NCT04700696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 23, 2024

Status Verified

September 1, 2022

Enrollment Period

5.8 years

First QC Date

November 10, 2020

Last Update Submit

January 19, 2024

Conditions

Keywords

Substance AbuseChild welfareChild abuse and neglect

Outcome Measures

Primary Outcomes (9)

  • 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.

    Within 30 days of program entry

  • 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.

    Within 30 days of program entry

  • 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.

    Within 30 days of entering child welfare system

  • 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.

    At program entry and again at program completion. An average of I year

  • 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.

    At program entry and again at program completion. An average of I year

  • 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.

    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.

    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.

    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

    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

Study Arms (3)

EPIC Participants

EXPERIMENTAL

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 SupportBehavioral: Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)Behavioral: Relational Skill Building based on the Nurturing Parenting Program (NPP)

Ohio Sobriety Treatment And Reducing Trauma (START) participants

ACTIVE COMPARATOR

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

Treatment as usual (TAU)

NO INTERVENTION

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.

Interventions

Weekly visits with peer who has lived experience related to child welfare and addiction

EPIC ParticipantsOhio Sobriety Treatment And Reducing Trauma (START) participants

Incentivized to participate in Family Treatment Drug Court with option for Medications for Opioid Use Disorders (MOUD)

EPIC Participants

Home-based parenting support

EPIC Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Possible substance use, though not primary reason for child welfare involvement
  • incarcerated parents (may enroll after release)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Shockley McCarthy K, Price Wolf J, Dellor E. Promoting permanency in families with parental substance misuse: lessons from a process evaluation of a multi-system program. BMC Public Health. 2022 Dec 3;22(1):2261. doi: 10.1186/s12889-022-14528-4.

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Bridget Freisthler

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2020

First Posted

January 8, 2021

Study Start

October 1, 2017

Primary Completion

July 1, 2023

Study Completion

September 30, 2023

Last Updated

January 23, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Fall 2023
Access Criteria
With permission via study website
More information

Locations