Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use

March 18, 2026 updated by: Alicia Bunger, Ohio State University
As a result of the opiate crisis, child welfare agencies have experienced an increase in the number of children in foster care as parental substance use puts children at greater risk of maltreatment. To facilitate implementation of the Sobriety Treatment and Recovery Team (START) model, this study (1) identifies collaborative strategies associated with effective implementation and service outcomes given system and organizational context, (2) uses this evidence to specify strategies and develop a decision support guide to help agency leaders select collaborative strategies, and (3) assesses the feasibility, acceptability, and appropriateness of the decision support guide.

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

This is a multi-staged, mixed methods study that leverages a naturally occurring policy experiment in southern Ohio. In aim 1, we will examine the collaborative strategies associated with implementation and service outcomes, given the context with 17 counties engaged in the Ohio START pilot project. We will use a convergent mixed methods design, and integrate our qualitative and quantitative data using qualitative comparative analysis. For aim 2, we will specify the collaborative strategies and develop a decision support guide using the VA's model of implementation strategy development (diagnose barriers, and convene an expert panel to design strategies). For aim 3, we assess the feasibility, acceptability, and appropriateness of the decision support guide using a mixed methods design. In the quantitative phase, we will evaluate the feasibility, acceptability, and appropriateness of each strategy in the toolkit. Our second qualitative phase (which is dominant), will examine feasibility more in-depth by piloting the guide and conducting descriptive case studies with users.

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.
9

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Our participants included implementation support professionals who provide training and technical assistance to child welfare agencies in Ohio that are implementing Ohio START. All individuals will be adults and recruited based on their employment/position.

Exclusion Criteria:

  • Individuals who do not provide implementation support.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group 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: Decision-Support
An electronic copy of a collaboration decision-support guide.
Other: Collaboration Decision Support Guide
Electronic toolkit intended to help organizational leaders select partners and negotiate partnerships for implementation. This will contain: 1) a brief summary of collaboration approaches associated with implementation, 2) detailed descriptions of collaboration strategies, 3) a decision analysis tool that guides the selection of collaborative strategies given the community context, and 4) sample contract or agreement language that specifies the nature of the partnership and expectations.

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
Perceived Acceptability
Time Frame: One time point (Post-test only), 8 weeks after presenting the toolkit
Acceptability of Intervention Measure (AIM) - 4 survey items that assess participants' agreement about the degree to which they perceive the intervention to be acceptable. Participants rate their agreement along a 5 point scale, where 1= completely disagree and 5= completely agree. Scores from the four items will be averaged where higher scores denote greater perceived acceptability. (Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., … Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(108), 1-12. https://doi.org/10.1186/s13012-017-0635-3)
One time point (Post-test only), 8 weeks after presenting the toolkit
Perceived Appropriateness
Time Frame: One time point (Post-test only), 8 weeks after introducing the toolkit
Intervention Appropriateness Measure (IAM) - 4 survey items that assess participants' agreement about the degree to which they perceive the intervention to be appropriate. Participants rate their agreement along a 5 point scale, where 1= completely disagree and 5= completely agree. Scores from the four items will be averaged where higher scores denote greater perceived appropriateness. (Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., … Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(108), 1-12. https://doi.org/10.1186/s13012-017-0635-3)
One time point (Post-test only), 8 weeks after introducing the toolkit
Perceived Feasibility
Time Frame: One time point (Post-test only), 8 weeks after introducing the toolkit
Feasibility of Intervention Measure (FIM) - 4 survey items that assess participants' agreement about the degree to which they perceive the intervention to be feasible. Participants rate their agreement along a 5 point scale, where 1= completely disagree and 5= completely agree. Scores from the four items will be averaged where higher scores denote greater perceived feasibility. (Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., … Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(108), 1-12. https://doi.org/10.1186/s13012-017-0635-3)
One time point (Post-test only), 8 weeks after introducing the toolkit

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.
National Institute on Drug Abuse (NIDA)

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: Alicia Bunger, PhD, 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

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.
April 25, 2024

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.
May 16, 2024

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.
May 31, 2024

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).
April 22, 2019

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.
April 24, 2019

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.
April 29, 2019

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.
April 7, 2026

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.
March 18, 2026

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.
March 1, 2026

More Information

Terms related to this study

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.
  • 2017B0239
  • R34DA046913 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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