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Enhancing Permanency in Children and Families (EPIC)

Primary Purpose

Substance Abuse, Substance Use, Child Abuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Recovery Support
Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)
Relational Skill Building based on the Nurturing Parenting Program (NPP)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance Abuse, Child welfare, Child abuse and neglect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

EPIC Participants

Ohio Sobriety Treatment And Reducing Trauma (START) participants

Treatment as usual (TAU)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time from opening of child welfare case to SUD screening
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.
Time from opening of child welfare case to trauma screening
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.
Change in wait time between referral to addiction treatment services and initiation of services.
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.
Change in addiction severity among participating parents
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.
Change in resilience in children
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.
Change in child behavior
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.
Change length of stay in out-of-home placement for children in EPIC program compared to substance-affected families not receiving EPIC.
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.
Change in reunification among families involved in EPIC compared to substance-affected families not receiving EPIC.
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.
Change in subsequent child welfare involvement among parents receiving EPIC compared to substance-affected families not receiving EPIC
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.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2020
Last Updated
September 19, 2022
Sponsor
Ohio State University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04700696
Brief Title
Enhancing Permanency in Children and Families
Acronym
EPIC
Official Title
Enhancing Permanency in Children and Families
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Substance Use, Child Abuse, Neglect, Child
Keywords
Substance Abuse, Child welfare, Child abuse and neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPIC Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Ohio Sobriety Treatment And Reducing Trauma (START) participants
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Recovery Support
Intervention Description
Weekly visits with peer who has lived experience related to child welfare and addiction
Intervention Type
Behavioral
Intervention Name(s)
Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)
Intervention Description
Incentivized to participate in Family Treatment Drug Court with option for Medications for Opioid Use Disorders (MOUD)
Intervention Type
Behavioral
Intervention Name(s)
Relational Skill Building based on the Nurturing Parenting Program (NPP)
Intervention Description
Home-based parenting support
Primary Outcome Measure Information:
Title
Time from opening of child welfare case to SUD screening
Description
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.
Time Frame
Within 30 days of program entry
Title
Time from opening of child welfare case to trauma screening
Description
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.
Time Frame
Within 30 days of program entry
Title
Change in wait time between referral to addiction treatment services and initiation of services.
Description
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.
Time Frame
Within 30 days of entering child welfare system
Title
Change in addiction severity among participating parents
Description
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.
Time Frame
At program entry and again at program completion. An average of I year
Title
Change in resilience in children
Description
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.
Time Frame
At program entry and again at program completion. An average of I year
Title
Change in child behavior
Description
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.
Time Frame
At program entry and again at program completion. An average of I year
Title
Change length of stay in out-of-home placement for children in EPIC program compared to substance-affected families not receiving EPIC.
Description
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.
Time Frame
Through program completion, an average of 1 year.
Title
Change in reunification among families involved in EPIC compared to substance-affected families not receiving EPIC.
Description
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.
Time Frame
Through program completion, an average of 1 year.
Title
Change in subsequent child welfare involvement among parents receiving EPIC compared to substance-affected families not receiving EPIC
Description
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.
Time Frame
Through completion of 5 year study. For participants, up to 4 years following program participation, depending on time of enrollment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elinam D Dellor, PhD
Phone
614-292-3085
Email
dellor.1@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bridget Freisthler, PhD
Email
freisthler.19@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Freisthler
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elinam Dellor, PhD
Email
dellor.1@osu.edu
First Name & Middle Initial & Last Name & Degree
Bridget Freisthler, PhD
Email
freisthler.19@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://u.osu.edu/epic/
Citations:
PubMed Identifier
33892671
Citation
Freisthler B, Maguire-Jack K, Yoon S, Dellor E, Wolf JP. Enhancing Permanency in Children and Families (EPIC): a child welfare intervention for parental substance abuse. BMC Public Health. 2021 Apr 23;21(1):780. doi: 10.1186/s12889-021-10668-1.
Results Reference
derived
Links:
URL
https://u.osu.edu/epic/
Description
Study website

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Enhancing Permanency in Children and Families

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