- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315867
Better Social, Emotional Communication, Healthy Relationship and ASD Accommodation Skills: Emotional Intelligence ("EQ") Training for Autistic People and ASD Accommodation Training for People Who Care
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brian Sullivan, PhD
- Phone Number: 310-386-5242
- Email: brian@kairon.app
Study Locations
-
-
Pennsylvania
-
Wexford, Pennsylvania, United States, 15090
- Recruiting
- Training is all online and is available to participate in the study from anywhere in the US, run from a site in PA
-
Contact:
- Brian Sullivan, PhD
- Phone Number: 3103865242
- Email: brian@kairon.app
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Participants are enrolled in pairs consisting of an autistic adult and their learning partner. Autistic adult age requirement is 18-36 years and the learning partner age requirement is >18 years.
Autistic Adult Inclusion Criteria:
Generally healthy;
With a community diagnosis of ASD from a licensed clinician, such as a developmental pediatrician, psychiatrist, clinical psychologist, or a neurologist. Below is a set of valid example criteria these professionals could use, but other instruments, tools or diagnostic techniques could be used:
For example, meeting DSM-5 criteria for ASD based on a DSM-5 ASD symptom checklist (APA 2013); Meeting International Classification of Diseases (ICD-11) for ASD (code 6A02)(Kamp-Becker, 2024); or a score in the ASD range on the Autism Diagnostic Observation Schedule 2 (ADOS-20)(Lord et al., n.d.).
Participants have:
Sufficient linguistic capability and technology fluency and capability to participate in an all-online intervention and associated assessments; Their own computer hardware, software and internet connection to allow access to online training; Availability of a non-ASD parent, guardian or adult with a similarly strong and trusting relationship ("learning partner") who, upon pre-enrollment interview, has sufficient linguistic capability and technology fluency and capability to participate in an all-online intervention and associated assessments and the willingness, time and energy to keep up with the coursework; Absence of a clinical anxiety diagnosis, such as <70 score on the ASEBA ASR Anxiety Problems score (or equivalent) or not having sufficient anxiety to be clinically evaluated; Verbal IQ ≥ 90 from a community test or using the Self-Administered Verbal IQ Test (SA-VIQT)(Logos et al., n.d.; openpsychometrics.org, n.d.), which can be administered entirely online and has convergent validity with Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)(Wechsler, n.d.); and Ability to provide consent in English as a primary language with an absence of cognitive impairment.
Autistic Adult Exclusion Criteria:
Candidates will be ineligible for the study if they are Participating in other emotional intelligence, emotional communication or behavioral intervention training during the month of this intervention; Unable to devote at least an average of 15-30 minutes per day for 5 days per week, except one day off in the third week, to do the training plus two sets of 60-90 minute online questionnaires; or Unable to comply with study procedures or unwilling to accept the standard Kairon platform terms of use.
Learning Partner Inclusion Criteria:
Selected by an ASD adult enrolled in the study; Generally healthy; Without a diagnosis of ASD Sufficient linguistic capability and technology fluency and capability to participate in an all-online intervention and associated assessments; Their own computer hardware, software and internet connection to allow access to online training; Ability to provide consent in English as a primary language with an absence of cognitive impairment.
Learning Partner Exclusion Criteria:
Candidates will be ineligible for the study if they are Participating in other ASD accommodation training during the month of this intervention; Unable to devote at least an average of 15-30 minutes per day for 5 days per week, except one day off during the third week, to do the training plus two sets of 60-90 minute online questionnaires; or Unable to comply with study procedures or unwilling to accept the standard Kairon platform terms of use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Leadership training for autistic adult and autism accommodation training for learning partner
|
Leadership training consists of emotional literacy and healthy relationship elements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training effectiveness
Time Frame: 55-85 minutes before and after training
|
Surveys of each autistic adult measure the effectiveness of the leadership training they received and the effectiveness of the autism accommodation training their paired learning partner received.
Surveys of each learning partner measure the effectiveness of the autism accommodation they received and the effectiveness of the leadership training their paired autistic adult received.
|
55-85 minutes before and after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability
Time Frame: 5 minutes after training
|
Basic feedback on various aspects of the user experience during the training
|
5 minutes after training
|
|
Motivation
Time Frame: 5 minutes before training
|
Surveys of level of motivation from each participant
|
5 minutes before training
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1398838
- BISA25000689 (Other Grant/Funding Number: Administration for Community Living (ACL))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
Istituto per la Ricerca e l'Innovazione BiomedicaRecruitingAutism | Autism DisorderItaly
-
University of NottinghamUniversity Hospitals of Derby and Burton NHS Foundation Trust; Lincolnshire...Not yet recruitingAutism Spectrum Disorder | Autism | Parent | Autism Disorder | Autism in Children | Parent Stress | Parent Mental Health | Autism Disorders and Maternal Stress | Parent SupportUnited Kingdom
-
Boston Children's HospitalRecruitingAutism Spectrum Disorder | Autism | Autism DisorderUnited States
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Father Flanagan's Boys' HomeNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruitingAutism Spectrum Disorder | Autism | Autism, Susceptibility to, 6United States
-
Institut National de la Santé Et de la Recherche...Completed
-
Adia Med of Winter Park LLCActive, not recruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
Clinical Trials on Kairon leadership training for the autistic adult and Kairon autism accommodation training for the learning partner
-
Jesus VillarHospital Universitario Dr. Negrín (Las Palmas de Gran Canaria); Iinstituto...Active, not recruitingAcute Hypoxemic Respiratory FailureSpain