Evaluation of Skillflix for Parents of Youth With ASD

NCT ID: NCT05958394

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-03-31

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.

Detailed Description

The proposed project will establish the efficacy of using the SkillFlix for Parents online video library to improve the sexual health communication skills of parents of teens with autism spectrum disorder. A randomized controlled trial is being conducted to assess the impact of the resource on parent skill demonstration and confidence, conversation frequency, and teen knowledge, attitudes, and behaviors. Participants will be parent and youth dyads, including parents over 18 years old and youth aged 13-17 with ASD, reciprocal communication skills, receptive language skills, who are in mainstream classrooms for at least one class during the school day.

Participants are primarily being recruited with assistance from agencies/organizations that serve those with ASD, community and professional advisory board members, and other community networks. It is also likely that participants will refer other parents of youth on the spectrum for participation.

The study design will be a randomized controlled trial of dyads with pre- and post-assessment, and a 3-month follow-up assessment (6 months after start of study), each including a survey and audio recording. After completing the baseline activities, half (50) of the dyads will be randomly assigned to the SkillTalk ASD intervention group which will receive access to the SkillTalk ASD web site and the study mobile app. The control group will receive written materials with similar content. For baseline parents will take a survey, audio record a conversation based on a written conversation guide and upload it for analysis. Youth will take a survey. Intervention participants will have access to SkillTalk ASD for 3 months. During the three-month period, parent and youth participants will be asked to complete a bi-weekly conversation log. At the conclusion of the three-month period, they will participate in an immediate post-test which will again include a survey, audio record a conversation based on a written conversation guide and upload it for analysis. Youth will take an immediate post-test survey. During the three-month follow-up period, parents and youths will be asked to complete a biweekly conversation log. Three months after the conclusion of the access period parents will take a survey, audio record a conversation based on a written conversation guide and upload it for analysis. Youth will take a survey. At the conclusion of the 6-month period the control group participants will be provided with access to the SkillFlix ASD materials.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

SkillFlix for Parents

Intervention Type: BEHAVIORAL

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

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SkillFlix for Parents

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• There will be no exclusionary criteria based on gender or race/ethnicity, however during recruitment and enrollment staff will try to ensure that the race/ethnicity demographics reflect those of the U.S. more generally, with a 10% oversampling for Black and Latinx participants, and the gender ratio is balanced. Parent participants will not be screened for or included/excluded on the basis of having ASD themselves.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

dfusion Inc

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Ashley Philliber

OTHER

Sponsor Role: lead

Responsible Party

Ashley Philliber

Managing Director

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ashley Philliber, PhD

Role: CONTACT

aphilliber@philliberresearch.com

9739000739

Other Identifiers

R43ES024563

Identifier Type: -

Identifier Source: org_study_id