Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT05863520
Eligibility Criteria:
Inclusion Criteria: There are 3 groups of participants: students, caregivers and interdisciplinary school providers:
Inclusion criteria for students ages 8-14:
* known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
* clinical anxiety according to either student, parent or teacher report
* clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition (SRS-2).
Exclusion criteria for students
* known intellectual disability
* significant behavior or psychiatric challenge that prevents them from participation in small group activities
* lack of parent or caregiver permission for participation
Inclusion Criteria for Caregivers of students 8-14
\- legal guardian of a student who meets inclusion criteria defined above
Inclusion criteria for Interdisciplinary school providers (ISPs).
* degreed professionals in one of the following: education (special or general education), school psychology, counseling, social work, speech/language pathology, occupational or physical therapy OR paraprofessional who assist ISPs
* working with autistic students with anxiety
* be able to complete study requirements including attending the training workshops, delivering at least 80% of the program they were randomized to, and participating in 80% of bi-monthly consultation sessions with the research team.
Exclusion criteria ISPs
* if they are unable to participate in the trainings, deliver the program they are assigned to, or participate in any of the consultation visits
* if they do not work with students with autism and anxiety
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
15 Years
Study:
NCT05863520
Study Brief:
Protocol Section:
NCT05863520