Clinical trial NCT03622138: The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs
Official title: The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma, Psychological
Social Skills
Family Dysfunctional
Keywords: Evidence-based Prevention Programs
Youth Prevention Programs
Outcomes Data
Continuous Quality Improvement
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 203
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fidelity to the Program Model
timeFrame: 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 outcomes:
measure: Attitudes toward EBP Tracking
timeFrame: 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).
measure: Skilled Use of Data
timeFrame: 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).
measure: Satisfaction with Impact assessed by Acceptability Scale
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Practicality of Impact
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Integration of Impact
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Usability of Impact
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Value of Impact
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Commitment to Change
timeFrame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
measure: Time Spent Using Impact
timeFrame: 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).
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3C Institute
name: Melissa E DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
References: