Phase 1
N=39
ASSIST: Treatment for Childhood Apraxia of Speech
Childhood Apraxia of Speech
Bottom Line
View on ClinicalTrials.gov: NCT03903120 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Speech Accuracy of Treated Items — -0.7; 10.6; -2.8; -1.4 percentage of accuracy (change score) — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ASSIST (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Aug 2024
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 |
— | — |
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.
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.