Autism Spectrum DisorderNCT06281171
Evaluation of SkillTalk for Autistic Young Adults
A study testing SkillTalk for Autistic Young Adults and Flyer Library in people with Autism Spectrum Disorder, run by dfusion Inc at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SkillTalk for Autistic Young Adults and Flyer Library
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- young adults, aged 18-28
- have ASD, with
- reciprocal communication skills and receptive language skills.
- Eligibility will be determined by study staff with screener questions posed to the participants about their age, ASD status (self-report based on self-determination), and comfort with the study activities.
Who cannot join
- Interested individuals participate in a consent screening call where they are asked to answer four simple questions about the information provided in the consent form. Participants who are unable to answer these questions correctly after prompting from study staff are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SkillTalk: Using Streaming Video for Young Adults With Autism Spectrum Disorder to Build Microskills to Develop and Sustain Relationships for Healthy and Independent Living Spectrum Disorder
The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.
The main questions it aims to answer are:
Read more
- Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?
- Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?
- Does using SkillTalk increase interpersonal competence?
- Does using SkillTalk increase ability to cope with rejection?
- Does using SkillTalk improve mental health and wellbeing?
Participants will be asked to:
- Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up
- Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up
- Watch a minimum of 85% of the 60 minutes of video assigned
Read the detailed description
The proposed project will establish the efficacy of using SkillTalk for Autistic Young Adults online video library to improve the relationship and communication skills of young adults on the autism spectrum. A randomized controlled trial is being conducted to assess the impact of the resource on participant skill demonstration and confidence, interpersonal competence, mental health and wellbeing. Participants will be young adults, aged 18-28, have ASD, with reciprocal communication skills and receptive language skills. Participants with diagnosed intellectual disabilities will be excluded from the study.
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 autistic young adults participation.
The study design will be a randomized controlled trial with pre- and post-assessment, and a 3-month follow-up assessment (4 months after start of study), each including a survey and a facilitated roleplay via video call. After completing the baseline activities, half (55) of the participants will be randomly assigned to the SkillTalk AYA intervention group which will receive access to the SkillTalk AYA web site. The control group will receive written materials with similar content. For baseline, participants will take a survey and take part in a brief facilitated role play of 3 simple relationship scenarios, one on one with a project staff member. Intervention participants will have access to SkillTalk AYA for 1 month. At the conclusion of the month period, they will participate in an immediate post-test which will again include a survey and a facilitated role play session. Three months after the conclusion of the access period participants will take a survey and take part in a final role play session. At the conclusion of the 4-month period the control group participants will be provided with access to the SkillTalk AYA materials.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SkillTalk for Autistic Young Adults, Flyer Library
- Keywords
- ASD, Autism, Microskills, Video Training, Communication Skills, Young Adult
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkillTalk for Autistic Young AdultsOther
A Microskills video training library on communication skills for autistic young adults.
Flyer LibraryOther
A collection of existing online resources on relationship skills
| Study group | Role | What they receive |
|---|---|---|
| Video Library Group | Experimental | This arm will receive the intervention. This intervention is access to the SkillTalk for AYA Microskills video library, about 60 minutes in duration. The library includes a curriculum covering skills such as setting boundaries, resolving conflict, and emotional regulation. Receives: Other: SkillTalk for Autistic Young Adults |
| Flyer Library Group | Active comparator | During the intervention period, arm 2 will receive flyers with information on relationship skills. This arm will receive the intervention upon completion of follow-up study activities. Receives: Other: Flyer Library |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrated Skill Score in Communication Skills.
Based on a rubric created for this study of the demonstrable skills for the given recorded roleplay conversation. The points earned on the rubric are summed to create a total score. The scale ranges from 0 to 160 with a higher score indicating higher skill usage.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
Secondary outcomes (6)
Participant Confidence & Satisfaction in Their Communication Skills
Based on a scale created for the study, the score is comprised of a series of questions about ability to navigate social situations with friends, partners, and acquaintances. The scores from the question are summed to create a total score. The score range is 24 to 120, with higher scores indicating more confidence in ability.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
Interpersonal Competence Score
Based on the ICQ; Buhrmester et al, 1988. 40-item scale includes subscales: Initiating relationships, self-disclosure, asserting displeasure with others' actions, providing emotional support, and managing interpersonal conflicts. Respondents use a 5-point rating scale to indicate their level of competence and comfort in handling each type of situation (from 1 = "I'm poor at this; I'd feel so uncomfortable and unable to handle this situation, I'd avoid it if possible" to 5 = I'm EXTREMELY good at this; I'd feel very comfortable and could handle this situation very well"). The scores from the question are summed to create a total score. The score range is between 40 and 200. Higher values indicate more communication competence.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
Coping With Rejection, Jealousy and Relationship Anxiety
Based on a scale by Rothman, Holmes et al 2022. The 16-item scale assessing how participants manage rejection and jealousy. Respondents use a 5-point rating scale to indicate the degree to which they agree with each statement. Add points for each item to create a total scale score. If a respondent skipped two more items, do not score. The score ranges between 16-80. Higher scores indicate better coping with jealousy.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
PROMIS Depression Scale T-Scores
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Short Form. This adult measure is the 8-item PROMIS Depression Short Form that assesses the pure domain of depression in individuals age 18 and older. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. These raw scores are summed and converted to a T-Score. For the T-Score a higher score indicates greater severity of depression. Generally, a T-score below 55 is considered normal, 55-60 is mild, 60-70 is moderate, and 70 or higher is severe. PROMIS T-scores are standardized to a mean of 50 and a standard deviation of 10.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
Promise Anxiety Scale
Adult measure is the 7-item PROMIS Anxiety Short Form that assesses the pure domain of anxiety in individuals age 18 and older. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
PROMIS Life Satisfaction Scale T-Scores
PROMIS (Patient-Reported Outcomes Measurement Information System) Life Satisfaction Short Form is a 5-item for that assesses one's cognitive evaluation of life experiences and whether one likes his/her life or not. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). The raw scores are summed and converted to the corresponding T-Score. PROMIS uses T-scores with a population mean of 50 and a standard deviation of 10. A higher score represents more life satisfaction.
Measured: Baseline (T1), 1 month (T2), and 4 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- dfusion Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regina Firpo-Triplett, MPH, Principal investigator, dfusion Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281171
- Sponsor's protocol ID
- 90BISB0022
- Status last verified
- May 2025
- First submitted
- 20 Feb 2024
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SkillTalk: Using Streaming Video for Young Adults With Autism Spectrum Disorder to Build Microskills to Develop and Sustain Relationships for Healthy and Independent Living Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06281171
- Acronym / sponsor ID
- 90BISB0022
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Autism, Microskills, Video Training, Communication Skills, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- dfusion IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Posted 21 May 2025
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 young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.
The main questions it aims to answer are:
- Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?
- Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?
- Does using SkillTalk increase interpersonal competence?
- Does using SkillTalk increase ability to cope with rejection?
- Does using SkillTalk improve mental health and wellbeing?
Participants will be asked to:
- Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up
- Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up
- Watch a minimum of 85% of the 60 minutes of video assigned
Detailed description
The proposed project will establish the efficacy of using SkillTalk for Autistic Young Adults online video library to improve the relationship and communication skills of young adults on the autism spectrum. A randomized controlled trial is being conducted to assess the impact of the resource on participant skill demonstration and confidence, interpersonal competence, mental health and wellbeing. Participants will be young adults, aged 18-28, have ASD, with reciprocal communication skills and receptive language skills. Participants with diagnosed intellectual disabilities will be excluded from the study.
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 autistic young adults participation.
The study design will be a randomized controlled trial with pre- and post-assessment, and a 3-month follow-up assessment (4 months after start of study), each including a survey and a facilitated roleplay via video call. After completing the baseline activities, half (55) of the participants will be randomly assigned to the SkillTalk AYA intervention group which will receive access to the SkillTalk AYA web site. The control group will receive written materials with similar content. For baseline, participants will take a survey and take part in a brief facilitated role play of 3 simple relationship scenarios, one on one with a project staff member. Intervention participants will have access to SkillTalk AYA for 1 month. At the conclusion of the month period, they will participate in an immediate post-test which will again include a survey and a facilitated role play session. Three months after the conclusion of the access period participants will take a survey and take part in a final role play session. At the conclusion of the 4-month period the control group participants will be provided with access to the SkillTalk AYA materials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Library Group | Experimental | Other: SkillTalk for Autistic Young AdultsThis arm will receive the intervention. This intervention is access to the SkillTalk for AYA Microskills video library, about 60 minutes in duration. The library includes a curriculum covering skills such as setting boundaries, resolving conflict, and emotional regulation. |
| Flyer Library Group | Active comparator | Other: Flyer LibraryDuring the intervention period, arm 2 will receive flyers with information on relationship skills. This arm will receive the intervention upon completion of follow-up study activities. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- young adults, aged 18-28
- have ASD, with
- reciprocal communication skills and receptive language skills.
- Eligibility will be determined by study staff with screener questions posed to the participants about their age, ASD status (self-report based on self-determination), and comfort with the study activities.
Key exclusion criteria (1 listed)
- Interested individuals participate in a consent screening call where they are asked to answer four simple questions about the information provided in the consent form. Participants who are unable to answer these questions correctly after prompting from study staff are excluded from the study.
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 |
|---|---|---|
| SkillTalk for Autistic Young AdultsA Microskills video training library on communication skills for autistic young adults. | Other | Video Library Group |
| Flyer LibraryA collection of existing online resources on relationship skills | Other | Flyer Library Group |
Primary outcome
Demonstrated Skill Score in Communication Skills.
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
Based on a rubric created for this study of the demonstrable skills for the given recorded roleplay conversation. The points earned on the rubric are summed to create a total score. The scale ranges from 0 to 160 with a higher score indicating higher skill usage.
6 secondary outcomes
Participant Confidence & Satisfaction in Their Communication Skills
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
Interpersonal Competence Score
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
Coping With Rejection, Jealousy and Relationship Anxiety
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
PROMIS Depression Scale T-Scores
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
Promise Anxiety Scale
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
PROMIS Life Satisfaction Scale T-Scores
Time frame: Baseline (T1), 1 month (T2), and 4 months (T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.
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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.
Regina Firpo-Triplett, MPH principal investigator
dfusion Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkillTalk for Autistic Young Adults and Flyer Library in people with Autism Spectrum Disorder, run by dfusion Inc at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrated Skill Score in Communication Skills. (time frame: Baseline (T1), 1 month (T2), and 4 months (T3)). 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 21 May 2025.