Sexuality EducationNCT05746585
The TALK for Black Male Adolescent Sexual Health
A study testing The Talk Web-based resources in people with Sexuality Education, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexuality Education
- What is being tested?
- The Talk Web-based resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The TALK; A Novel Nurse-led, Family-based Web-based Application Marketed in Barbershops and Beauty Salons for Black Fathers and Mothers to Promote Sexual Health Among Black Male Adolescents and Young Adults in the United States
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.
- Conditions
- Sexuality Education
- Being tested
- The Talk Web-based resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Talk Web-based resourcesBehavioural
Educational videos and podcasts for parents and their sons
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Talk Web-based resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Usability of The TALK as measured by number of website uses
Measured: 6 months
Acceptability
Acceptability of The TALK as measured by participant survey feedback
Measured: 6 months
Communication Frequency
Frequency of parent-adolescent sexual health communication measured by survey feedback
Measured: 6 months
Communication Quality
Quality of parent-adolescent sexual health communication as measured by survey feedback
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 May 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexuality EducationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Schenita Randolph, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746585
- Sponsor's protocol ID
- Pro00105116
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TALK; A Novel Nurse-led, Family-based Web-based Application Marketed in Barbershops and Beauty Salons for Black Fathers and Mothers to Promote Sexual Health Among Black Male Adolescents and Young Adults in the United States
- ClinicalTrials.gov ID
- NCT05746585
- Acronym / sponsor ID
- Pro00105116
- Conditions
- Sexuality Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The TALK intervention for Black male adolescents and young adults (AYA) | Experimental | Behavioral: The Talk Web-based resourcesThe 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Talk Web-based resourcesEducational videos and podcasts for parents and their sons | Behavioural | The TALK intervention for Black male adolescents and young adults (AYA) |
Primary outcome
Usability
Time frame: 6 months
Usability of The TALK as measured by number of website uses
Acceptability
Time frame: 6 months
Acceptability of The TALK as measured by participant survey feedback
Communication Frequency
Time frame: 6 months
Frequency of parent-adolescent sexual health communication measured by survey feedback
Communication Quality
Time frame: 6 months
Quality of parent-adolescent sexual health communication as measured by survey feedback
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schenita Randolph, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Talk Web-based resources in people with Sexuality Education, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.