Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06281171
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-02-20
Brief Title:
Evaluation of SkillTalk for Autistic Young Adults
Sponsor:
dfusion Inc
Organization:
dfusion Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 agenciesorganizations 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
Participants are primarily being recruited with assistance from agenciesorganizations 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None