Clinical trial NCT05958394: Evaluation of Skillflix for Parents of Youth With ASD
Official title: Communication Training Around Sexual Health Topics for Parents of Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Autism Spectrum Disorder (ASD)
MicroSkills
Video training
Sexual and Reproductive Health
Parent Child Communication
Lead sponsor: Philliber Research & Evaluation
Sponsor class: OTHER
Collaborators: name: dfusion Inc
name: National Institutes of Health (NIH)
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Demonstrated Skill score in communicating with their teens about sexual health
timeFrame: 3 months
Secondary outcomes:
measure: Parent reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
timeFrame: 3 months
measure: Parent Conversation Quality Score
timeFrame: 3 months
measure: Parent confidence in their ability to use skills in communication with their teen about sexual health and relationships.
timeFrame: 3 months
measure: Parent confidence in teens ability to use Making Connections skills.
timeFrame: 3 months
measure: Teen reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
timeFrame: 3 months
measure: Youth Conversation Quality Score.
timeFrame: 3 months
measure: Teen confidence in their ability to use Making Connections skills.
timeFrame: 3 months
measure: Family Sex Communication Quotient Score
timeFrame: 3 months
measure: Teen's Sexual Health Knowledge
timeFrame: 3 months
measure: Teen's sexual health attitudes
timeFrame: 3 months
measure: Teen's sexual health behaviors
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: