NCT06281171

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 21, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

February 20, 2024

Results QC Date

February 26, 2025

Last Update Submit

May 2, 2025

Conditions

Keywords

ASDAutismMicroskillsVideo TrainingCommunication SkillsYoung Adult

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Participant Confidence & Satisfaction in Their Communication Skills

    Baseline (T1), 1 month (T2), and 4 months (T3)

  • Interpersonal Competence Score

    Baseline (T1), 1 month (T2), and 4 months (T3)

  • Coping With Rejection, Jealousy and Relationship Anxiety

    Baseline (T1), 1 month (T2), and 4 months (T3)

  • PROMIS Depression Scale T-Scores

    Baseline (T1), 1 month (T2), and 4 months (T3)

  • Promise Anxiety Scale

    Baseline (T1), 1 month (T2), and 4 months (T3)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Flyer Library

Interventions

A Microskills video training library on communication skills for autistic young adults.

Video Library Group

A collection of existing online resources on relationship skills

Flyer Library Group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virtual Study

Santa Cruz, California, 95060, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

One of the outcomes Skill Score: Compromise, posed significant challenges during the roleplay and coding stages. We were not able to reflect the full complexity of this in the roleplay scenarios, which resulted in an overly simple scenario. Scores were consistently high across all time points and across both groups, meaning that we ran into a ceiling effect and did not see significant change.

Results Point of Contact

Title
Lane Edwards, MPH, Project Director
Organization
dfusion Inc.

Study Officials

  • Regina Firpo-Triplett, MPH

    dfusion Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

March 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

May 21, 2025

Results First Posted

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.

Locations