The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs

Trauma, Psychological Clinical Trial

— Impact  

Official title:

The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622138
• Other study ID #: 2R44MH111299
• Status: Completed
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2022
• Source: 3-C Institute for Social Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is an evidence-based program delivered by mental health providers in the school setting. CBITS has been shown to reduce posttraumatic stress disorder (PTSD) symptoms, depression, and anxiety for youth in grades 5-12 as well as improve psychosocial functioning. The 10-session program teaches cognitive behavioral skills using a mixture of didactic presentations, relaxation training, and strategies to combat negative thoughts, reduce avoidance, develop a trauma narrative, and build social problem solving skills. CBITS also includes 1-3 individual child sessions and 2 optional parent sessions.

2. Social Skills Group Intervention K-2 (S.S. GRIN K-2) is an evidence-based program delivered by mental health providers in the school setting to kindergarten through 2nd grade children. S.S. GRIN has been shown to improve self-esteem and self-efficacy, as well as reduce social anxiety and, in aggressive children, reduce aggression and bullying behavior. The intervention includes 10 small group sessions, delivered in an in-person format.

3. The third EBP that will be developed and tested for this Phase II research is Strengthening Families, which has been shown to improve youth outcomes related to substance use, aggressive and hostile behaviors, and risky sexual behaviors, as well as parent protective factors such as affective quality and general child management. The program includes 10-14 sessions, each of which consists of a separate parent and child meeting followed by a family meeting, designed to help families improve communication, conflict resolution, appropriate disciplinary factors, and child involvement in the family. Strengthening Families is implemented in schools, community centers, and mental health facilities by two to four mental health providers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Must be an Evidence-based Prevention Program Provider

• Regularly implement one of the three supported EBPPs to youth in a school or community setting

• Commit to implementing that EBPP over the study period (approximately one school year)

• Serve a minimum of 10 youth over the study period

• Be willing to allow 3C researchers to collect data from their setting

Related Conditions & MeSH terms

• Family Dysfunctional
• Psychological Trauma
• Social Skills
• Trauma, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	3C Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
3-C Institute for Social Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Secondary	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.	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).