- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05952973
The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes
The goal of this clinical trial is to evaluate the impact of SkillTalk among educators, parents, and students. The main question[s] it aims to answer are:
- What is the impact of SkillTalk on student sexual-health related outcomes?
- What is the impact of SkillTalk on educator microskills?
Educator participants will use an online microskills training platform for one week. Parent participants will be asked to use a parent-specific online microskills training platform for one week. Youth participants will not be asked to do anything outside of "business as usual." Researchers will compare the treatment groups to the control groups to measure the impact of SkillTalk.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Accord, New York, United States, 12404
- Philliber Research & Evaluation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Educators:
- Have fewer than three years teaching
- Teach youth in a class with at least 8 students
- Be able to obtain supervisor's or administration permission before beginning study
- Agree to be in compliance with district/school regulations about teaching sexual health and participating in a research study
- Agree to administer the assent/consent forms and student surveys.\
Inclusion Criteria for Students:
- Being in class of teacher who has agreed to participate
- Parental consent
- Assent to participate
Inclusion Criteria for Parents:
- Be the parent/guardian of a youth who has assented to participate
- Consent to their youth's participation
- Consent to view SkillTalk Parent site
- Need to speak English or Spanish
- Access to internet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SkillTalk
Educators in the treatment group will receive access to an online educator microskill training platform.
Parents/caregivers of students in the educators' classes will be assigned to treatment and receive access to a parent-specific online educator microskill training platform.
Students in this group will receive "business as usual."
|
Online Educator Mircoskill Training and Parent Microskill Training
Other Names:
|
|
No Intervention: Business as usual
Business as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Condom knowledge
Time Frame: 1 month
|
Students in the intervention group will show greater condom knowledge than students in the comparison group.
This will consist of a scale that will be knowledge questions specific to the steps of condom usage.
An overall score will be based on the percent correct.
A higher score would be a more positive outcome.
|
1 month
|
|
Condom use
Time Frame: 1 month
|
Students in the intervention group will show greater condom use self-efficacy than students in the comparison group.
This will consist of a scale created for this study.
This will be a self-efficacy scale using a 4-point strongly agree to strongly disagree scale.
For each of these a higher score would be a more positive outcome.
|
1 month
|
|
STI knowledge
Time Frame: 1 month
|
Students in the intervention group will show greater knowledge on STIs than students in the comparison group.
This will be based on knowledge questions specific to the information found in SkillTalk.
An overall score will be based on the percent correct.
A higher score would be a more positive outcome.
|
1 month
|
|
Connectedness
Time Frame: 1 month
|
Students in the intervention group will report greater feelings of connectedness with/perceived personalization of sexual health lesson messages than students in the comparison group.
This will be based on a four point strongly agree to strongly disagree scale with questions specific to the information found in SkillTalk.
An overall score will be based on the mean overall score of these questions.
A higher score would be a more positive outcome.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy and comfort with microskills
Time Frame: 1 month
|
Educators in the intervention group will report greater self-efficacy and comfort with condom and STI Microskills than educators in the comparison group.
This will be based on a four point strongly agree to strongly disagree scale with questions specific to the information found in SkillTalk.
An overall score will be based on the mean overall score of these questions.
A higher score would be a more positive outcome.
|
1 month
|
|
Student impressions of educator skills
Time Frame: 1 month
|
Students in the intervention group will report more positive perceptions of educator knowledge, skill, and comfort to teach sexual health lessons.
This will be based on a four point strongly agree to strongly disagree scale with questions specific to the information found in SkillTalk.
An overall score will be based on the mean overall score of these questions.
A higher score would be a more positive outcome.
|
1 month
|
|
Frequency of parent-child communication
Time Frame: 1 month
|
Parents in the intervention group will report more frequent communication about sexual health with their youth.
This will be based on a scale that will include daily, more than twice a week, twice per week, weekly, bi weekly, monthly, less than monthly, and never.
A greater frequency of communication would be a more positive outcome.
|
1 month
|
|
Comfort in parent-child communication
Time Frame: 1 month
|
Parents in the intervention group will report more comfort in communicating with their child about sexual health.
This will be based on a four point strongly agree to strongly disagree scale with questions specific to the information found in SkillTalk.
An overall score will be based on the mean overall score of these questions.
A higher score would be a more positive outcome.
|
1 month
|
|
Parent-child communication
Time Frame: 1 month
|
Parents in the intervention group will be perceived as better communicators by their children.
This will be based on a four point strongly agree to strongly disagree scale with questions specific to the information found in SkillTalk.
An overall score will be based on the mean overall score of these questions.
A higher score would be a more positive outcome.
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- Philliberdfusionparent
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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