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:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT05277103
Eligibility Criteria:
Inclusion Criteria:
* Children with ASD (N=40) between 3 to 6 years of age; diagnosis confirmed based on DSM-V criteria (APA, 2013) and administration of the Autism Diagnostic Observational Schedule-2 (ADOS-2; Lord et al., 2012).
* minimally verbal defined as less than 20 functional, spontaneous words, signs, or symbols
* currently using or a candidate for a SGD to augment communication
* symbol discrimination skills based on pre-treatment assessment with an adult partner using a matching-to-sample procedure and a minimum choice of one preferred item and one foil
* English as the primary language spoken at home.
Exclusion criteria:
* co-morbid or previously identified genetic conditions associated with ASD (e.g., Fragile X)
* visual impairment, deafness, or other sensory disabilities
* a lack of symbol discrimination skills
Peer Partners:
* ages of 3 and 6 years (N=80 total over 2 years).
* recommended by school staff based on meeting six of the eight following criteria: 1) follows simple 2-step directions, (2) responds positively to adult requests to modify or change undesirable behaviors, (3) appropriately approaches and invites other children to play, (4) is comfortable talking to and interacting with other children while playing, (5) takes turns and shares toys with other children, (6) offers to help other children set up play routines or complete tasks, (7) is well-liked by many children in the classroom, and (8) will stay and play with other children for an appropriate length of time.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
6 Years
Study:
NCT05277103
Study Brief:
Protocol Section:
NCT05277103