Trial Outcomes & Findings for Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities (NCT NCT06274359)
NCT ID: NCT06274359
Last Updated: 2026-08-28
Results Overview
Child participant receipt of 1 or more doses of influenza vaccine from the date influenza vaccines were available at study sites (9/16/24) through the last date of the study period (3/31/25).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
398 participants
Primary outcome timeframe
196 Days
Results posted on
2026-08-28
Participant Flow
Dyads - caregivers and children (6 months to 5 years old) from two safety-net clinics in historically Black neighborhoods in Denver, Colorado - were recruited between August 2nd, 2024 and September 15th, 2024 and followed through March 31, 2025, after which time vaccination status was extracted for children.
This study recruited dyads who were jointly assigned to intervention or usual care. In two cases, siblings were recruited for the study with the same caregiver. Thus, there were a total of 198 caregivers for the 200 children recruited.
Participant milestones
| Measure |
Intervention: Children
Children of caregivers assigned to receive a series (n = 5) of co-created text messages featuring community members' digital stories about why they chose to get an influenza vaccine for their child.
|
Usual Care: Children
Children of caregivers assigned to usual care: a single electronic health record portal message indicating the availability of COVID-19 and influenza vaccines.
|
Intervention: Caregivers
Caregivers of children (6 months to 5 years old) from two safety-net clinics in historically Black neighborhoods in Denver, Colorado were recruited between August 2nd, 2024 and September 15th, 2024 and assigned to the intervention: a series (n = 5) of co-created text messages featuring community members' digital stories about why they chose to get an influenza vaccine for their child.
|
Usual Care: Caregivers
Caregivers of children (6 months to 5 years old) from two safety-net clinics in historically Black neighborhoods in Denver, Colorado were recruited between August 2nd, 2024 and September 15th, 2024 and assigned to the intervention assigned to usual care: a single electronic health record portal message indicating the availability of COVID-19 and influenza vaccines.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
98
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
98
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only adults included in the analyses.
Baseline characteristics by cohort
| Measure |
Intervention: Children
n=100 Participants
Children of caregivers assigned to receive a series (n = 5) of co-created text messages featuring community members' digital stories about why they chose to get an influenza vaccine for their child.
|
Usual Care: Children
n=100 Participants
Children of caregivers assigned to usual care: a single electronic health record portal message indicating the availability of COVID-19 and influenza vaccines.
|
Intervention: Caregivers
n=98 Participants
Caregivers of children (6 months to 5 years old) from two safety-net clinics in historically Black neighborhoods in Denver, Colorado were recruited between September 16, 2024 and March 31, 2025 and assigned to the intervention: a series (n = 5) of co-created text messages featuring community members' digital stories about why they chose to get an influenza vaccine for their child
|
Usual Care: Caregivers
n=100 Participants
Caregivers of children (6 months to 5 years old) from two safety-net clinics in historically Black neighborhoods in Denver, Colorado were recruited between September 16, 2024 and March 31, 2025 and assigned to usual care: a single electronic health record portal message indicating the availability of COVID-19 and influenza vaccines.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age in years of participating caregivers
|
—
|
—
|
30.8 Years
STANDARD_DEVIATION 7.6 • n=98 Participants • Only adults included in the analyses.
|
30.2 Years
STANDARD_DEVIATION 7.4 • n=100 Participants • Only adults included in the analyses.
|
30.5 Years
STANDARD_DEVIATION 7.5 • n=198 Participants • Only adults included in the analyses.
|
|
Age, Customized
Age in months of participating children
|
28.1 Months
STANDARD_DEVIATION 15.4 • n=100 Participants • Only children included in analyses.
|
30.0 Months
STANDARD_DEVIATION 16.7 • n=100 Participants • Only children included in analyses.
|
—
|
—
|
29.1 Months
STANDARD_DEVIATION 16.1 • n=200 Participants • Only children included in analyses.
|
|
Sex: Female, Male
Female
|
47 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
57 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
90 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
91 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
285 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Sex: Female, Male
Male
|
53 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
43 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
8 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
9 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
113 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
43 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
44 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
43 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
177 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
52 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
54 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
57 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
212 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
5 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
0 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
0 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
9 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Race/Ethnicity, customized
Black or African American
|
38 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
39 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
34 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
43 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
154 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Race/Ethnicity, customized
Another Race and or Ethnicity
|
58 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
56 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
64 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
57 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
235 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
|
Race/Ethnicity, customized
Missing or Prefer Not to Answer
|
4 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
5 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
0 Participants
n=98 Participants • Any difference between population and specific groups is attributed to chance.
|
0 Participants
n=100 Participants • Any difference between population and specific groups is attributed to chance.
|
9 Participants
n=398 Participants • Any difference between population and specific groups is attributed to chance.
|
PRIMARY outcome
Timeframe: 196 DaysPopulation: There were 100 children of caregivers assigned to the intervention who were participants and 100 children of caregivers assigned to usual care who were participants.
Child participant receipt of 1 or more doses of influenza vaccine from the date influenza vaccines were available at study sites (9/16/24) through the last date of the study period (3/31/25).
Outcome measures
| Measure |
Intervention: Children
n=100 Participants
Children of caregivers assigned to the intervention.
|
Usual Care: Children
n=100 Participants
Children of caregivers assigned to usual care.
|
|---|---|---|
|
Child Participant Vaccination During the 2024-2025 Influenza Season
|
41 Participants with 1 or more vaccinations
|
28 Participants with 1 or more vaccinations
|
SECONDARY outcome
Timeframe: 181 daysPopulation: Only caregivers assigned to the intervention would have been able to watch a digital story.
Percentage of caregivers assigned to intervention who watched one or more digital stories from the date the first story was sent out (10/1/24) through the study period end (3/31/25).
Outcome measures
| Measure |
Intervention: Children
n=98 Participants
Children of caregivers assigned to the intervention.
|
Usual Care: Children
Children of caregivers assigned to usual care.
|
|---|---|---|
|
Digital Story Reach
|
7 Participants
|
0 Participants
|
Adverse Events
Intervention: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place