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AzTrials

Oral HealthGRINNCT07147244

Guardians Receiving Information Through Navigators

A study testing Treatment 1: Full GRIN course (Lessons 1-8), Treatment 2: Part 1 of GRIN (Lessons 1-4) and Treatment 3: Part 2 of GRIN (Lesson 1, 5-8) in people with Oral Health and Child, run by KDH Research & Communication at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Oral Health, Child, Adolescent
What is being tested?
Treatment 1: Full GRIN course (Lessons 1-8), Treatment 2: Part 1 of GRIN (Lessons 1-4) and Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
455 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to 28 Feb 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be at least 18 years old.
  • Must have six months of field experience. Investigators define "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
  • Must be an active CHW/health educator/individual who conducts health outreach. Investigators define "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
  • Must have Internet access either at home or at work (or at in-person session).

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

United States1 site
  • KDH Research & Communication

    Atlanta, Georgia, 30309

Other trials in United States

About this study

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

Read the detailed description

The investigators will use a randomized, multi-group, pretest/posttest/follow-up design to test the efficacy of the Guardians Receiving Information Through Navigators (GRIN) course and explore the following research question: To what extent does exposure to the GRIN course relate to positive changes in community health workers' (CHWs') knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians?

GRIN course will have eight full course lessons with text, video vignettes, and artificial intelligence (AI) avatar simulations. The study will consist of pretest, posttest, and 3-month follow-up surveys. CHWs assigned to the treatment group will be exposed to different doses of the intervention, including the full GRIN course (Lessons 1-8), Part 1 of GRIN (Lessons 1-4), or Part 2 of GRIN (Lesson1, 5-8). CHWs assigned to the control group will receive pages from the American Dental Association (ADA) website.

Researchers worked with subject matter experts, dental providers, and the intended audience to ensure the GRIN course reflects the specific needs of CHWs providing outreach to guardians of high-risk adolescents; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to improve their outreach skills.

The Principal Investigator (PI), with input from the subject matter experts and dental providers, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDH Research \& Communication (KDHRC) Institutional Review Board before the evaluation launch.

Investigators will recruit participants through a multi-pronged recruitment strategy including 1) hiring a contractor to manage recruitment of CHWs by sharing study information and consent process to community-based organizations (CBOs) and other CHW organizations; 2) sharing the opportunity through the KDHRC CHW panel, which notifies subscribed CHWs about research opportunities; 3) recruiting at CHW conferences such as the National Association of Community Health Workers (NACHW) Annual Conference; and 4) posting on social media. Notifications and flyers will provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.

The study will include up to 320 CHWs nationwide (160 treatment groups, 160 control groups). The recruitment contractor and sites will refer participants and may have access to potential participant information (e.g., name, email address) from their listservs, but will not have knowledge of who actually serves as study participants and will not have access to enrolled participants' data. KDHRC will remind participants that participation in the study is completely voluntary, that the referral sites will not have knowledge of who actually serves as study participants, and that his or her participation is no way tied to his or her position at and/or relationship with the site that shared referral materials with him or her.

Investigators will confirm consent for each participant and after confirming consent, will send participants the link to complete the pretest survey. Once the investigators receive the pretest survey, they will randomize each participant into the treatment group or control group using a 1:1 randomization. Investigators will alternate assigning each participant with completed pretest to the treatment groups or the control groups. Then, investigators will provide each treatment group participant with access to appropriate treatment link. The control group will be directed to ADA webpages. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.

The investigators will download and export the data from Alchemer into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest, and follow-up responses using the non-personal identifiers and conduct analyses to test for the effect of the GRIN course exposure on changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income guardians of high-risk adolescents.

The initial evaluation criterion is: Statistically significant (p<0.05) and positive relationship between exposure to GRIN course and increased knowledge among the intervention group in comparison to the control group.

Being tested
Treatment 1: Full GRIN course (Lessons 1-8), Treatment 2: Part 1 of GRIN (Lessons 1-4), Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
Keywords
Community health workers, Adolescents, Oral Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment 1: Full GRIN course (Lessons 1-8)Other

    multi module online training

  • Treatment 2: Part 1 of GRIN (Lessons 1-4)Other

    multi module online training

  • Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)Other

    multi module online training

Study groups in NCT07147244
Study groupRoleWhat they receive
Treatment 1: Full GRIN course (Lessons 1-8)ExperimentalLessons 1-8 of professional development training course for CHWs on dental health (GRIN)
Receives: Other: Treatment 1: Full GRIN course (Lessons 1-8)
Treatment 2: Part 1 of GRIN (Lessons 1-4)ExperimentalLessons 1-4 of professional development training course for CHWs on dental health (GRIN)
Receives: Other: Treatment 2: Part 1 of GRIN (Lessons 1-4)
Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)ExperimentalLesson 1, 5-8 of professional development training course for CHWs on dental health (GRIN)
Receives: Other: Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
Control 1No interventionNo intervention
Control 2No interventionNo intervention
Control 3No interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge Pretest Score

    We will ask participants multiple choice knowledge questions related to oral health which we will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answered correctly.

    Measured: Baseline

  2. Knowledge Posttest Score

    We will ask participants multiple choice knowledge questions related to oral health which we will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. We will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answered correctly.

    Measured: Posttest (1week after baseline)

  3. Attitudes Pretest Score

    We will ask all participants Likert-type scale questions about attitudes towards conducting oral health outreach. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest score and 10 being the highest. Higher score means better outcome. Then, we will average these composite scores for each group.

    Measured: Pretest (Baseline)

  4. Attitudes Posttest Score

    We will ask all participants Likert-type scale questions about attitudes towards conducting oral health outreach. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest score and 10 being the highest. Higher score means better outcome. Then, we will average these composite scores for each group.

    Measured: Posttest (2 weeks after baseline)

  5. Self-efficacy Pretest Score

    We will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for both groups.

    Measured: Baseline

  6. Self-efficacy Posttest Score

    We will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for both groups.

    Measured: Posttest (2 weeks after baseline)

  7. Intentions Pretest Score

    We will ask all participants Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for each group.

    Measured: Baseline

  8. Intentions Posttest Score

    We will ask all participants Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for each group.

    Measured: Posttest (2 weeks after baseline)

  9. Skills Pretest Score

    We will ask all participants Likert-type scale questions related to their skills to conduct oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceived skills to providing oral health outreach in the future. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for each group

    Measured: Baseline

  10. Skills Posttest Score

    We will ask all participants Likert-type scale questions related to their skills to conduct oral health outreach. Each rating will range from 1 to 10, with higher ratings representing higher perceived skills to providing oral health outreach in the future. We will average ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, we will average these composite scores for each group

    Measured: Posttest (2 weeks after baseline)

Secondary outcomes (1)
  1. Satisfaction at Posttest Score

    We will ask only the intervention group participants Likert-type scale questions related to their satisfaction with the GRIN course. Each rating will range from 1 to 10, with higher scores representing higher satisfaction with the GRIN intervention. We will average ratings from each question to create an average composite rating for each intervention participant, then we will average these scores across the intervention group. Scores ranged from 1 to 10, with higher scores meaning better satisfaction/outcome.

    Measured: Posttest (2 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion10 Feb 2026
  4. Study completion28 Feb 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07147244
Sponsor's protocol ID
2025-02-04
Other IDs
5R44MD016352-03
Acronym
GRIN
Status last verified
Aug 2026
First submitted
12 Aug 2025
Last updated
28 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment 1: Full GRIN course (Lessons 1-8), Treatment 2: Part 1 of GRIN (Lessons 1-4) and Treatment 3: Part 2 of GRIN (Lesson 1, 5-8) in people with Oral Health and Child, run by KDH Research & Communication 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 4 inclusion and 1 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 28 Aug 2026. 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?

Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Knowledge Pretest Score (time frame: Baseline). The study lists 10 primary outcomes in all. 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 28 Aug 2026.

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