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RecruitingNCT06375551K-ORCAUpdated Jun 18, 2026

K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions

An interventional study of Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) and Optimizing Responses with Collaborative Assessments-Live (ORCA-L) in Child Abuse, Decision Making and Child Welfare, sponsored by Chestnut Health Systems. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Chestnut Health Systems · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.

Read the detailed description

Over 268,000 children entered foster care in the United States during fiscal year 2019 despite the existence of Maltevidence-based programs (EBPs) that can successfully prevent child maltreatment. Evidence-informed decision-making (EIDM) can lead to the adoption of EBPs that are likely to be successfully implemented and result in the intended impacts. Despite the existence of EBPs to prevent child maltreatment, EBPs are underutilized in child welfare. Proposed study activities in this career development award respond to NIMH Objective 4.2.c by developing, refining, and piloting an implementation strategy to increase EIDM when decision makers are adopting EBPs to improve mental health and child welfare services. Activities leverage an unprecedented federal policy opportunity to prevent child maltreatment and test implementation decision support strategies in the real world: The Family First Prevention Services Act (FFPSA). FFPSA aims to prevent child maltreatment and foster care entries by providing federal funding to states for implementing EBPs that support child and parent mental health, reduce parental substance misuse, and improve parenting skills. This project engages decision makers from four states implementing FFPSA to extend the candidate's prior work developing an innovative EIDM tool to support EBP adoption: Optimizing Responses through Collaborative Assessments (ORCA). ORCA is based in multi-criteria decision analysis, which provides a structured approach to reach quality, evidence-informed group decisions. Given that group decisions with tools such as ORCA benefit from facilitation, this study will develop and test two facilitation modalities to accompany ORCA: automated (ORCA-A) and live (ORCA-L). In addition, a web-based platform to host the ORCA tool and the ORCA-A facilitation strategy will be developed with decision makers' input (Aim 1). The impact of ORCA-A and ORCA-L on quality of decision experiences, processes, and outcomes then will be tested (Aim 2). Implementation process quality for each EBP adopted with ORCA-A and ORCA-L will be monitored (Aim 3). To enhance her strong foundation in the implementation, decision, and systems sciences, the candidate, Dr. Gracelyn Cruden, will leverage these research activities and training activities to expand her skillset to include: leading implementation studies in service systems, employing a continuum of methods for engaging community members, leveraging interdisciplinary approaches for eliciting members' preferences, conducting advanced simulation model testing, and using advanced statistics for multilevel, longitudinal studies. Cruden will be mentored by an outstanding team led by Primary Mentor Dr. Lisa Saldana, who is accompanied by Mentors Dr. Jason Chapman, Dr. Lindsey Zimmerman, Dr. R. Christopher Sheldrick, Dr. Jonathan Purtle, and Consultants Dr. David Vanness, and Ms. Clare Anderson. Upon completion of these activities, Cruden will be equipped to lead an interdisciplinary research team that will support quality mental health and child welfare services by increasing decision makers' use of EIDM.

02

Conditions studied

  • Child Abuse
  • Decision Making
  • Child Welfare
  • Decision Making, Shared
  • Decision Support Technique
  • Social Facilitation
  • Implementation Science
  • Policy
  • Organizations
  • Consensus
  • Mental Health
  • Family
03

In context

Psychological Well-Being

971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

This study's planned enrollment of 80 is below the median of 116 across 830 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

Chestnut Health Systems is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Non-institutionalized
  • Adults (18 years or older).
  • English-Speaking

Aim 1:

  • Involved in initial state decision-making related to Family First Prevention Services Act.
  • Willing to participate in two data collection occasions.

Aim 2:

  • Non-institutionalized
  • Adults (18 years or older). English-Speaking.
  • Involved in ongoing state decision-making related to Family First Prevention Services Act.
  • Willing to participate in three measurement occasions.

Aim 3:

-Willing to participate in multiple (bi-weekly up to two years) measurement occasions.

Exclusion criteria

Exclusion Criteria:

-Not involved in or potentially influencing child welfare intervention decisions

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    ORCA-A

    Decision Makers receiving automated facilitation to accompany ORCA

    Behavioral: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A)

  • Active comparator
    ORCA-L

    Decision Makers receiving live facilitation to accompany ORCA

    Behavioral: Optimizing Responses with Collaborative Assessments-Live (ORCA-L)

Interventions

  • BehavioralOptimizing Responses with Collaborative Assessments-Automated (ORCA-A)

    Participants will receive automated facilitation in the ORCA platform. This will entail prompts for group discussion based on group model building scripts and decision hygiene approaches proposed by Kahneman, Sibony, and Sunstein (2021). Participants will have the option of using these prompts to discuss ORCA results in group decision discussions. Optimizing Responses with Collaborative Assessments (ORCA) is a technical decision support tool based in multi-criteria decision analysis. Decision makers rate and compare evidence-based programs or other practices with ORCA, then prioritize practices for local implementation based on ORCA results. ORCA will be on a virtual platform to allow for web-based completion, automated analysis, and automated facilitation.

  • BehavioralOptimizing Responses with Collaborative Assessments-Live (ORCA-L)

    A facilitator will guide group decision discussions using group model building scripts and decision hygiene approaches proposed by Kahneman, Sibony, and Sunstein (2021). Facilitation will be either in-person or virtual, but occur "live" as in during real-time. Optimizing Responses with Collaborative Assessments (ORCA) is a technical decision support tool based in multi-criteria decision analysis. Decision makers rate and compare evidence-based programs or other practices with ORCA, then prioritize practices for local implementation based on ORCA results. ORCA will be on a virtual platform to allow for web-based completion, automated analysis, and automated facilitation.

06

What researchers measure

Primary outcomes

  1. Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention

    A two-item, quantitative measure will inquire about assumptions and goals in the decision to adopt an intervention. This uses a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly Agree). This outcome is part of Aim 2b: Decision quality based on intervention fit to local context.

    Time frame: Baseline; Immediately Post-intervention

  2. Mean changes in decision experience quality pre-post intervention

    This will be measured across five validated, quantitative sub-scales from a measure of community partnered research: Partner Values, Synergy, Conflict and Cooperation, Participation, Participatory decision-making. Each scale has a range of 1 (Strongly Disagree) to 5 (Strongly Agree).

    Time frame: Baseline; Immediately Post-intervention

  3. Mean changes in decision commitment pre-post intervention

    A two-item, Likert-scale measure regarding the decision maker's confidence in and commitment to implementing the selected intervention(s) will be gathered using a two-item measure. This uses a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly Agree). These scales relate to Aim 2a: decision experience quality.

    Time frame: Baseline; Immediately Post-intervention

  4. Mean changes in perceived potential community health impact pre-post intervention

    This will be measured across a validated, quantitative sub-scale from a measure for community partnered research: Community Health Improvement. This scale has a range of 1 (Strongly Disagree) to 5 (Strongly Agree). This is part of Aim 2b: Decision quality.

    Time frame: Baseline; Immediately Post-intervention; 12-month follow-up

  5. Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA)

    Decision makers will rank interventions in an ordinal manner at baseline using a study-specific survey. Rankings will be calculated post-intervention by ORCA as a function of completing the ORCA tool. The number of ordinal rankings will depend on the number of interventions considered, to be determined by participants. A rank of 1 = highest, followed by 2 ...n. This is part of Aim 2c: Decision quality.

    Time frame: Baseline; Immediately Post-intervention

  6. Qualitatively described rationale for program adoption from pre-post intervention

    This is a study-specific, short, open-ended survey to understand decision makers' rationale for adopting programs during initial Family First Prevention Services Act decisions. There is no scale for the items, given the qualitative, open-ended nature. These are one survey of similar, but related constructs of intervention feasibility, acceptability, and appropriateness. This is part of Aim 2c: Decision quality.

    Time frame: Baseline; Immediately Post-intervention

  7. Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention

    The validated, quantitative Feasibility of Intervention Measure (FIM) will be used to assess perceived implementation feasibility for each intervention considered with ORCA. Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree). This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.

    Time frame: Baseline; Immediately Post-intervention; 12-month post-intervention

  8. Descriptive, mean group-level changes in perceived acceptability of intervention for implementation

    The validated, quantitative Acceptability of Intervention Measure (AIM) will be used to assess perceived implementation feasibility for each intervention considered with ORCA. Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree). This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.

    Time frame: Baseline; Immediately Post-intervention; 12-month post-intervention

  9. Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation

    The validated, quantitative Intervention Appropriateness Measure (IAM) will be used to assess perceived acceptability for each intervention considered with ORCA. Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree). This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.

    Time frame: Baseline; Immediately Post-intervention; 12-month post-intervention

  10. Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA

    A validated measure of implementation activities across 8 stages and 3 phases will be used (Universal Stages of Implementation Completion). Dates are recorded for each activity to be reported or as missing the date, but still being completed. One of the results for the calculated scores is the proportion of activities completed. A higher proportion of activities is generally positive.

    Time frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention

  11. Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA

    A validated measure of implementation activities across 8 stages and 3 phases will be used (Universal Stages of Implementation Completion). Dates are recorded for each activity to be reported or as missing the date, but still being completed. One of the results for the calculated scores is the duration (time elapsed). The ideal duration depends on the proportion score.

    Time frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention

Secondary outcomes

  1. Qualitative changes in decision reasoning pre- post-intervention

    Group discussion transcripts will be analyzed using directed content analysis to identify themes. At baseline and post-intervention, a single-item, study-specific questionnaire will ask participants to express their rationale for adopting the selected intervention(s).

    Time frame: Baseline; Immediately Post-intervention

  2. Qualitative changes in decision goals pre- post-intervention

    Group discussion transcripts will be analyzed using directed content analysis to identify themes. At baseline and post-intervention, a single-item, study-specific questionnaire (the same as in Outcome 12) will ask participants to express their rationale for adopting the selected intervention(s).

    Time frame: Baseline; Immediately Post-intervention

  3. Qualitative changes in decision consensus pre- post-intervention

    Group discussion transcripts will be analyzed using directed content analysis to identify themes. At baseline and post-intervention, a single-item, study-specific questionnaire (the same as in Outcome 12) will ask participants to express their rationale for adopting the selected intervention(s).

    Time frame: Baseline; Immediately Post-intervention

  4. Time to adoption or re-adoption of interventions with ORCA

    Days elapsed from completing ORCA initial time to official decision regarding adopting or re-adopting an intervention. This outcome relates to Aim 2a: decision process quality.

    Time frame: Baseline to adoption of an intervention for implementation, assessed for up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Chestnut Health Systems
    Eugene, Oregon 97401, United States
    Recruiting
08

References and documents

Publications

  • Alley ZM, Chapman JE, Schaper H, Saldana L. The relative value of Pre-Implementation stages for successful implementation of evidence-informed programs. Implement Sci. 2023 Jul 21;18(1):30. doi: 10.1186/s13012-023-01285-0. PubMed 37480144 ↗
  • Oetzel JG, Wallerstein N, Duran B, Sanchez-Youngman S, Nguyen T, Woo K, Wang J, Schulz A, Keawe'aimoku Kaholokula J, Israel B, Alegria M. Impact of Participatory Health Research: A Test of the Community-Based Participatory Research Conceptual Model. Biomed Res Int. 2018 Apr 24;2018:7281405. doi: 10.1155/2018/7281405. eCollection 2018. PubMed 29854784 ↗
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PubMed 28851459 ↗
  • Cruden G, Frerichs L, Powell BJ, Lanier P, Brown CH, Lich KH. Developing a Multi-Criteria Decision Analysis Tool to Support the Adoption of Evidence-Based Child Maltreatment Prevention Programs. Prev Sci. 2020 Nov;21(8):1059-1064. doi: 10.1007/s11121-020-01174-8. Epub 2020 Oct 11. PubMed 33040271 ↗

Study documents

  • Informed consent form · May 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06375551
Lead sponsor
Chestnut Health Systems
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Gracelyn Cruden (Research Scientist, Chestnut Health Systems) — Principal investigator
First posted
Apr 19, 2024
Start date
Dec 1, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

Gracelyn Cruden, PhD
Contact
gcruden@chestnut.org
843-513-9928
Kelli Wright
Contact
kwright@chestnut.org
Gracelyn Cruden, PhD
principal investigator · Chestnut Health Systems

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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