Trial Outcomes & Findings for ASSIST: Treatment for Childhood Apraxia of Speech (NCT NCT03903120)

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)

Assessment prior to assignment to arm. The ASSIST vs. No ASSIST (Delayed Control) comparison is based on 2 recruitment cycles (each with an immediate and a delayed control group). Arms are combined across both recruitment cycles.

Study 1 is based on data from two Recruitment Cycles (each with a delayed control group cross-over design, Immediate vs Delayed ASSIST). Participants in Study 1 also contributed data to another study: Participants from Recruitment Cycle 1 also contribute to Study 2, and participants from Recruitment Cycle 2 also contribut to Study 3. Participants in Massed Arms/Groups only participated in Study 4.

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.

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.

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 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).

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