AzTrials
AzTrials

Substance AbuseEPICNCT04700696

Enhancing Permanency in Children and Families

A study testing Peer Recovery Support, Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD) and Relational Skill Building based on the Nurturing Parenting Program (NPP) in people with Substance Abuse and Substance Use, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Substance Abuse, Substance Use, Child Abuse
What is being tested?
Peer Recovery Support, Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD) and Relational Skill Building based on the Nurturing Parenting Program (NPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the 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.

Being tested
Peer Recovery Support, Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD), Relational Skill Building based on the Nurturing Parenting Program (NPP)
Keywords
Substance Abuse, Child welfare, Child abuse and neglect
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer Recovery SupportBehavioural

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

  • Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)Behavioural

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

  • Relational Skill Building based on the Nurturing Parenting Program (NPP)Behavioural

    Home-based parenting support

Study groups in NCT04700696
Study groupRoleWhat they receive
EPIC ParticipantsExperimentalEPIC 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.
Receives: Behavioral: Peer Recovery Support; Behavioral: 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) participantsActive comparatorAdapted 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.
Receives: Behavioral: Peer Recovery Support
Treatment as usual (TAU)No interventionTreatment 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 30 days of program entry

  2. 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.

    Measured: Within 30 days of program entry

  3. 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.

    Measured: Within 30 days of entering child welfare system

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: Through program completion, an average of 1 year.

  8. 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.

    Measured: Through program completion, an average of 1 year.

  9. 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.

    Measured: Through completion of 5 year study. For participants, up to 4 years following program participation, depending on time of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021
  2. Study start1 Oct 2017
  3. Primary completion1 Jul 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700696
Sponsor's protocol ID
90CU0083-01-00
Acronym
EPIC
Status last verified
Sep 2022
First submitted
10 Nov 2020
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36463173
  • 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.

    PubMed 33892671

Questions about this trial

What is this clinical trial studying?

A study testing Peer Recovery Support, Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD) and Relational Skill Building based on the Nurturing Parenting Program (NPP) in people with Substance Abuse and Substance Use, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from opening of child welfare case to SUD screening (time frame: Within 30 days of program entry). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700696, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in