders (MOUD)
Behavioral: Relational Skill Building based on the Nurturing Parenting Program (NPP)
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.
Behavioral: Peer Recovery Support
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Bureau - Administration for Children and Families
Pickaway County Job and Family Services
Fairfield County Job and Family Services
Integrated Services for Behavioral Health (ISBH)
Ohio Guidestone
Fairfield County Juvenile Court
Pickaway County Juvenile Court

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bridget Freisthler, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90CU0083-01-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Datasets will be be stripped of identifying information prior to construction. Specifically, parents (along with one focal child) will be identified with a case and individual identification numbers. No names, addresses, telephone numbers, fax numbers, email addresses, social security numbers, child welfare records, etc. will be retained. We will only share data with external investigators when a data use agreement (DUA) is executed between the Ohio State University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question and the timeline for the project. These data will be made available in Fall, 2023 by the PI.

IPD Sharing Time Frame

Fall 2023

IPD Sharing Access Criteria

With permission via study website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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