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

Primary Purpose

Substance Use, Implementation, Child Maltreatment

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaboration Decision Support Guide
General Collaboration Support
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision-Support

General Support

Arm Description

An electronic copy of a collaboration decision-support guide.

An electronic copy of general collaboration supports (a list of collaborative implementation strategies and their definitions)

Outcomes

Primary Outcome Measures

Perceived Acceptability
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)
Perceived Appropriateness
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)
Perceived Feasibility
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)

Secondary Outcome Measures

Full Information

First Posted
April 22, 2019
Last Updated
March 30, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03931005
Brief Title
Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use
Official Title
Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Implementation, Child Maltreatment, System Fragmentation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision-Support
Arm Type
Experimental
Arm Description
An electronic copy of a collaboration decision-support guide.
Arm Title
General Support
Arm Type
Active Comparator
Arm Description
An electronic copy of general collaboration supports (a list of collaborative implementation strategies and their definitions)
Intervention Type
Other
Intervention Name(s)
Collaboration Decision Support Guide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General Collaboration Support
Intervention Description
Electronic description of collaborative implementation strategies and their definitions.
Primary Outcome Measure Information:
Title
Perceived Acceptability
Description
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)
Time Frame
One time point (Post-test only), immediately after receipt of intervention
Title
Perceived Appropriateness
Description
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)
Time Frame
One time point (Post-test only), immediately after receipt of intervention
Title
Perceived Feasibility
Description
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)
Time Frame
One time point (Post-test only), immediately after receipt of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Bunger, PhD
Phone
614-688-8366
Email
bunger.5@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elysabeth Bonar Bouton
Phone
614-292-5082
Email
bonarbouton.1@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Bunger, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Bunger, PhD
Phone
614-688-8366
Email
bunger.5@osu.edu
Ext
Bunger
Email
bunger.5@osu.edu
First Name & Middle Initial & Last Name & Degree
Alicia Bunger, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32677987
Citation
Bunger AC, Chuang E, Girth A, Lancaster KE, Gadel F, Himmeger M, Saldana L, Powell BJ, Aarons GA. Establishing cross-systems collaborations for implementation: protocol for a longitudinal mixed methods study. Implement Sci. 2020 Jul 16;15(1):55. doi: 10.1186/s13012-020-01016-9.
Results Reference
derived

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

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