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
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.
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.
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 →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.
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CAS as a primary speech diagnosis, based on the following criteria:
Exclusion Criteria:
Immediate ASSIST, Simple condition
Behavioral: ASSIST
Immediate ASSIST, Complex condition
Behavioral: ASSIST
Delayed ASSIST, Simple condition
Behavioral: ASSIST
Delayed ASSIST, Complex condition
Behavioral: ASSIST
Immediate ASSIST, Word condition
Behavioral: ASSIST
Immediate ASSIST, Nonword condition
Behavioral: ASSIST
Delayed ASSIST, Word condition
Behavioral: ASSIST
Delayed ASSIST, Nonword condition
Behavioral: ASSIST
Immediate ASSIST, Massed condition
Behavioral: ASSIST
Delayed ASSIST, Massed condition
Behavioral: ASSIST
ASSIST, Distributed condition
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.
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)
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)
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)
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)
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)
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)
| Milestone | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate, Word | ASSIST Immediate, Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 0 | 0 | 0 |
| Completed | 4 | 5 | 4 | 4 | 5 | 5 | 5 | 5 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Declined treatment due to scheduling difficulties. | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate, Word | ASSIST Immediate, Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 4 | 5 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Declined treatment due to scheduling difficulties | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate, Word | ASSIST Immediate, Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 5 | 5 | 5 | 5 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 5 | 5 | 5 | 5 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate, Word | ASSIST Immediate, Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 6 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| percentage of accuracy (change score) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Immediate Massed | ASSIST Delayed Massed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1 (ASSIST vs No ASSIST) | -0.7 ± 3.8 | 10.6 ± 5.3 | -2.8 ± 6.6 | -1.4 ± 10.2 | 13.9 ± 14.8 | 14.7 ± 8.5 | 0.1 ± 7.0 | -4.9 ± 2.3 | — | — | — |
| Study 2: Simple vs Complex | -1.4 ± 7.6 | 21.1 ± 10.6 | 11.5 ± 8.1 | 6.5 ± 25.7 | — | — | — | — | — | — | — |
| Study 3: Word vs. Nonword | — | — | — | — | 30.2 ± 26.7 | 29.4 ± 16.9 | 11.6 ± 26.9 | 33.4 ± 22.4 | — | — | — |
| Study 4: Massed vs Distributed | — | — | — | — | — | — | — | — | -7.3 ± 4.6 | 2.6 ± 6.5 | 14.9 ± 14.3 |
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.
| Percent change in perceptual accuracy. | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Immediate Massed | ASSIST Delayed Massed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1: ASSIST vs No ASSIST | 0.3 ± 2.4 | 5.9 ± 3.8 | 1.0 ± 2.4 | 0.9 ± 3.2 | 4.9 ± 4.1 | 5.1 ± 4.9 | 3.9 ± 6.4 | 0.9 ± 2.3 | — | — | — |
| Study 2: Simple vs Complex | 0.6 ± 4.7 | 11.9 ± 7.6 | 4.5 ± 4.8 | 0.0 ± 9.1 | — | — | — | — | — | — | — |
| Study 3: Word vs Nonword | — | — | — | — | 9.8 ± 8.1 | 10.2 ± 9.8 | 2.2 ± 6.8 | 7.3 ± 8.8 | — | — | — |
| Study 4: Massed vs Distributed | — | — | — | — | — | — | — | — | -0.1 ± 4.0 | 3.2 ± 2.0 | 8.1 ± 5.9 |
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).
| change in units on a scale | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Immediate Massed | ASSIST Delayed Massed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1: ASSIST vs No ASSIST | 0.358 ± 0.665 | 0.183 ± 0.274 | 0.155 ± 0.215 | 0.250 ± 0.317 | 0.381 ± 0.595 | 0.464 ± 0.564 | -0.086 ± 0.216 | 0.143 ± 0.101 | — | — | — |
| Study 4: Massed vs Distributed | — | — | — | — | — | — | — | — | 0.000 ± 0.140 | 0.215 ± 0.106 | 0.200 ± 0.192 |
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).
| change in units on a scale | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Immediate Massed | ASSIST Delayed Massed | ASSIST Distributed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1: ASSIST vs No ASSIST | 0.807 ± 0.762 | 0.288 ± 0.394 | 0.2500 ± 0.5897 | 1.0120 ± 0.2761 | 0.394 ± 0.930 | 0.339 ± 0.420 | 0.094 ± 0.520 | 0.232 ± 0.575 | — | — | — |
| Study 4: Massed vs Distributed | — | — | — | — | — | — | — | — | -0.177 ± 0.478 | 0.500 ± 0.042 | 1.012 ± 0.276 |
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
Results for this outcome have not been posted.
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASSIST Immediate Simple | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| ASSIST Immediate Complex | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ASSIST Delayed Simple | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| ASSIST Delayed Complex | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| ASSIST Immediate Word | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ASSIST Immediate Nonword | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ASSIST Delayed Word | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ASSIST Delayed Nonword | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| ASSIST Immediate Massed | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| ASSIST Delayed Massed | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| ASSIST Distributed | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
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(years) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 6.67 ± 2.23 | 6.62 ± 2.11 | 5.46 ± 1.41 | 6.21 ± 0.91 | 5.60 ± 0.69 | 6.70 ± 1.44 | 6.20 ± 1.07 | 5.77 ± 1.45 | 5.83 ± 0.47 | 5.69 ± 1.14 | 6.73 ± 2.38 | 6.17 ± 1.5 |
| Sex: Female, Male(Participants) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 0 | 0 | 0 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 12 |
| Male | 1 | 5 | 4 | 4 | 3 | 4 | 3 | 4 | 2 | 2 | 5 | 37 |
| Ethnicity (NIH/OMB)(Participants) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 0 | 0 | 2 | 2 | 0 | 2 | 0 | 0 | 8 |
| Not Hispanic or Latino | 4 | 3 | 4 | 4 | 5 | 3 | 3 | 5 | 1 | 3 | 6 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| White | 4 | 4 | 2 | 2 | 3 | 4 | 4 | 5 | 2 | 2 | 5 | 37 |
| More than one race | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Speech Accuracy(percentage) | ASSIST Immediate Simple | ASSIST Immediate Complex | ASSIST Delayed Simple | ASSIST Delayed Complex | ASSIST Immediate Word | ASSIST Immediate Nonword | ASSIST Delayed Word | ASSIST Delayed Nonword | ASSIST Massed Immediate | ASSIST Massed Delayed | ASSIST Distributed | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1: ASSIST vs No ASSIST (Cycles 1 & 2) | 21.8 ± 9.8 | 21.7 ± 6.6 | 26.5 ± 9.2 | 23.6 ± 4.9 | 19.6 ± 11.4 | 19.4 ± 6.4 | 23.4 ± 17.2 | 14.0 ± 8.6 | — | — | — | 20.8 ± 3.4 |
| Study 2 (Complexity): Cycle 1 | 21.8 ± 9.8 | 21.7 ± 6.6 | 26.5 ± 9.2 | 23.6 ± 4.9 | — | — | — | — | — | — | — | 21.0 ± 3.5 |
| Study 3 (Lexicality): Cycle 2 | — | — | — | — | 19.6 ± 11.4 | 19.4 ± 6.4 | 23.4 ± 17.2 | 14.0 ± 8.6 | — | — | — | 19.1 ± 3.4 |
| Study 4 (Intensity): Cycle 3 | — | — | — | — | — | — | — | — | 24.1 ± 2.4 | 19.7 ± 3.4 | 17.9 ± 11.9 | 19.9 ± 2.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
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.
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.
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