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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03931005
• Other study ID #: 2017B0239
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Alicia Bunger, PhD
• Phone: 614-688-8366
• Email: bunger.5[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Child Maltreatment
• Implementation
• Substance Use
• Substance-Related Disorders
• System Fragmentation

Intervention

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.
• General Collaboration Support
Electronic description of collaborative implementation strategies and their definitions.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One time point (Post-test only), immediately after receipt of intervention
Primary	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)	One time point (Post-test only), immediately after receipt of intervention
Primary	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)	One time point (Post-test only), immediately after receipt of intervention