Phase 1
Completed N=39
ASSIST: Treatment for Childhood Apraxia of Speech
Childhood Apraxia of Speech
Source: ClinicalTrials.gov NCT03903120 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Speech Accuracy of Treated Items — -0.7; 10.6; -2.8; -1.4 percentage of accuracy (change score) — p=0.0001
Summary
Childhood apraxia of speech (CAS) is a pediatric motor speech disorder that impairs the planning of movements needed for intelligible speech. Children with CAS often show little or slow progress in standard speech therapy. This research is a Phase 1 study that tests initial efficacy and optimal parameters of a theoretically based integral stimulation treatment called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment). In four small randomized group design studies across three recruitment cycles (N=20 per cycle), children receive 16 hours of individual ASSIST. The studies systematically investigate the effect of treatment (ASSIST vs. no ASSIST; Study 1), the effect of complexity (complex vs. simple utterances; Study 2), the effect of lexicality (word vs. nonword targets; Study 3), and the effect of treatment intensity (Massed vs. Distributed ASSIST; Study 4). Studies 1 and 4 also systematically examine the effect of treatment on functional outcome measures, including parent ratings of intelligibility and communicative participation, and objective intelligibility measures obtained from unfamiliar listeners.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Accuracy of Treated Items |
-0.7; 10.6; -2.8; -1.4; 13.9; 14.7 | 0.0001 sig |
| SECONDARY Speech Accuracy of Untreated Generalization Items |
0.3; 5.9; 1.0; 0.9; 4.9; 5.1 | 0.0697 |
| SECONDARY ICS Average Score (Intelligibility-in-Context Scale) |
0.358; 0.183; 0.155; 0.250; 0.381; 0.464 | 0.0806 |
| SECONDARY FOCUS-34 Total Score |
0.807; 0.288; 0.2500; 1.0120; 0.394; 0.339 | 0.3012 |
| SECONDARY TOCS+ Intelligibility (Percentage Words Correctly Understood) Change Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age between 4;0 and 9;11 (years;months) at enrollment, based on parent report.
- From homes where the primary language spoken is English, based on parent report.
- Verbal output (50+ words) and communicative intent, as determined by the clinician and parent report.
- Speech sound disorder, as determined by a score 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).
- 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).
- Normal hearing based on parent report or passing a standard pure-tone audiometry hearing screening at 500, 1000, 2000, and 4000 Hz (ASHA, 1997).
- 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
- Diagnosis of disorder that significantly affects communication and/or social interactions (e.g., autism), as per referral diagnosis.
- Uncorrected vision impairments that may interfere with ability to process visual cues used in treatment, as per parent report.
- Significant impairments of oral structure (e.g., cleft palate) as judged by the SLP based on an oral mechanism exam (Robbins & Klee, 1987).
- A primary diagnosis of dysarthria, as judged by the SLP.
- Unrelated health concerns that prevent children from participating, per parent report.
- Inability to meet toileting needs independently or separate from parent for a full day (as needed for camp), based on parent report.
Data sourced from ClinicalTrials.gov (NCT03903120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.