ASSIST: Treatment for Childhood Apraxia of Speech
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 three small randomized group design studies, children (N=20 per study) receive 16 hours of individual ASSIST. The three studies systematically investigate treatment intensity (2 vs. 4 weeks) and two critical aspects of target selection: complexity (simple vs. complex target) and lexicality (words vs. nonwords). Each study also systematically examines the effect of treatment on functional outcome measures, including parent ratings of intelligibility and communicative participation, and objective intelligibility measures obtained from unfamiliar listeners.
Conditions:
🦠 Childhood Apraxia of Speech
🗓️ Study Start (Actual) 18 April 2019
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 420
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 4 Years to 9 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 March 2019
  • First Submitted that Met QC Criteria 2 April 2019
  • First Posted 4 April 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 April 2024
  • Last Update Posted 2 May 2024
  • Last Verified April 2024