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Guardians Receiving Information Through Navigators

Guardians Receiving Information Through Navigators

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07147244
Acronym
GRIN
Enrollment
455
Registered
2025-08-29
Start date
2025-08-01
Completion date
2026-02-28
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Child, Community Health Workers, High-risk, Oral Health

Keywords

Community health workers, Adolescents, Oral Health

Brief 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.

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.

Interventions

OTHERTreatment 1: Full GRIN course (Lessons 1-8)

multi module online training

OTHERTreatment 2: Part 1 of GRIN (Lessons 1-4)

multi module online training

OTHERTreatment 3: Part 2 of GRIN (Lesson 1, 5-8)

multi module online training

Sponsors

KDH Research & Communication
Lead SponsorINDUSTRY
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Knowledge Pretest ScoreBaselineWe 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.
Knowledge Posttest ScorePosttest (1week after baseline)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.
Attitudes Pretest ScorePretest (Baseline)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.
Attitudes Posttest ScorePosttest (2 weeks after baseline)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.
Self-efficacy Pretest ScoreBaselineWe 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.
Self-efficacy Posttest ScorePosttest (2 weeks after baseline)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.
Intentions Pretest ScoreBaselineWe 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.
Intentions Posttest ScorePosttest (2 weeks after baseline)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.
Skills Pretest ScoreBaselineWe 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
Skills Posttest ScorePosttest (2 weeks after baseline)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

Secondary

MeasureTime frameDescription
Satisfaction at Posttest ScorePosttest (2 weeks after baseline)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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDexter L Cooper

KDH Research & Communication

Participant flow

Pre-assignment details

455 participants completed the eligibility and consent form and were eligible to complete the pretest survey. Of the 455 eligible, consented participants, 375 completed the pretest survey and were randomized into the treatment or control groups.

Baseline characteristics

Characteristic
Age, Continuous44.78 Years
STANDARD_DEVIATION 11.11
CHW certification
None
21 Participants
CHW certification
Not sure
9 Participants
CHW certification
State recognized certification
224 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
124 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
Highest education
Bachelor's degree or higher :
46 Participants
Highest education
High School diploma/GED:
0 Participants
Highest education
Other :
59 Participants
Highest education
Prefer not to answer
31 Participants
Highest education
Some college, no degree :
13 Participants
Hours of CHW training in the last 12 months
0-5 hours
39 Participants
Hours of CHW training in the last 12 months
11-20 hours
21 Participants
Hours of CHW training in the last 12 months
21-29 hours
8 Participants
Hours of CHW training in the last 12 months
30+ hours
137 Participants
Hours of CHW training in the last 12 months
6-10 hours
47 Participants
Hours of CHW training in the last 12 months
Not reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
95 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
24 Participants
Sex/Gender, Customized
Sex
Female
134 Participants
Sex/Gender, Customized
Sex
Male
14 Participants
Sex/Gender, Customized
Sex
Unknown
1 Participants
Volunteer or paid position
Both
29 Participants
Volunteer or paid position
Paid
188 Participants
Volunteer or paid position
Volunteer
46 Participants
Years of CHW experience6.36 Years
STANDARD_DEVIATION 6.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026