The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes

October 24, 2024 updated by: Ashley Philliber

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Accord, New York, United States, 12404
        • Philliber Research & Evaluation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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."
Behavioral: SkillTalk
Online Educator Mircoskill Training and Parent Microskill Training
Other Names:
  • SkillFlix
No Intervention: Business as usual
Business as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ashley Philliber

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Philliberdfusionparent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Pregnancy Prevention

Clinical Trials on SkillTalk

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings