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CompletedNCT03903120ASSISTUpdated May 22, 2026Results posted

ASSIST: Treatment for Childhood Apraxia of Speech

A Phase 1 interventional study of ASSIST in Childhood Apraxia of Speech, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 4 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Temple University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Childhood Apraxia of Speech

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03

In context

Apraxias

65 studies on the registry are indexed under Apraxias; 21 are open to participants now.

This study's enrollment of 51 is above the median of 32 across 50 interventional studies indexed under Apraxias.

Browse Apraxias studies →

Lead sponsor

Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    ASSIST Immediate Simple

    Immediate ASSIST, Simple condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Immediate Complex

    Immediate ASSIST, Complex condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Delayed Simple

    Delayed ASSIST, Simple condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Delayed Complex

    Delayed ASSIST, Complex condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Immediate Word

    Immediate ASSIST, Word condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Immediate Nonword

    Immediate ASSIST, Nonword condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Delayed Word

    Delayed ASSIST, Word condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Delayed Nonword

    Delayed ASSIST, Nonword condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Immediate Massed

    Immediate ASSIST, Massed condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Delayed Massed

    Delayed ASSIST, Massed condition

    Behavioral: ASSIST

  • Experimental
    ASSIST Distributed

    ASSIST, Distributed condition

    Behavioral: ASSIST

Interventions

  • BehavioralASSIST

    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.

06

What researchers measure

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.

    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)

Secondary outcomes

  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.

    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)

  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).

    Time frame: 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).

    Time frame: 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

    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)

07

Results

Posted May 22, 2026

Participant flow

Recruitment period: April 2019 - June 2022 Total N=51 (Study 1, Recruitment Cycle 1: April-June 2019, n=19) (Study 1. Recruitment Cycle 2: February-June 2022; n=20) (Study 3: February-June 2021; n=12)

Study 1: ASSIST vs. No ASSIST
Participant flow — Study 1: ASSIST vs. No ASSIST
MilestoneASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate, WordASSIST Immediate, NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST Distributed
Started55455555000
Completed45445555000
Not completed10010000000
Withdrew: Declined treatment due to scheduling difficulties.10010000000
Study 2: Simple vs Complex
Participant flow — Study 2: Simple vs Complex
MilestoneASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate, WordASSIST Immediate, NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST Distributed
Started55450000000
Completed45440000000
Not completed10010000000
Withdrew: Declined treatment due to scheduling difficulties10010000000
Study 3: Word vs Nonword
Participant flow — Study 3: Word vs Nonword
MilestoneASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate, WordASSIST Immediate, NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST Distributed
Started00005555000
Completed00005555000
Not completed00000000000
Study 4: Massed vs Distributed
Participant flow — Study 4: Massed vs Distributed
MilestoneASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate, WordASSIST Immediate, NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST Distributed
Started00000000336
Completed00000000335
Not completed00000000001
Withdrew: Lost to follow-up00000000001

Outcome measures

PrimarySpeech 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.

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)
Reported as:
Mean · percentage of accuracy (change score)
Speech Accuracy of Treated Items
percentage of accuracy (change score)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Immediate MassedASSIST Delayed MassedASSIST Distributed
Study 1 (ASSIST vs No ASSIST)-0.7 ± 3.810.6 ± 5.3-2.8 ± 6.6-1.4 ± 10.213.9 ± 14.814.7 ± 8.50.1 ± 7.0-4.9 ± 2.3———
Study 2: Simple vs Complex-1.4 ± 7.621.1 ± 10.611.5 ± 8.16.5 ± 25.7———————
Study 3: Word vs. Nonword————30.2 ± 26.729.4 ± 16.911.6 ± 26.933.4 ± 22.4———
Study 4: Massed vs Distributed————————-7.3 ± 4.62.6 ± 6.514.9 ± 14.3
Statistical analysis
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex vs ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.0001 (No adjustments to p-value.) · T-value: 4.3
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex · t-test, 2 sided · p = 0.2242 · T-value: 1.27No adjustments made.
  • ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.3271 · T-value: 1.01No adjustments made.
  • ASSIST Immediate Massed vs ASSIST Delayed Massed vs ASSIST Distributed · t-test, 2 sided · p = 0.0371 (No adjustments made.) · T-value: 2.44
SecondarySpeech 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.

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)
Reported as:
Mean · Percent change in perceptual accuracy.
Speech Accuracy of Untreated Generalization Items
Percent change in perceptual accuracy.ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Immediate MassedASSIST Delayed MassedASSIST Distributed
Study 1: ASSIST vs No ASSIST0.3 ± 2.45.9 ± 3.81.0 ± 2.40.9 ± 3.24.9 ± 4.15.1 ± 4.93.9 ± 6.40.9 ± 2.3———
Study 2: Simple vs Complex0.6 ± 4.711.9 ± 7.64.5 ± 4.80.0 ± 9.1———————
Study 3: Word vs Nonword————9.8 ± 8.110.2 ± 9.82.2 ± 6.87.3 ± 8.8———
Study 4: Massed vs Distributed————————-0.1 ± 4.03.2 ± 2.08.1 ± 5.9
Statistical analysis
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex vs ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.0697 (No adjustments to p-value.) · T-value: 1.87
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex · t-test, 2 sided · p = 0.3145 (No adjustments.) · T-value: 1.04
  • ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.4717 · T-value: 0.74No adjustments.
  • ASSIST Immediate Massed vs ASSIST Delayed Massed vs ASSIST Distributed · t-test, 2 sided · p = 0.0563 · T-value: 2.57
SecondaryICS 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).

Time frame:
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)
Reported as:
Mean · change in units on a scale
ICS Average Score (Intelligibility-in-Context Scale)
change in units on a scaleASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Immediate MassedASSIST Delayed MassedASSIST Distributed
Study 1: ASSIST vs No ASSIST0.358 ± 0.6650.183 ± 0.2740.155 ± 0.2150.250 ± 0.3170.381 ± 0.5950.464 ± 0.564-0.086 ± 0.2160.143 ± 0.101———
Study 4: Massed vs Distributed————————0.000 ± 0.1400.215 ± 0.1060.200 ± 0.192
Statistical analysis
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex vs ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.0806 · T-value: -1.80
  • ASSIST Immediate Massed vs ASSIST Delayed Massed vs ASSIST Distributed · ANOVA · p = 0.9336 · F-value: 0.01
SecondaryFOCUS-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).

Time frame:
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)
Reported as:
Mean · change in units on a scale
FOCUS-34 Total Score
change in units on a scaleASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Immediate MassedASSIST Delayed MassedASSIST Distributed
Study 1: ASSIST vs No ASSIST0.807 ± 0.7620.288 ± 0.3940.2500 ± 0.58971.0120 ± 0.27610.394 ± 0.9300.339 ± 0.4200.094 ± 0.5200.232 ± 0.575———
Study 4: Massed vs Distributed————————-0.177 ± 0.4780.500 ± 0.0421.012 ± 0.276
Statistical analysis
  • ASSIST Immediate Simple vs ASSIST Immediate Complex vs ASSIST Delayed Simple vs ASSIST Delayed Complex vs ASSIST Immediate Word vs ASSIST Immediate Nonword vs ASSIST Delayed Word vs ASSIST Delayed Nonword · t-test, 2 sided · p = 0.3012 · T-value: -1.05
  • ASSIST Immediate Massed vs ASSIST Delayed Massed vs ASSIST Distributed · ANOVA · p = 0.0269 · F-value: 6.97
SecondaryTOCS+ 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

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)

Results for this outcome have not been posted.

Adverse events

Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ASSIST Immediate Simple0/4 (0%)0/4 (0%)0/4 (0%)
ASSIST Immediate Complex0/5 (0%)0/5 (0%)0/5 (0%)
ASSIST Delayed Simple0/4 (0%)0/4 (0%)0/4 (0%)
ASSIST Delayed Complex0/4 (0%)0/4 (0%)0/4 (0%)
ASSIST Immediate Word0/5 (0%)0/5 (0%)0/5 (0%)
ASSIST Immediate Nonword0/5 (0%)0/5 (0%)0/5 (0%)
ASSIST Delayed Word0/5 (0%)0/5 (0%)0/5 (0%)
ASSIST Delayed Nonword0/5 (0%)0/5 (0%)0/5 (0%)
ASSIST Immediate Massed0/3 (0%)0/3 (0%)0/3 (0%)
ASSIST Delayed Massed0/3 (0%)0/3 (0%)0/3 (0%)
ASSIST Distributed0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Study 1 (comparing ASSIST vs. No ASSIST \[Delayed Control\]) is based on Immediate and Delayed groups across Study 2 (Simple vs Complex) and Study 3 (Word vs Nonword).

Age, Continuous
Age, Continuous(years)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST DistributedTotal
Mean6.67 ± 2.236.62 ± 2.115.46 ± 1.416.21 ± 0.915.60 ± 0.696.70 ± 1.446.20 ± 1.075.77 ± 1.455.83 ± 0.475.69 ± 1.146.73 ± 2.386.17 ± 1.5
Sex: Female, Male
Sex: Female, Male(Participants)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST DistributedTotal
Female3000212111112
Male1544343422537
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST DistributedTotal
Hispanic or Latino020002202008
Not Hispanic or Latino4344533513641
Unknown or Not Reported000000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST DistributedTotal
American Indian or Alaska Native000000000000
Asian000000000000
Native Hawaiian or Other Pacific Islander000000000000
Black or African American010220000005
White4422344522537
More than one race002001101016
Unknown or Not Reported000000000101
Speech Accuracy
Speech Accuracy(percentage)ASSIST Immediate SimpleASSIST Immediate ComplexASSIST Delayed SimpleASSIST Delayed ComplexASSIST Immediate WordASSIST Immediate NonwordASSIST Delayed WordASSIST Delayed NonwordASSIST Massed ImmediateASSIST Massed DelayedASSIST DistributedTotal
Study 1: ASSIST vs No ASSIST (Cycles 1 & 2)21.8 ± 9.821.7 ± 6.626.5 ± 9.223.6 ± 4.919.6 ± 11.419.4 ± 6.423.4 ± 17.214.0 ± 8.6———20.8 ± 3.4
Study 2 (Complexity): Cycle 121.8 ± 9.821.7 ± 6.626.5 ± 9.223.6 ± 4.9———————21.0 ± 3.5
Study 3 (Lexicality): Cycle 2————19.6 ± 11.419.4 ± 6.423.4 ± 17.214.0 ± 8.6———19.1 ± 3.4
Study 4 (Intensity): Cycle 3————————24.1 ± 2.419.7 ± 3.417.9 ± 11.919.9 ± 2.8
08

Study locations

1 site
  • Temple University
    Philadelphia, Pennsylvania 19122, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Aug 2024, 64 months.

Results were first posted in May 2026, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2019
First posted
Apr 4, 2019
StartActual
Apr 18, 2019
Primary completionActual
Aug 31, 2024
CompletionActual
Nov 30, 2025
Results first posted
May 22, 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03903120
Lead sponsor
Temple University
Responsible party
Sponsor
First posted
Apr 4, 2019
Start date
Apr 18, 2019
Primary completion
Aug 31, 2024
Completion
Nov 30, 2025
Results posted
May 22, 2026
Last update
May 22, 2026

Study contacts

Edwin Maas, Ph.D.
principal investigator · Temple University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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