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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03903120
Eligibility Criteria:
Inclusion Criteria:
1. Age between 4;0 and 9;11 (years;months) at enrollment, based on parent report.
2. From homes where the primary language spoken is English, based on parent report.
3. Verbal output (50+ words) and communicative intent, as determined by the clinician and parent report.
4. Speech sound disorder, as determined by a score \<16th percentile on the Diagnostic Evaluation of Articulation and Phonology (DEAP) Articulation Assessment (Dodd et al., 2006) and/or the Goldman-Fristoe Test of Articulation (Goldman \& Fristoe, 2015).
5. CAS as a primary speech diagnosis, based on the following criteria:
1. An average rating \> 1 across three expert speech-language pathologists (SLPs), who will independently rate presence of CAS in children live or from video recordings of the assessment using a 3-point scale (0 = no CAS, 1 = possible CAS, 2 = CAS). These judgments will be based on perceptual speech features of CAS (inconsistent vowel and consonant errors, difficulties achieving and transitioning into articulatory configurations, abnormal prosody).
2. An Apraxia Score of 1 or 2 on a Maximum Performance protocol in which they sustain vowels and fricatives as long as possible and repeat syllables as fast as possible (Rvachew et al., 2005; Thoonen et al., 1999).
6. Normal hearing based on parent report or passing a standard pure-tone audiometry hearing screening at 500, 1000, 2000, and 4000 Hz (ASHA, 1997).
7. Typical nonverbal cognition as determined by a T-score within 1.5 standard deviation (SD) of the mean on nonverbal subtests of the Reynolds Intellectual Assessment Scales (Reynolds \& Kamphaus, 2003).
Exclusion Criteria:
1. Diagnosis of disorder that significantly affects communication and/or social interactions (e.g., autism), as per referral diagnosis.
2. Uncorrected vision impairments that may interfere with ability to process visual cues used in treatment, as per parent report.
3. Significant impairments of oral structure (e.g., cleft palate) as judged by the SLP based on an oral mechanism exam (Robbins \& Klee, 1987).
4. A primary diagnosis of dysarthria, as judged by the SLP.
5. Unrelated health concerns that prevent children from participating, per parent report.
6. Inability to meet toileting needs independently or separate from parent for a full day (as needed for camp), based on parent report.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT03903120
Study Brief:
Protocol Section:
NCT03903120