Child AbuseK-ORCANCT06375551
K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions
A study testing Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) and Optimizing Responses with Collaborative Assessments-Live (ORCA-L) in people with Child Abuse and Decision Making, run by Chestnut Health Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Abuse, Decision Making, Child Welfare
- What is being tested?
- Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) and Optimizing Responses with Collaborative Assessments-Live (ORCA-L)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- -Not involved in or potentially influencing child welfare intervention decisions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelli Wright contact
United States1 site, 1 recruiting
- Recruiting
Chestnut Health Systems
Eugene, Oregon, 97401
Gracelyn Cruden, PhD, 309-451-7868, gcruden@chestnut.org
Jessica Harrison, MS, jlharrison@chestnut.org
About this study
Official title: Refining and Pilot Testing a Decision Support Intervention to Facilitate Adoption of Evidence-Based Programs to Improve Parent and Child Mental Health
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.
- Conditions
- Child Abuse, Decision Making, Child Welfare, Decision Making, Shared, Decision Support Technique, Social Facilitation
- Being tested
- Optimizing Responses with Collaborative Assessments-Automated (ORCA-A), Optimizing Responses with Collaborative Assessments-Live (ORCA-L)
- Medical subject headings
- Social Facilitation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimizing Responses with Collaborative Assessments-Automated (ORCA-A)Behavioural
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.
Optimizing Responses with Collaborative Assessments-Live (ORCA-L)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ORCA-A | Active comparator | Decision Makers receiving automated facilitation to accompany ORCA Receives: Behavioral: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) |
| ORCA-L | Active comparator | Decision Makers receiving live facilitation to accompany ORCA Receives: Behavioral: Optimizing Responses with Collaborative Assessments-Live (ORCA-L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Immediately Post-intervention
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).
Measured: Baseline; Immediately Post-intervention
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.
Measured: Baseline; Immediately Post-intervention
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.
Measured: Baseline; Immediately Post-intervention; 12-month follow-up
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.
Measured: Baseline; Immediately Post-intervention
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.
Measured: Baseline; Immediately Post-intervention
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.
Measured: Baseline; Immediately Post-intervention; 12-month post-intervention
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.
Measured: Baseline; Immediately Post-intervention; 12-month post-intervention
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.
Measured: Baseline; Immediately Post-intervention; 12-month post-intervention
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.
Measured: Immediately Post-intervention; bi-weekly through 12-month post-intervention
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.
Measured: Immediately Post-intervention; bi-weekly through 12-month post-intervention
Secondary outcomes (4)
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).
Measured: Baseline; Immediately Post-intervention
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).
Measured: Baseline; Immediately Post-intervention
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).
Measured: Baseline; Immediately Post-intervention
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.
Measured: Baseline to adoption of an intervention for implementation, assessed for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Dec 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gracelyn Cruden, Chestnut Health Systems
- Investigators
- Gracelyn Cruden, PhD, Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375551
- Sponsor's protocol ID
- 1171-0623
- Other IDs
- K01MH128761
- Acronym
- K-ORCA
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37480144Oetzel 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 29854784Weiner 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 28851459Cruden 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 at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining and Pilot Testing a Decision Support Intervention to Facilitate Adoption of Evidence-Based Programs to Improve Parent and Child Mental Health
- ClinicalTrials.gov ID
- NCT06375551
- Acronym / sponsor ID
- K-ORCA / 1171-0623
- Conditions
- Child Abuse, Decision Making, Child Welfare, Decision Making, Shared, Decision Support Technique, Social Facilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORCA-A | Active comparator | Behavioral: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A)Decision Makers receiving automated facilitation to accompany ORCA |
| ORCA-L | Active comparator | Behavioral: Optimizing Responses with Collaborative Assessments-Live (ORCA-L)Decision Makers receiving live facilitation to accompany ORCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Non-institutionalized
- Adults (18 years or older).
- English-Speaking
- Involved in initial state decision-making related to Family First Prevention Services Act.
- Willing to participate in two data collection occasions.
Key exclusion criteria (1 listed)
- -Not involved in or potentially influencing child welfare intervention decisions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimizing 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. | Behavioural | ORCA-A |
| Optimizing 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. | Behavioural | ORCA-L |
Primary outcome
Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention
Time frame: Baseline; 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.
Mean changes in decision experience quality pre-post intervention
Time frame: Baseline; Immediately 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).
Mean changes in decision commitment pre-post intervention
Time frame: Baseline; Immediately 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.
Mean changes in perceived potential community health impact pre-post intervention
Time frame: Baseline; Immediately Post-intervention; 12-month follow-up
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.
Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA)
Time frame: Baseline; Immediately Post-intervention
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.
Qualitatively described rationale for program adoption from pre-post intervention
Time frame: Baseline; Immediately 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.
Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention
Time frame: Baseline; Immediately Post-intervention; 12-month 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.
Descriptive, mean group-level changes in perceived acceptability of intervention for implementation
Time frame: Baseline; Immediately Post-intervention; 12-month post-intervention
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.
Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation
Time frame: Baseline; Immediately Post-intervention; 12-month post-intervention
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.
Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA
Time frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
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.
Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA
Time frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
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.
4 secondary outcomes
Qualitative changes in decision reasoning pre- post-intervention
Time frame: Baseline; Immediately Post-intervention
Qualitative changes in decision goals pre- post-intervention
Time frame: Baseline; Immediately Post-intervention
Qualitative changes in decision consensus pre- post-intervention
Time frame: Baseline; Immediately Post-intervention
Time to adoption or re-adoption of interventions with ORCA
Time frame: Baseline to adoption of an intervention for implementation, assessed for up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 37480144Alley 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.
- Background: PubMed 29854784Oetzel 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.
- Background: PubMed 28851459Weiner 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.
- Background: PubMed 33040271Cruden 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.
- Individual participant dataSharing planned: No
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Female, Abuse Neglect
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelli Wright contact
Gracelyn Cruden, PhD principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) and Optimizing Responses with Collaborative Assessments-Live (ORCA-L) in people with Child Abuse and Decision Making, run by Chestnut Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gracelyn Cruden, PhD (843-513-9928, gcruden@chestnut.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention (time frame: Baseline; Immediately Post-intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375551, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.