Trauma, PsychologicalImpactNCT03622138
The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs
A study testing Impact in people with Trauma, Psychological and Social Skills, run by 3-C Institute for Social Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological, Social Skills, Family Dysfunctional
- What is being tested?
- Impact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Trauma, Psychological, Social Skills, Family Dysfunctional
- Being tested
- Impact
- Keywords
- Evidence-based Prevention Programs, Youth Prevention Programs, Outcomes Data, Continuous Quality Improvement
- Medical subject headings
- Psychological Trauma, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpactOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Naive EBP Providers | Experimental | 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. Receives: Other: Impact |
| Experienced EBP Providers | Experimental | 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. Receives: Other: Impact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start8 Jun 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa E DeRosier, PhD, Principal investigator, 3C Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622138
- Sponsor's protocol ID
- 2R44MH111299
- Acronym
- Impact
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2018
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs
- ClinicalTrials.gov ID
- NCT03622138
- Acronym / sponsor ID
- Impact / 2R44MH111299
- Conditions
- Trauma, Psychological, Social Skills, Family Dysfunctional
- Keywords
- Evidence-based Prevention Programs, Youth Prevention Programs, Outcomes Data, Continuous Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Aug 2018 (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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naive EBP Providers | Experimental | Other: ImpactNaive 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. |
| Experienced EBP Providers | Experimental | Other: ImpactExperienced 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ImpactImpact 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. | Other | Experienced EBP Providers, Naive EBP Providers |
Primary outcome
Fidelity to the Program Model
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).
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.
9 secondary outcomes
Attitudes toward EBP Tracking
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
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
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Practicality of Impact
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Integration of Impact
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Usability of Impact
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Value of Impact
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Commitment to Change
Time frame: This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).
Time Spent Using Impact
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Melissa E DeRosier, PhD principal investigator
3C Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact in people with Trauma, Psychological and Social Skills, run by 3-C Institute for Social Development 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 12 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity to the Program Model (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.