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Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06138145
Enrollment
125
Registered
2023-11-18
Start date
2022-11-17
Completion date
2023-08-29
Last updated
2025-04-18

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

Conditions

Patient Participation, Pediatric ALL

Keywords

Inclusion Study, African American Study, African American Pediatrics, Appeal Videos

Brief summary

An informational video about joining a Research Notification Registry is being compared with a version of the video tailored to African/ African American parents, reminding them about the importance of their being included in clinical trials. African/African American parents and caregivers of children under 13 years of age are targeted.

Detailed description

Improving diversity in research projects and national data repositories is critical to providing safe and effective care to marginalized groups. Unfortunately, certain groups such as African Americans are inadequately represented in much of the available data and in current clinical trials. Recently, investigators have begun employing new messaging approaches to increase diversity in clinical trial enrollment. These messages are typically designed to inform, with no appeal for specific groups to act, and no tailoring that takes into account specific groups. Very little is known about the potential impact of inclusion appeals--direct appeals to historically marginalized groups calling on their need to be included in research studies. Applying the science of appeals to recruitment messages may improve the effectiveness of educational videos and lead to greater participation in research. This pilot study proposes to empirically study whether an inclusion appeal increases decisions to enroll children in studies.

Interventions

OTHERVideo

Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups

BEHAVIORALSurvey

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Sponsors

Children's Hospital of Philadelphia
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 1. English speaking 2. Self-identified African or African American 3. Not already enrolled in any research participant registry, no history of clinical trial participation 4. At least one child in their care age newborn to 13 Exclusion: 1. Parents with children over the age of 13 2. Non-English speakers 3. Previously enrolled in Children's Hospital of Philadelphia registry, history of clinical trial participation

Design outcomes

Primary

MeasureTime frameDescription
Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials RegistryUp to 40 weeksNumber of Participants with who made the decision to enroll in the CHOP pediatric clinical trials registry.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
No Video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. Survey: Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.
29
Generic
Generic video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. Survey: Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.
30
Appeal
Appeal video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. Survey: Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.
34
Ink Pen (no) Incentive
Non-Incentive and no video Survey: Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.
32
Total125

Baseline characteristics

CharacteristicGenericAppealInk Pen (no) IncentiveControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants34 Participants32 Participants29 Participants125 Participants
Age, Continuous32.8 years32.3 years33.1 years32.3 years32.6 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
28 Participants30 Participants29 Participants28 Participants115 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants0 Participants2 Participants1 Participants4 Participants
Region of Enrollment
United States
30 participants34 participants32 participants29 participants125 participants
Sex: Female, Male
Female
26 Participants30 Participants28 Participants26 Participants110 Participants
Sex: Female, Male
Male
4 Participants4 Participants4 Participants3 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry

Number of Participants with who made the decision to enroll in the CHOP pediatric clinical trials registry.

Time frame: Up to 40 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlParticipants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry29 Participants
GenericParticipants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry30 Participants
AppealParticipants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry34 Participants
Ink Pen (no) IncentiveParticipants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry32 Participants
p-value: <0.001Chi-squared
p-value: <0.05Mann-Whitney U test
p-value: <0.05Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026