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

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ClinicalTrials.gov Identifier: NCT03931005
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Substance Use Implementation Child Maltreatment System Fragmentation Other: Collaboration Decision Support Guide Other: General Collaboration Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use
Estimated Study Start Date : May 31, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Active Comparator: General Support
An electronic copy of general collaboration supports (a list of collaborative implementation strategies and their definitions)
Other: General Collaboration Support
Electronic description of collaborative implementation strategies and their definitions.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931005


Contacts
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Contact: Alicia Bunger, PhD 614-688-8366 bunger.5@osu.edu
Contact: Lori Blum 614-688-2392 blum.71@osu.edu

Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Contact: Alicia Bunger, PhD    614-688-8366    bunger.5@osu.edu   
Contact       bunger.5@osu.edu   
Principal Investigator: Alicia Bunger, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Alicia Bunger, PhD Ohio State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT03931005    
Other Study ID Numbers: 2017B0239
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No