Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138145
• Other study ID #: 22-019955
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: August 29, 2023

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Participation
• Pediatric ALL

Intervention

Other:
• Video
Different videos were shown for Arms B and C. No Video was shown for Group A or D.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	CHOP Primary Care, Cobbs Creek	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intent	The primary outcome was intended to show who joined the research registry.	Up to 40 weeks

External Links

•   Inclusion Study References