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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT05675306
Eligibility Criteria:
Inclusion Criteria:
1. CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand \& McCauley, 2019),
2. 2;6-7;11 years of age at treatment commencement;
3. English as the primary language;
Exclusion Criteria:
1. concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
2. diagnosis of severe or primary dysarthria as described below;
3. palatal or structural orofacial anomalies as described below,
4. uncorrected vision impairment
5. hearing loss;
6. receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted
7. Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age,
8. Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds \& Kamphaus, 2015), and
9. no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Months
Maximum Age:
95 Years
Study:
NCT05675306
Study Brief:
Protocol Section:
NCT05675306