Autism Spectrum DisorderNCT05958394
Evaluation of Skillflix for Parents of Youth With ASD
A study testing SkillFlix for Parents in people with Autism Spectrum Disorder, run by Ashley Philliber.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SkillFlix for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Communication Training Around Sexual Health Topics for Parents of Youth With Autism Spectrum Disorder
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:
Read more
- 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.
Read the 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
- Being tested
- SkillFlix for Parents
- Keywords
- Autism, Autism Spectrum Disorder (ASD), MicroSkills, Video training, Sexual and Reproductive Health, Parent Child Communication
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkillFlix for ParentsBehavioural
A Microskills video training library on communication skills for talking to youth about relationships and sexual health topics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Frequency will be broken down by topic into Relationships, Puberty, Public/Private, Sexual Health, Personal Safety, STIs.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Teen's sexual health behaviors
A series of questions about teens sexual health behaviors such as condom use, STI testing, and contraceptive use.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Nov 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashley Philliber
- Sponsor type
- University, hospital or other
- Collaborators
- dfusion Inc, National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Ashley Philliber, Philliber Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958394
- Sponsor's protocol ID
- R43ES024563
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Training Around Sexual Health Topics for Parents of Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05958394
- Acronym / sponsor ID
- R43ES024563
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Autism Spectrum Disorder (ASD), MicroSkills, Video training, Sexual and Reproductive Health, Parent Child Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ashley PhilliberUniversity, hospital or other
- Collaborators
- dfusion Inc, National Institutes of Health (NIH)
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: SkillFlix for ParentsThis 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. |
| 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible dyads will:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkillFlix for ParentsA Microskills video training library on communication skills for talking to youth about relationships and sexual health topics. | Behavioural | Treatment |
Primary outcome
Demonstrated Skill score in communicating with their teens about sexual health
Time frame: 3 months
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.
11 secondary outcomes
Parent reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
Time frame: 3 months
Parent Conversation Quality Score
Time frame: 3 months
Parent confidence in their ability to use skills in communication with their teen about sexual health and relationships.
Time frame: 3 months
Parent confidence in teens ability to use Making Connections skills.
Time frame: 3 months
Teen reported frequency of discussions with their teens about sexual health and relationships over the course of the last 3 months.
Time frame: 3 months
Youth Conversation Quality Score.
Time frame: 3 months
Teen confidence in their ability to use Making Connections skills.
Time frame: 3 months
Family Sex Communication Quotient Score
Time frame: 3 months
Teen's Sexual Health Knowledge
Time frame: 3 months
Teen's sexual health attitudes
Time frame: 3 months
Teen's sexual health behaviors
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing SkillFlix for Parents in people with Autism Spectrum Disorder, run by Ashley Philliber.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley Philliber, PhD (9739000739, aphilliber@philliberresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrated Skill score in communicating with their teens about sexual health (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.