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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03931005

Recruitment Status Not yet recruiting

First Posted April 29, 2019

Last update posted May 4, 2020

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.

  • Condition or Disease:Substance Use
    Implementation
    Child Maltreatment
    System Fragmentation
  • Intervention/Treatment: Other: Collaboration Decision Support Guide
    Other: General Collaboration Support
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2021
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: July 2022
Arms and interventions
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.
Outcome Measures
  • 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)
Eligibility Criteria
  • 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)

Contacts and Locations
Contacts

Contact: Alicia Bunger, PhD 614-688-8366 bunger.5@osu.edu

Contact: Lori Blum 614-688-2392 blum.71@osu.edu

Locations

United States, Ohio
The Ohio State University
Columbus

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Alicia Bunger, PhD Ohio State University

More Information
  • Responsible Party: Ohio State University
  • ClinicalTrials.gov Identifier: NCT03931005 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No