Evaluation of SkillTalk for Autistic Young Adults

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:

• 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

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: SkillTalk for Autistic Young Adults; Other: Flyer Library

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Cruz, California, United States, 95060
      • Virtual Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Library Group; 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.	Other: SkillTalk for Autistic Young Adults; A Microskills video training library on communication skills for autistic young adults.
Active Comparator: Flyer Library Group; 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.	Other: Flyer Library; A collection of existing online resources on relationship skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T1), 1 month (T2), and 4 months (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline (T1), 1 month (T2), and 4 months (T3)

Collaborators and Investigators

• Sponsor: dfusion Inc
• Investigators: Principal Investigator: Regina Firpo-Triplett, MPH, dfusion Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ASD; Autism; Young Adult; Communication Skills; Microskills; Video Training
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 90BISB0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No