Clinical Trials Logo

Clinical Trial Summary

Two arm study, experimental and control, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of African American youth via their caregivers.


Clinical Trial Description

The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the GRIN prototype and explore the following research question: To what extent does exposure to the GRIN prototype relate to positive changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians? The community-driven nature of the project will ground the evaluation in the principles of an equitable evaluation that incorporates a racial equity lens. An equitable evaluation is "an approach that addresses the dynamics and practices that have historically undervalued the voices, knowledge, expertise, capacity, and experiences of all evaluation participants and stakeholders, particularly people of color and other marginalized groups." This approach "requires that evaluators engage in a process of ongoing self-reflection and adjustment, including a willingness to question and adapt traditional evaluation methods in response to stakeholder input." Working with communities to reflect the specific needs of their constituents, investigators will develop and enhance collaborations that leverage stakeholder expertise; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with low-income Black guardians. The PI, with input from the SC, will develop necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials, which then be reviewed against an equitable evaluation checklist, obtaining input on revisions from community members where needed. The PI will also outline the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDHRC Institutional Review Board before the evaluation launch. The investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include National Association of Community Health Workers (NACHW) and the University of Southern Mississippi College of Nursing and Health Professionals (see Letters of Support for more details). The notification will provide information about the goal of the study, participant eligibility, and a link to an interest and eligibility form. Once a potential participant completes the interest and eligibility form and s/he is eligible for the project, they will receive a link to a consent form located on a secure online platform. CHWs will be randomly assigned to the intervention or control group after consent and enrollment in the study. All participants will complete an online pretest survey. The intervention group will be exposed to GRIN and will complete an online posttest survey two weeks after completing the GRIN modules. The control group participants will not be exposed to the GRIN program and will complete a posttest two weeks after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers. The investigators will download and export the data from SurveyGizmo into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of GRIN exposure on changes in CHWs' knowledge, attitudes and beliefs, self-efficacy, and intentions to conduct pediatric oral health care outreach to low-income Black guardians. The a priori feasibility criterion is: Statistically significant differences between pretest and posttest knowledge and self-efficacy measures among the intervention group participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05511935
Study type Interventional
Source KDH Research & Communication
Contact
Status Completed
Phase N/A
Start date January 1, 2022
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT01009554 - Oral Tissue Tolerance of a Mouthrinse N/A
Completed NCT00103493 - Oral Health Education Program Phase 3
Completed NCT04302987 - Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)
Completed NCT00658489 - Implementation and Evaluation of Bright Futures Curriculum Within CORNET Continuity Practice N/A
Completed NCT01726179 - Efficacy of Proximal Caries Infiltration N/A