Clinical trial NCT06281171: Evaluation of SkillTalk for Autistic Young Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Autism
Microskills
Video Training
Communication Skills
Young Adult
Lead sponsor: dfusion Inc
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demonstrated Skill Score in Communication Skills.
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
Secondary outcomes:
measure: Participant Confidence & Satisfaction in Their Communication Skills
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
measure: Interpersonal Competence Score
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
measure: Coping With Rejection, Jealousy and Relationship Anxiety
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
measure: PROMIS Depression Scale T-Scores
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
measure: Promise Anxiety Scale
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
measure: PROMIS Life Satisfaction Scale T-Scores
timeFrame: Baseline (T1), 1 month (T2), and 4 months (T3)
Other outcomes:
Locations:
city: Santa Cruz
country: United States
facility: Virtual Study
state: California
Study officials:
affiliation: dfusion Inc
name: Regina Firpo-Triplett, MPH
role: PRINCIPAL_INVESTIGATOR
References: