Trial Outcomes & Findings for An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination (NCT NCT03628885)
NCT ID: NCT03628885
Last Updated: 2019-04-02
Results Overview
Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
908 participants
Primary outcome timeframe
Immediately after video intervention has been administered
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
General Vaccine Information
Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
|
Top Concern Tailored Intervention
Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).
Top Concern Tailored Intervention: General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
|
All Concerns Tailored Intervention
Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".
All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.
|
|---|---|---|---|
|
Overall Study
STARTED
|
306
|
299
|
303
|
|
Overall Study
COMPLETED
|
267
|
252
|
243
|
|
Overall Study
NOT COMPLETED
|
39
|
47
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination
Baseline characteristics by cohort
| Measure |
General Vaccine Information
n=306 Participants
Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
|
Top Concern Tailored Intervention
n=299 Participants
Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).
Top Concern Tailored Intervention: General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
|
All Concerns Tailored Intervention
n=303 Participants
Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".
All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.
|
Total
n=908 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
21-25 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Customized
25-30 years old
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Customized
31-35 years old
|
72 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Age, Customized
36-40 years old
|
84 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
|
Age, Customized
41-45 years old
|
63 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Age, Customized
46-50 years old
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Age, Customized
51-55 years old
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Customized
56-60 years old
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Customized
61-65 years old
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
66-70 years old
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
70-75 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female · Female
|
306 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
908 Participants
n=4 Participants
|
|
Sex: Female, Male
Female · Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
217 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
675 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
31 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Child's Sex: Female, Male
Females
|
153 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Child's Sex: Female, Male
Males
|
153 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
448 Participants
n=4 Participants
|
|
Child's Age, Continuous
|
12.28 Years
STANDARD_DEVIATION 1.12 • n=5 Participants
|
12.33 Years
STANDARD_DEVIATION 1.15 • n=7 Participants
|
12.60 Years
STANDARD_DEVIATION 1.15 • n=5 Participants
|
12.40 Years
STANDARD_DEVIATION 1.15 • n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately after video intervention has been administeredEach parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.
Outcome measures
| Measure |
General Vaccine Information
n=267 Participants
Brief (47 second) animated informational video about vaccines recommended for all young adolescents.
|
Top Concern Tailored Intervention
n=252 Participants
Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).
Top Concern Tailored Intervention: General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
|
All Concerns Tailored Intervention
n=243 Participants
Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".
All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.
|
|---|---|---|---|
|
Intention to Vaccinate Against HPV in the Next 12 Months
|
3.49 score on a scale
Interval 3.2 to 3.8
|
3.87 score on a scale
Interval 3.6 to 4.2
|
4.16 score on a scale
Interval 3.8 to 4.6
|
Adverse Events
General Vaccine Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Top Concern Tailored Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Concerns Tailored Intervention
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