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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Patient Participation
• Intervention / Treatment: Behavioral: Survey; Other: Video

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CHOP Primary Care, Cobbs Creek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Text introduction from the Registry, with a gift card.	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.; Other: Video; Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups
Experimental: Generic; Video detailing the Registry's objectives, no tailoring, with a gift card.	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.; Other: Video; Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups
Experimental: Appeal; Generic video edited to include a tailored appeal, with a gift card.	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.; Other: Video; Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups
Sham Comparator: Ink pen (no) Incentive: Similar to control but received a University ink pen.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 40 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Children's Hospital of Philadelphia

Publications and helpful links

Helpful Links

• Inclusion Study References

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Inclusion Study; African American Study; African American Pediatrics; Appeal Videos
• Other Study ID Numbers: 22-019955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No