NCT05952973

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

July 5, 2023

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Condom knowledge

    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

    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

    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

    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 Outcomes (5)

  • Self-efficacy and comfort with microskills

    1 month

  • Student impressions of educator skills

    1 month

  • Frequency of parent-child communication

    1 month

  • Comfort in parent-child communication

    1 month

  • Parent-child communication

    1 month

Study Arms (2)

SkillTalk

EXPERIMENTAL

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

Business as usual

NO INTERVENTION

Business as usual.

Interventions

SkillTalkBEHAVIORAL

Online Educator Mircoskill Training and Parent Microskill Training

Also known as: SkillFlix
SkillTalk

Eligibility Criteria

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

You may qualify if:

  • 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.\\
  • Being in class of teacher who has agreed to participate
  • Parental consent
  • Assent to participate
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philliber Research & Evaluation

Accord, New York, 12404, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Managing Director

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 19, 2023

Study Start

April 15, 2023

Primary Completion

August 24, 2024

Study Completion

October 24, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations