ASSIST: Treatment for Childhood Apraxia of Speech

NCT03903120 | Active Not Recruiting Phase 1

• 1 other identifier: R01DC017768
• Study Type: interventional
• Target: 420
• 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 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

Outcome Measures

Primary Outcomes (1)

• Speech Accuracy of Treated Items

  Perceptual accuracy of treated items, judged by blinded listeners. Will be used to address Aim 1 (initial efficacy of ASSIST) and Aims 2 (optimal parameters of ASSIST).

  1 week post treatment

Secondary Outcomes (4)

• Speech Accuracy of Untreated Generalization Items

  1 week post treatment

• ICS Average Score

  1 week post treatment

• FOCUS-34 Total Score

  1 week post treatment

• TOCS+ Intelligibility (percentage words correctly understood)

  1 week post treatment

Study Arms (4)

ASSIST

EXPERIMENTAL

Study 1 and 2

Behavioral: ASSIST

Delayed Control

NO INTERVENTION

Study 1 and 2

Massed ASSIST

EXPERIMENTAL

Study 3

Behavioral: ASSIST

Distributed ASSIST

EXPERIMENTAL

Study 3

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; Distributed ASSIST; Massed ASSIST

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

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

Study Officials

• Edwin Maas, Ph.D.

  Temple University

  PRINCIPAL INVESTIGATOR

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 and 2). Parallel groups with distributed or massed intervention (Study 3)

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: March 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

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)