An interventional study of Impact in Trauma, Psychological, Social Skills and Family Dysfunctional, sponsored by 3-C Institute for Social Development. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by 3-C Institute for Social Development · Not applicable, Interventional, and Health services research
There has been substantial progress in developing evidence-based prevention programs (EBPPs) for preventing risky behaviors and promoting positive outcomes for youth. Unfortunately, their adoption, quality implementation, long-term sustainability, and scalability in real world service settings, continues to lag far behind resulting in an inability to achieve the intended broad scale public impact. This SBIR Phase II project will build on the findings and feedback gathered from stakeholders in the Phase I project to fully develop and test the Impact implementation support system. Impact will provide an easy to use, cost- and time-efficient technology platform that is capable of (a) gathering relevant process and outcomes data in a feasible way within real-world service settings; (b) producing real-time analytics (e.g., graphical displays) and meaningful reports at the provider, service setting, and broader levels (e.g., state-wide); and (c) linking data analytics to continuous quality improvement (CQI) feedback to help providers achieve best practices and targeted youth outcomes.
Describe the objective(s) of the proposed research including purpose, research question and design, anticipated length of the entire study, hypothesis and relevant background information.
There has been substantial progress in developing evidence-based prevention programs (EBPPs) for preventing risky behaviors and promoting positive outcomes for youth. Unfortunately, their adoption, quality implementation, long-term sustainability, and scalability in real world service settings, continues to lag far behind resulting in an inability to achieve the intended broad scale public impact. This SBIR Phase II project will build on the findings and feedback gathered from stakeholders in the Phase I project to fully develop and test the Impact implementation support system. Impact will provide an easy to use, cost- and time-efficient technology platform that is capable of (a) gathering relevant process and outcomes data in a feasible way within real-world service settings; (b) producing real-time analytics (e.g., graphical displays) and meaningful reports at the provider, service setting, and broader levels (e.g., state-wide); and (c) linking data analytics to continuous quality improvement (CQI) feedback to help providers achieve best practices and targeted youth outcomes.
For this Phase II project, 3C will create three instantiations (or 'instances') of Impact, i.e., one instance for each of three EBPPs. These EBPPs explicitly target one or more mental health outcomes for youth, and provide a test of the application of Impact to a variety of service delivery models, including small group-based, universal classroom, and parent training:
The proposed three-year project will accomplish three specific aims: (1) fully develop the Impact software platform for the three Blueprints-supported EBPPs listed above, (2) conduct a pilot field study to test whether and in what ways Impact is superior to currently used process and outcomes tracking methods for each EBPP, and (3) prepare Impact for commercialization.
Impact's technology infrastructure will be able to accommodate a wide array of EBPPs, providing a much needed cost-effective mechanism to support broad-scale dissemination and use in service settings. In addition, administrators will be able to track implementation, thus enhancing accountability and providing on-going quality assurance, while also providing data analytics to quickly and effectively monitor impact and cost-effectiveness, thereby increasing the likelihood a program's core features are adhered to over time and maximizing treatment benefits for youth.
Inclusion Criteria:
Naive Providers (providers with no prior experience implementing the EBP) will attend a one-hour orientation meeting via web-based meeting software (e.g., WebEx) or in person to receive training on research procedures and implementation methods for the study. Participants will complete online surveys via 3C's secure system for any measures not collected directly via Impact. Providers will receive secure login information to the survey system and automatic email alerts with links to surveys to prompt completion. Surveys will be completed at PRE and POST time points to assess feasibility, usability, and value. 3C research staff will be available to assist providers (via email and phone) throughout the pilot field study.
Other: Impact
Experienced EBP Providers (providers with prior experience implementing the EBP) will attend a one-hour orientation meeting via web-based meeting software (e.g., WebEx) or in person to receive training on research procedures and implementation methods for the study. Participants will complete online surveys via 3C's secure system for any measures not collected directly via Impact. Providers will receive secure login information to the survey system and automatic email alerts with links to surveys to prompt completion. Surveys will be completed at PRE and POST time points to assess feasibility, usability, and value. 3C research staff will be available to assist providers (via email and phone) throughout the pilot field study.
Other: Impact
Impact is an easy to use, cost- and time-efficient technology platform that is capable of (a) gathering relevant process and outcomes data in a feasible way within real-world service settings; (b) producing real-time analytics (e.g., graphical displays) and meaningful reports at the provider, service setting, and broader levels (e.g., state-wide); and (c) linking data analytics to continuous quality improvement (CQI) feedback to help providers achieve best practices and targeted youth outcomes.
Fidelity to the Program Model
Providers will complete a Fidelity form, and will receive a total score ranging from 0 to 100, with 80 or higher representing better outcomes. Scores are calculated by converting responses (1 to 5) to percentage (0 to 100) and averaging item percentages.
Time frame: To assess change, this measure will be taken each time providers enter data into the Impact system after each session (once per week for up to 12 weeks).
Attitudes toward EBP Tracking
Providers will complete the 22-item Attitudes Towards Standardized Assessment scale which measures provider perceptions of using data in practice. Three subscale scores will be calculated by averaging responses of each item within that subscale. Scores range from 1=Strongly Agree to 5=Strongly Disagree with 5 being the better outcome.
Time frame: To assess change, this measure will be taken (1) at baseline (PRE) and (2) following completion of providers' use of Impact, up to 9 months (POST).
Skilled Use of Data
Providers will rate their understanding of and skill using data for an EBP using an 8-item Skilled Use of Data scale, measuring self-reported skill level for using data related to an EBP. Scores range from 1=Minimal to 5=Advanced, with 5 being the better outcome. A total score is calculated by averaging responses for each item.
Time frame: To assess change, this measure will be taken (1) at baseline (PRE) and (2) following completion of providers' use of Impact, up to 9 months (POST).
Satisfaction with Impact assessed by Acceptability Scale
Providers will rate their satisfaction with using Impact as a method to enter and track data using an 80-item Acceptability scale across 10 domains. A subscale score will be calculated for each domain by averaging scores for each item within that domain. Scores range from 1=Definitely No to 5=Definitely Yes, with 5 being the better outcome.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Practicality of Impact
Providers will complete a Practicality evaluation scale (80 items across 10 domains). A score will be calculated for each domain, for a total of 10 subscale scores. Each subscale score ranges from 1=Very Low to 7=Very High, with 7 being the better outcome. Subscale scores are calculated by averaging the item responses within each subscale.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Integration of Impact
Providers will complete an 8-item evaluation scale (Integration of Impact) measuring how well Impact works with other systems. A total score for this scale will be calculated by averaging item responses, and scores range from 1=Strongly Disagree to 7=Strongly Agree, where 7 is the better outcome.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Usability of Impact
Providers will complete a 20-item Usability scale adapted from the Post-Study System Usability Questionnaire (PSSUQ). Three subscale scores will be calculated, and each ranges from 7=Strongly Disagree to 1=Strongly Agree, with 1 being the better outcome. Scores are calculated by averaging item responses within each subscale.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Value of Impact
Providers will complete the 8-item Value of Impact scale, and a total score will be calculated by averaging item responses. Scores range from 1=Poor to 5=Excellent, with 5 being the better outcome.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Commitment to Change
Providers will complete the 18-item Commitment to Change scale, which measures how committed providers are to use Impact in their organization. Three subscale scores are calculated, and each score ranges from 1=Strongly Disagree to 7=Strongly Agree, with 7 being the better outcome. Scores are calculated by averaging item responses within each subscale.
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Time Spent Using Impact
Providers will report the amount of time it takes them to complete all activities (e.g., data entry, generating reports) using Impact. Time will be reported in minutes.
Time frame: This measure will be assessed each week while providers are implementing the EBP and using the Impact system (once per week, up to 12 weeks).
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
3-C Institute for Social Development