NCT03622138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

July 10, 2018

Last Update Submit

July 11, 2022

Conditions

Keywords

Evidence-based Prevention ProgramsYouth Prevention ProgramsOutcomes DataContinuous Quality Improvement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Attitudes toward EBP Tracking

    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

    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

    This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).

  • Practicality of Impact

    This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).

  • Integration of Impact

    This evaluation measure will be assessed following completion of providers' use of Impact, up to 9 months (POST).

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Other: Impact

Interventions

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.

Experienced EBP ProvidersNaive EBP Providers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Psychological TraumaSocial Skills

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Melissa E DeRosier, PhD

    3C Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 9, 2018

Study Start

June 8, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations