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Evaluation of Skillflix for Parents of Youth With ASD

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SkillFlix for Parents
Sponsored by
Ashley Philliber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Autism, Autism Spectrum Disorder (ASD), MicroSkills, Video training, Sexual and Reproductive Health, Parent Child Communication

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Parent reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
    Frequency will be broken down by topic into Relationships, Puberty, Public/Private, Sexual Health, Personal Safety, STIs.
    Parent Conversation Quality Score
    Based on a scale created for this study, the Conversation Quality Score is comprised of a series of conversation log questions about teen engagement and perceived effectiveness of the conversation. The scores from the question are summed to create a total score. The score range is 3 to 15 with higher scores indicating a high quality of conversation.
    Parent confidence in their ability to use skills in communication with their teen about sexual health and relationships.
    Based on a scale created for the study, the score is comprised of a series of questions about ability to discuss safer sex topics, use a conversational tone, practice active listening, answer questions, and navigate teen readiness. The scores from the question are summed to create a total score. The score range is 5 to 25, with higher scores indicating more confidence in ability.
    Parent confidence in teens ability to use Making Connections skills.
    Based on a scale created for the study, the score is comprised of a series of questions about ability to use effective communication techniques with trusted adults, have challenging conversations with adults, seize askable moments, and establish boundaries. The scores from the question are summed to create a total score. The score range is 4 to 20, with higher scores indicating more confidence in ability.
    Teen reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
    Frequency will be broken down by topic into Relationships, Puberty, Public/Private, Sexual Health, Personal Safety, STIs.
    Youth Conversation Quality Score.
    Based on a simple 5 point rating system. The score range is 1-5, with higher scores indicating higher quality conversation.
    Teen confidence in their ability to use Making Connections skills.
    Based on a scale created for the study, the score is comprised of a series of questions about ability to use effective communication techniques with trusted adults, have challenging conversations with adults, seize askable moments, and establish boundaries. The scores from the question are summed to create a total score. The score range is 4 to 20, with higher scores indicating more confidence in ability.
    Family Sex Communication Quotient Score
    Based on a scale developed as a diagnostic tool to measure a general family orientation to discussion about sex between parents and children (Warren & Neer, 1982, 1983). The scores from the question are summed to create a total score. The score range is 18 to 90, with higher scores indicating high communication orientation.
    Teen's Sexual Health Knowledge
    Based on a scale created for this study, this score is comprised of a series of questions about the sexual health topics discussed in the recorded conversations. The scores from the question are summed to create a total score. The scale ranges from 0 to 5 with a higher score indicating greater knowledge.
    Teen's sexual health attitudes
    Based on a scale created for this study, this score is comprised of a series of questions about teens comfort regarding sexual health topics. The scores from the question are summed to create a total score. The scale ranges from 2 to 10 with a higher score indicating greater comfort.
    Teen's sexual health behaviors
    A series of questions about teens sexual health behaviors such as condom use, STI testing, and contraceptive use.

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 14, 2023
    Sponsor
    Ashley Philliber
    Collaborators
    dfusion Inc, National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05958394
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2024 (Anticipated)
    Study Completion Date
    March 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ashley Philliber
    Collaborators
    dfusion Inc, National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Autism, Autism Spectrum Disorder (ASD), MicroSkills, Video training, Sexual and Reproductive Health, Parent Child Communication

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SkillFlix for Parents
    Intervention Description
    A Microskills video training library on communication skills for talking to youth about relationships and sexual health topics.
    Primary Outcome Measure Information:
    Title
    Demonstrated Skill score in communicating with their teens about sexual health
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Parent reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
    Description
    Frequency will be broken down by topic into Relationships, Puberty, Public/Private, Sexual Health, Personal Safety, STIs.
    Time Frame
    3 months
    Title
    Parent Conversation Quality Score
    Description
    Based on a scale created for this study, the Conversation Quality Score is comprised of a series of conversation log questions about teen engagement and perceived effectiveness of the conversation. The scores from the question are summed to create a total score. The score range is 3 to 15 with higher scores indicating a high quality of conversation.
    Time Frame
    3 months
    Title
    Parent confidence in their ability to use skills in communication with their teen about sexual health and relationships.
    Description
    Based on a scale created for the study, the score is comprised of a series of questions about ability to discuss safer sex topics, use a conversational tone, practice active listening, answer questions, and navigate teen readiness. The scores from the question are summed to create a total score. The score range is 5 to 25, with higher scores indicating more confidence in ability.
    Time Frame
    3 months
    Title
    Parent confidence in teens ability to use Making Connections skills.
    Description
    Based on a scale created for the study, the score is comprised of a series of questions about ability to use effective communication techniques with trusted adults, have challenging conversations with adults, seize askable moments, and establish boundaries. The scores from the question are summed to create a total score. The score range is 4 to 20, with higher scores indicating more confidence in ability.
    Time Frame
    3 months
    Title
    Teen reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
    Description
    Frequency will be broken down by topic into Relationships, Puberty, Public/Private, Sexual Health, Personal Safety, STIs.
    Time Frame
    3 months
    Title
    Youth Conversation Quality Score.
    Description
    Based on a simple 5 point rating system. The score range is 1-5, with higher scores indicating higher quality conversation.
    Time Frame
    3 months
    Title
    Teen confidence in their ability to use Making Connections skills.
    Description
    Based on a scale created for the study, the score is comprised of a series of questions about ability to use effective communication techniques with trusted adults, have challenging conversations with adults, seize askable moments, and establish boundaries. The scores from the question are summed to create a total score. The score range is 4 to 20, with higher scores indicating more confidence in ability.
    Time Frame
    3 months
    Title
    Family Sex Communication Quotient Score
    Description
    Based on a scale developed as a diagnostic tool to measure a general family orientation to discussion about sex between parents and children (Warren & Neer, 1982, 1983). The scores from the question are summed to create a total score. The score range is 18 to 90, with higher scores indicating high communication orientation.
    Time Frame
    3 months
    Title
    Teen's Sexual Health Knowledge
    Description
    Based on a scale created for this study, this score is comprised of a series of questions about the sexual health topics discussed in the recorded conversations. The scores from the question are summed to create a total score. The scale ranges from 0 to 5 with a higher score indicating greater knowledge.
    Time Frame
    3 months
    Title
    Teen's sexual health attitudes
    Description
    Based on a scale created for this study, this score is comprised of a series of questions about teens comfort regarding sexual health topics. The scores from the question are summed to create a total score. The scale ranges from 2 to 10 with a higher score indicating greater comfort.
    Time Frame
    3 months
    Title
    Teen's sexual health behaviors
    Description
    A series of questions about teens sexual health behaviors such as condom use, STI testing, and contraceptive use.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashley Philliber, PhD
    Phone
    9739000739
    Email
    aphilliber@philliberresearch.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Skillflix for Parents of Youth With ASD

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