NCT05746585

Brief Summary

The purpose of this study is to construct the first nurse-led web-based intervention, The TALK, a parent-centered, adolescent-involved health promotion intervention for Black male adolescents and young adults (AYA). Through the use of entertainment videos and educational modules, investigators will provide parents with resources and tools for communicating with their adolescents about sexual health and experiences of racial discrimination, and how these experiences impact sexual health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

January 23, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Usability

    Usability of The TALK as measured by number of website uses

    6 months

  • Acceptability

    Acceptability of The TALK as measured by participant survey feedback

    6 months

  • Communication Frequency

    Frequency of parent-adolescent sexual health communication measured by survey feedback

    6 months

  • Communication Quality

    Quality of parent-adolescent sexual health communication as measured by survey feedback

    6 months

Study Arms (1)

The TALK intervention for Black male adolescents and young adults (AYA)

EXPERIMENTAL

The TALK, a parent-centered, adolescent-involved health promotion intervention for Black male adolescents and young adults (AYA). Through the use of entertainment videos and educational modules, investigators will provide parents with resources and tools for communicating with their adolescents about sexual health and experiences of racial discrimination, and how these experiences impact sexual health.

Behavioral: The Talk Web-based resources

Interventions

Educational videos and podcasts for parents and their sons

The TALK intervention for Black male adolescents and young adults (AYA)

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified as a parent, parent figure, or caregiver of a Black or African American male adolescent between the ages of 13-17 years, able to speak and read English. Adolescents of these parents will also be recruited along with their parents. Adolescents recruited will be required to sign additional consent forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Schenita Randolph, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 27, 2023

Study Start

May 1, 2023

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations