ASSIST: Treatment for Childhood Apraxia of Speech (NCT03903120) | Clinical Trial Compass
CompletedPhase 1
ASSIST: Treatment for Childhood Apraxia of Speech
United States51 participantsStarted 2019-04-18
Plain-language 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.
Who can participate
Age range
4 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<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).
. CAS as a primary speech diagnosis, based on the following criteria:
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Speech Accuracy of Treated Items
Timeframe: Study 1: T2 (after a 2-week period, Weeks 2-3) Study 2: T2 for Immediate groups, T3 for Delayed groups Study 3: T2 for Immediate groups, T3 for Delayed groups Study 4: T3 (after a 4-week period, Weeks 2-3 and 5-6)
. 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).
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.