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ASSIST: Treatment for Childhood Apraxia of Speech (ASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903120
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Childhood Apraxia of Speech Behavioral: ASSIST Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel groups with delayed treatment control group (Study 1 and 2). Parallel groups with distributed or massed intervention (Study 3)
Masking: Single (Outcomes Assessor)
Masking Description: Data Collector also masked.
Primary Purpose: Treatment
Official Title: ASSIST: Child Apraxia Speech Treatment
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Experimental: ASSIST
Study 1 and 2
Behavioral: ASSIST
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.

No Intervention: Delayed Control
Study 1 and 2
Experimental: Massed ASSIST
Study 3
Behavioral: ASSIST
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.

Experimental: Distributed ASSIST
Study 3
Behavioral: ASSIST
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.




Primary Outcome Measures :
  1. Speech Accuracy of Treated Items [ Time Frame: 1 week post treatment ]
    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).


Secondary Outcome Measures :
  1. Speech Accuracy of Untreated Generalization Items [ Time Frame: 1 week post treatment ]
    Perceptual accuracy of untreated items, judged by blinded listeners. Will be used to address Aim 1 (initial efficacy of ASSIST) and Aims 2 (optimal parameters of ASSIST).

  2. ICS Average Score [ Time Frame: 1 week post treatment ]

    Parent rating of intelligibility in context using the Intelligibility in Context Scale (McLeod et al., 2012, 2015). This will be used to address Aim 3 (functional outcomes of ASSIST).

    The ICS has 7 items which are rated on a scale from 1 to 5. The Average Score is the mean of the ratings across the 7 items (possible score range = 1 to 5). Higher scores reflect better performance.

    The ICS captures the ease with which children are understood in their lives by different interaction partners (e.g., teachers, family members, strangers).


  3. FOCUS-34 Total Score [ Time Frame: 1 week post treatment ]

    Parent rating of communicative participation using the Focus on Outcomes of Communication Under Six (Thomas-Stonell et al., 2015). This will be used to address Aim 3 (functional outcomes of ASSIST).

    The FOCUS-34 has 34 items which are rated on a scale from 1 to 7. The Total Score is the sum of the ratings across the 34 items (possible score range = 34 to 238). Higher scores reflect better performance.

    The FOCUS-34 captures the degree of a child's communicative participation (e.g., my child uses words to ask for things).


  4. TOCS+ Intelligibility (percentage words correctly understood) [ Time Frame: 1 week post treatment ]
    Percentage of words correctly understood from the audio recording by blinded unfamiliar listeners, based on the Test of Children's Speech (Hodge et al., 2009). This will be used to address Aim 3 (functional outcomes of ASSIST).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903120


Contacts
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Contact: Edwin Maas, Ph.D. 215-204-1148 emaas@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Edwin Maas, PhD    215-204-1148    emaas@temple.edu   
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Edwin Maas, Ph.D. Temple University
  Study Documents (Full-Text)

Documents provided by Temple University:
Informed Consent Form  [PDF] March 26, 2019

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03903120    
Other Study ID Numbers: R01DC017768 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data spreadsheets containing finalized outcome measures for each child (e.g., speech accuracy data and intelligibility data) will be made available upon request to the PI to interested researchers, speech-language pathologists, and members of the general public. These data will be de-identified.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apraxias
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases