NCT05958394

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for training parents of adolescents with ASD in talking with their teens about relationships and sexual health topics. The main questions it aims to answer are:

  • Does using SkillTalk increase parents' skills in communicating with their teens about relationships and sexual health?
  • Does using SkillTalk increase the frequency of conversations about relationships and sexual health?
  • Does using SkillTalk increase parents' confidence in their ability to communicate with their teens about relationships and sexual health?
  • Does using SkillTalk improve teen knowledge, attitudes, and behavior around sexual health and relationships? Participants will be asked to:
  • Take a survey at the beginning of the study, the end of the study, and at 3-month follow up
  • Record a short conversation between the parent and teen dyad about a sexual health topic at the beginning of the study, at the end of the study, and at 3-month follow up.
  • Watch a minimum of 85% of the 60 minutes of video assigned
  • Complete a conversation log at the end of each week during the study period, and once a month during the 3-month follow-up period.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

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

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 14, 2023

Last Update Submit

July 14, 2023

Conditions

Keywords

AutismAutism Spectrum Disorder (ASD)MicroSkillsVideo trainingSexual and Reproductive HealthParent Child Communication

Outcome Measures

Primary Outcomes (1)

  • Demonstrated Skill score in communicating with their teens about sexual health

    Based on a rubric created for this study of the demonstrable skills for the given recorded conversation topic. The points earned on the rubric are summed to create a total score. The scale ranges from 0 to 20 with a higher score indicating higher skill usage.

    3 months

Secondary Outcomes (11)

  • Parent reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.

    3 months

  • Parent Conversation Quality Score

    3 months

  • Parent confidence in their ability to use skills in communication with their teen about sexual health and relationships.

    3 months

  • Parent confidence in teens ability to use Making Connections skills.

    3 months

  • Teen reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.

    3 months

  • +6 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

This arm will receive the intervention. This intervention is access to the SkillFlix for Parents Microskills video library, about 60 minute in duration. The library includes a curriculum covering skills such as seizing teachable moments, talking about identities, and using a conversation tone.

Behavioral: SkillFlix for Parents

Control

NO INTERVENTION

During the intervention period arm 2 will receive written conversation guides for the assigned conversations. This arm will receive the intervention upon completion of follow-up study activities.

Interventions

A Microskills video training library on communication skills for talking to youth about relationships and sexual health topics.

Treatment

Eligibility Criteria

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

You may qualify if:

  • Eligible dyads will:
  • Have a parent of youth aged 13-17 with diagnosed ASD.
  • Have a child aged 13-17 with ASD. The child must:
  • have reciprocal communication skills and receptive communication skills
  • be in mainstream classrooms for a minimum of one class during the school day
  • Have access to a computer/mobile device connected to the internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderCoitus

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSexual BehaviorBehavior

Central Study Contacts

Ashley Philliber, PhD

CONTACT

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 14, 2023

First Posted

July 24, 2023

Study Start

November 15, 2023

Primary Completion

January 30, 2024

Study Completion

March 31, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share