- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03931005
Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use
April 2, 2024 updated by: 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
Not yet recruiting
Intervention / Treatment
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 sequential mixed methods design.
In the first quantitative phase, we will conduct a randomized vignette experiment with agency directors in the 71 Ohio counties that are not involved in the Ohio START pilot project to compare the decision support guide with general implementation support.
Our second qualitative phase (which is dominant), will examine feasibility more in-depth by piloting the guide and conducting descriptive case studies with up to three new counties.
Study Type
Interventional
Enrollment (Estimated)
71
Phase
- 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
- Name: Alicia Bunger, PhD
- Phone Number: 614-688-8366
- Email: bunger.5@osu.edu
Study Contact Backup
- Name: Elysabeth Bonar Bouton
- Phone Number: 614-292-5082
- Email: bonarbouton.1@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
Contact:
- Alicia Bunger, PhD
- Phone Number: 614-688-8366
- Email: bunger.5@osu.edu
-
Contact:
- Email: bunger.5@osu.edu
-
Principal Investigator:
- Alicia Bunger, PhD
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Our participants for our quantitative vignette experiment will include directors (or top-level leaders who collaborate with other organizations in the community) of public child welfare agencies in Ohio who were not involved in the Ohio START pilot project (n = 68). All individuals will be adults and recruited based on their employment/position.
Exclusion Criteria:
- Individuals who do not hold top-level administrative positions (and have do not the authority to develop organizational partnerships in the community)
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Decision-Support
An electronic copy of a 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.
|
Active Comparator: General Support
An electronic copy of general collaboration supports (a list of collaborative implementation strategies and their definitions)
|
Electronic description of collaborative implementation strategies and their definitions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Acceptability
Time Frame: One time point (Post-test only), immediately after receipt of intervention
|
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), immediately after receipt of intervention
|
Perceived Appropriateness
Time Frame: One time point (Post-test only), immediately after receipt of intervention
|
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), immediately after receipt of intervention
|
Perceived Feasibility
Time Frame: One time point (Post-test only), immediately after receipt of intervention
|
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), immediately after receipt of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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 (Estimated)
April 25, 2024
Primary Completion (Estimated)
May 30, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
April 22, 2019
First Submitted That Met QC Criteria
April 24, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017B0239
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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