Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

NCT06138145 | Completed Results

• 1 other identifier: 22-019955
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Participation; Pediatric ALL

Keywords

Inclusion Study; African American Study; African American Pediatrics; Appeal Videos

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Control

EXPERIMENTAL

Text introduction from the Registry, with a gift card.

Other: Video; Behavioral: Survey

Generic

EXPERIMENTAL

Video detailing the Registry's objectives, no tailoring, with a gift card.

Other: Video; Behavioral: Survey

Appeal

EXPERIMENTAL

Generic video edited to include a tailored appeal, with a gift card.

Other: Video; Behavioral: Survey

Ink pen (no) Incentive:

SHAM COMPARATOR

Similar to control but received a University ink pen.

Behavioral: Survey

Interventions

Video OTHER

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

Appeal; Control; Generic

Survey BEHAVIORAL

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.

Appeal; Control; Generic; Ink pen (no) Incentive:

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

CHOP Primary Care, Cobbs Creek

Philadelphia, Pennsylvania, 19139, United States

Location

Related Publications (1)

• Johnson KB, Iannone SL, Furth SL, Taylor L, Tan ASL. Culturally Tailored Messages and Trial Registry Enrollment: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444229. doi: 10.1001/jamanetworkopen.2024.44229.

  PMID: 39531233 DERIVED

Related Links

• Inclusion Study References

MeSH Terms

Conditions

Patient Participation; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Videotape Recording; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Several factors may affect the interpretation of this study. The sample was drawn from a few urban sites, which could limit the representation of marginalized groups. The fourth study arm was recruited six months later, potentially influencing baseline trust and timing. Participants knew about the incentive before consenting, which may have shaped trust perceptions. Only baseline self-reported data were collected, with no follow-up to assess changes in trust or knowledge after the intervention.

Results Point of Contact

• Title: Dr. Kevin B. Johnson
• Organization: University of Pennsylvania

Kevin.Johnson1@Pennmedicine.upenn.edu

215-573-5885

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David L. Cohen University Professor of Pediatrics, Biomedical Informatics, Computer Science and Science Communication

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: November 17, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Locations

US (1)