Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Participation, Pediatric ALL

Intervention / Treatment
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* Other: Video
* Behavioral: Survey


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

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group A<br>No Video w/ monetary incentive | Other: Video<br>* Different videos were shown for Arms B and C. No Video was shown for Group A or D.<br>Behavioral: Survey<br>* 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.<br>|
| Experimental: Group B<br>Generic video w/ monetary incentive | Other: Video<br>* Different videos were shown for Arms B and C. No Video was shown for Group A or D.<br>Behavioral: Survey<br>* 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.<br>|
| Experimental: Group C<br>Appeal video w/ monetary incentive | Other: Video<br>* Different videos were shown for Arms B and C. No Video was shown for Group A or D.<br>Behavioral: Survey<br>* 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.<br>|
| Sham Comparator: Group D<br>Non-Incentive and no video | Behavioral: Survey<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intent | The primary outcome was intended to show who joined the research registry. | Up to 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inclusion Study, African American Study, African American Pediatrics, Appeal Videos