Evaluation of SkillTalk for Autistic Young Adults

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06281171
• Other study ID #: 90BISB0022
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: dfusion Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• SkillTalk for Autistic Young Adults
A Microskills video training library on communication skills for autistic young adults.
• Flyer Library
A collection of existing online resources on relationship skills

Locations

Country	Name	City	State
United States	Virtual Study	Santa Cruz	California

Sponsors (1)

Lead Sponsor	Collaborator
dfusion Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 20 with a higher score indicating higher skill usage.	Baseline, 1 month, and 4 months
Secondary	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, 1 month, and 4 months
Secondary	Interpersonal Competence Score	Based on the ICQ; Buhrmester et al, 1988. The 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 18 and 90. Higher values indicate more communication competence.	Baseline, 1 month, and 4 months
Secondary	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, 1 month, and 4 months
Secondary	Mental Health and Wellbeing	Based on PROMIS subscales for depression, anxiety, anger, social isolation, self-efficacy for managing emotions, and general life satisfaction. The score ranges between 26-130. Higher scores indicate better wellbeing.	Baseline, 1 month, and 4 months