ASSIST: Treatment for Childhood Apraxia of Speech

NCT03903120 | Completed Phase 1 Results

• 2 other identifiers: NCT03903120R01DC017768
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Apraxia of Speech

Outcome Measures

Primary Outcomes (1)

• Speech Accuracy of Treated Items

  Change in Perceptual accuracy of treated items (in percent), judged by 3 blinded listeners and averaged across the 3 listeners to obtain a single percent accuracy score. Listeners score each item as a 2 \[correct\], 1 \[minor error\], or 0 \[major error or multiple errors\]; scores are averaged across listeners and divided by 2 and multiplied by 100 to create a percentage. Change scores are calculated as defined by ClinicalTrials.gov.

  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)

Secondary Outcomes (4)

• Speech Accuracy of Untreated Generalization Items

  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)

• ICS Average Score (Intelligibility-in-Context Scale)

  Study 1: T2 (after a 2-week period, Weeks 2-3) Study 4: T3 (after a 4-week period, Weeks 2-3 and 5-6)

• FOCUS-34 Total Score

  Study 1: T2 (after a 2-week period, Weeks 2-3) Study 4: T3 (after a 4-week period, Weeks 2-3 and 5-6)

• TOCS+ Intelligibility (Percentage Words Correctly Understood) Change Score

  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)

Study Arms (11)

ASSIST Immediate Simple

EXPERIMENTAL

Immediate ASSIST, Simple condition

Behavioral: ASSIST

ASSIST Immediate Complex

EXPERIMENTAL

Immediate ASSIST, Complex condition

Behavioral: ASSIST

ASSIST Delayed Simple

EXPERIMENTAL

Delayed ASSIST, Simple condition

Behavioral: ASSIST

ASSIST Delayed Complex

EXPERIMENTAL

Delayed ASSIST, Complex condition

Behavioral: ASSIST

ASSIST Immediate Word

EXPERIMENTAL

Immediate ASSIST, Word condition

Behavioral: ASSIST

ASSIST Immediate Nonword

EXPERIMENTAL

Immediate ASSIST, Nonword condition

Behavioral: ASSIST

ASSIST Delayed Word

EXPERIMENTAL

Delayed ASSIST, Word condition

Behavioral: ASSIST

ASSIST Delayed Nonword

EXPERIMENTAL

Delayed ASSIST, Nonword condition

Behavioral: ASSIST

ASSIST Immediate Massed

EXPERIMENTAL

Immediate ASSIST, Massed condition

Behavioral: ASSIST

ASSIST Delayed Massed

EXPERIMENTAL

Delayed ASSIST, Massed condition

Behavioral: ASSIST

ASSIST Distributed

EXPERIMENTAL

ASSIST, Distributed condition

Behavioral: ASSIST

Interventions

ASSIST BEHAVIORAL

Integral stimulation based treatment ("watch me, listen to me, say what I say") for CAS that is based on principles of motor learning and neuroplasticity and includes a systematic approach to adaptive practice. Treatment includes a focus on prosody, use of visual, tactile, auditory cues, slowing speech rate, and large amounts of practice.

ASSIST Delayed Complex; ASSIST Delayed Massed; ASSIST Delayed Nonword; ASSIST Delayed Simple; ASSIST Delayed Word; ASSIST Distributed; ASSIST Immediate Complex; ASSIST Immediate Massed; ASSIST Immediate Nonword; ASSIST Immediate Simple; ASSIST Immediate Word

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Apraxias

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Edwin Maas
• Organization: Temple University

emaas@temple.edu

215-204-1148

Study Officials

• Edwin Maas, Ph.D.

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Collector also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel groups with delayed treatment control group (Study 1). Parallel groups design (Study 2 and 3). Parallel groups with distributed or massed intervention (Study 4)

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: April 18, 2019
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 1 year after the primary publication based on those data has been accepted for publication.
• Access Criteria: Data access will only be provided upon submitting a completed and signed data sharing agreement to the PI.

Locations

US (1)