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Childhood Apraxia of SpeechPhase 1ASSISTNCT03903120

ASSIST: Treatment for Childhood Apraxia of Speech

A Phase 1 study testing ASSIST in people with Childhood Apraxia of Speech, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Apraxia of Speech
What is being tested?
ASSIST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
18 Apr 2019to 30 Nov 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Temple University

    Philadelphia, Pennsylvania, 19122

Other trials in United States

About this study

Official title: ASSIST: Child Apraxia Speech Treatment

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.

Read the detailed description

This research involves a hypothesis-driven series of Phase 1 studies using comparative group designs to investigate a new integral stimulation treatment program for children with CAS, called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment). The overall objective of this research is to test the initial efficacy of ASSIST and determine its optimal parameters.

Specific Aim 1: To test the initial efficacy of intensive ASSIST for children with CAS, by examining short-term improvements on the primary outcome measure of speech accuracy. Forty children (combined across two studies) will be randomly assigned to a treatment or a control group (who will receive the treatment). The central hypothesis is that ASSIST enhances speech motor skill, and predicts greater improvements after 2 weeks (16 hours) for the treatment group than for the control group (who have not yet received treatment). (Study 1)

Specific Aim 2: To determine the optimal parameters of ASSIST for children with CAS. In three studies, children (N=20 each) will be randomly assigned to condition, to address three critical treatment parameters:

Aim 2a: COMPLEXITY: simple vs. complex targets (Study 2). Simple targets may enhance motivation through greater success during treatment, but more complex targets may facilitate greater transfer.

Aim 2b: LEXICALITY: real word vs. nonword targets (Study 3). Real words may enhance motivation through functional relevance, but nonwords may facilitate transfer through a focus on underlying speech motor skills rather than existing lexical or speech motor representations.

Aim 2c: INTENSITY: massed vs. distributed ASSIST (Study 4). Massed practice may enhance learning through neuroplasticity principles, but motor learning principles predict greater learning for distributed practice.

Specific Aim 3: To determine changes on functional outcome measures following ASSIST treatment. In particular, for each of the three studies, the investigators will examine changes on the following outcome measures:

Aim 3a: Parent-rated measures of intelligibility and communicative participation.

Aim 3b: Objective measures of intelligibility based on transcriptions by unfamiliar listeners.

This research includes four small-scale group treatment studies (Studies 1-4), conducted over three recruitment cycles during the summer to minimize confounds from concurrent treatment provided at school. In all four treatment studies, 20 children will be randomly assigned to conditions and will receive 16 hours of ASSIST in two-week blocks (weeks 2-3 and/or 5-6). Data will be collected in weeks 1, 4, and 7 (T1, T2, and T3, respectively). Assessment will take place 2-8 weeks prior to T1 to allow time to develop individualized sets of potential treatment targets for each child. For each treatment study, the investigators will conduct a corresponding experiment with unfamiliar listeners (Studies 5-8) to evaluate potential impact of ASSIST on intelligibility. Studies 3 and 4 will be informed by, but are not contingent on, preceding studies. For example, if Study 2 shows an advantage for simple targets, then Study 3 will compare simple words vs. simple nonwords. Thus, each study independently contributes to the overall objective of this proposal and addresses an independent aim.

Children will attend a summer camp with 19 other children. Camp days (4 days per week during treatment block 1 [weeks 2-3] and treatment block 2 [weeks 5-6]) are 8:00 am to 3:00 pm and involve group activities and individual treatment sessions. All children participate in child-appropriate group activities in both treatment blocks (e.g., arts and crafts projects, games). Group activities are not treatment and have no focus on communication, but serve as the control condition. Treatment follows the pull-out model in which children attend individual treatment sessions in a separate room and then return to the group room. Treatment will be delivered by SLP graduate students under supervision of certified, licensed, and experienced SLPs.

Treatment involves 32 individual sessions of 30-minutes (16 hours total) in which the child works with an SLP graduate student clinician to work on individualized speech goals. Children in intensive ASSIST conditions (all children in Studies 1-3, and Massed ASSIST groups in Study 4) will receive four 30-minute sessions per day (2 in the morning, 2 in the afternoon) separated by at least one hour to minimize fatigue, in either the first treatment block (camp weeks 2-3) or the second treatment block (camp weeks 5-6). Children in the Distributed ASSIST condition (Study 4) will receive two 30-minutes sessions per day (1 in the morning, 1 in the afternoon) separated by at least one hour to minimize fatigue, in both treatment blocks (camp weeks 2-3 and 5-6).

Treatment words or phrases will be tailored to each child based on pre-treatment testing and personal relevance, as well as study aim. From each child's list of potential targets, two sets will be created and matched on relevant variables except for those under study. One set will be treated; the other set will serve to measure generalization (randomly assigned). Each target will be practiced in several frames (e.g., more _ , I want _ , _ is yummy) to bolster communicative relevance, enable variable practice, incorporate prosody, and engage language.

Each 30-minute session targets several items (active set) from the treatment set developed for each child; new items are introduced as previous items are mastered and moved to maintenance practice. ASSIST uses step-up and step-down criteria for adaptive practice and pre-practice and practice components. Each session starts with pre-practice to ensure motivation, establish a reference of correctness and ability to identify a correct response, and establish ability to produce an accurate response. During pre-practice, the clinician elicits targets via integral stimulation on the first attempt, provides feedback and elicits additional attempts using cues and supports as needed. The clinician also solicits the child's self-evaluation (e.g., "Did that sound right?") and provides feedback on this self-evaluation. Criteria to begin practice are either ≥1 accurate response per target and correctly identifying ≥1 accurate response, or 15 minutes have elapsed (to ensure that sessions include at least 10 minutes of practice). During practice, the clinician aims to elicit as many attempts as possible. Treatment will follow a structured protocol with event sequences called teaching episodes. A teaching episode involves an initial target elicitation by the clinician, followed by feedback and/or a cue and another attempt by the child. Thus, each teaching episode involves at least two attempts by the child. Practice occurs in practice runs, which are bursts of practice separated by 1-minute breaks to minimize risk of fatigue. A practice run will continue for 4 minutes or until each target in the child's active set has cycled through 5 teaching episodes. The last practice run of a session includes all previously targeted items (active set + maintenance items). Conditions are systematically adapted to facilitate learning.

Adult listeners will transcribe recordings of speech samples produced by children with CAS. Listeners will hear speech samples (randomized with respect to time of recording) and type what the child said. They will be able to control the volume to ensure a comfortable loudness level. They will type their responses to enhance data quality (legibility). These procedures will take up to 2 hours, which may be completed in a single 2-hour session or two 1-hour sessions.

Being tested
ASSIST
Medical subject headings
Apraxias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASSISTBehavioural

    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.

Study groups in NCT03903120
Study groupRoleWhat they receive
ASSIST Immediate SimpleExperimentalImmediate ASSIST, Simple condition
Receives: Behavioral: ASSIST
ASSIST Immediate ComplexExperimentalImmediate ASSIST, Complex condition
Receives: Behavioral: ASSIST
ASSIST Delayed SimpleExperimentalDelayed ASSIST, Simple condition
Receives: Behavioral: ASSIST
ASSIST Delayed ComplexExperimentalDelayed ASSIST, Complex condition
Receives: Behavioral: ASSIST
ASSIST Immediate WordExperimentalImmediate ASSIST, Word condition
Receives: Behavioral: ASSIST
ASSIST Immediate NonwordExperimentalImmediate ASSIST, Nonword condition
Receives: Behavioral: ASSIST
ASSIST Delayed WordExperimentalDelayed ASSIST, Word condition
Receives: Behavioral: ASSIST
ASSIST Delayed NonwordExperimentalDelayed ASSIST, Nonword condition
Receives: Behavioral: ASSIST
ASSIST Immediate MassedExperimentalImmediate ASSIST, Massed condition
Receives: Behavioral: ASSIST
ASSIST Delayed MassedExperimentalDelayed ASSIST, Massed condition
Receives: Behavioral: ASSIST
ASSIST DistributedExperimentalASSIST, Distributed condition
Receives: Behavioral: ASSIST

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Speech Accuracy of Untreated Generalization Items

    Change in Perceptual accuracy of untreated 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.

    Measured: 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)

  2. ICS Average Score (Intelligibility-in-Context Scale)

    Change in Parent rating of intelligibility in context using the Intelligibility in Context Scale. 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. Change scores are calculated as defined by ClinicalTrials.gov.

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

    Measured: 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)

  3. FOCUS-34 Total Score

    Change in Parent rating of communicative participation using the Focus on Outcomes of Communication Under Six. 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. Change scores are calculated as defined by ClinicalTrials.gov.

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

    Measured: 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)

  4. TOCS+ Intelligibility (Percentage Words Correctly Understood) Change Score

    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). Change scores are calculated as defined by ClinicalTrials.gov

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start18 Apr 2019
  3. Primary completion31 Aug 2024
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903120
Sponsor's protocol ID
NCT03903120
Other IDs
R01DC017768
Acronym
ASSIST
Status last verified
Apr 2026
First submitted
29 Mar 2019
Last updated
22 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASSIST in people with Childhood Apraxia of Speech, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech Accuracy of Treated Items (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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