Role of Omega-DEK in Childhood Apraxia of Speech

Percent of Participants Retained in Study

Feasibility of the intervention is assessed with the percentage of enrolled participants who complete the 20 week study. Successful retention is defined as \>85% of enrolled participants completing the study.

Percent of Expanded Cohort Recruited

Feasibility of conducting a 12-month, open-label trial is measured by successful recruitment, which is defined as \<20% refusal of eligible children.

Percent of Expanded Cohort Retained

Feasibility of conducting a 12-month, open-label trial is measured by successful retention, which is defined as \>85% of study participants completing the study.

Percent of Expanded Cohort Complying with Treatment Regimen

Feasibility of conducting a 12-month, open-label trial is measured by successful compliance, which is defined as \>75% of participants with compliance with the treatment regimen.

Percent of Participants With Complete Outcome Data

Feasibility of the intervention is assessed with the percentage of participants who complete all surveys and study visits. Successful collection of outcome data is defined as \>90% of participants completing study surveys and visits.

Change in Dynamic Evaluation of Motor Speech Skill (DEMSS) Score

The Dynamic Evaluation of Motor Speech Skill (DEMSS) is a validated tool specifically designed to identify the level of breakdown in a child's ability to speak so that treatment can be established, and improvement tracked. The DEMSS is comprised of 9 subtests with a total of 66 utterances which are associated with 171 items. Four subscores for overall articulatory accuracy of the word, vowel accuracy, prosodic accuracy, and consistency, are calculated. An overall score is calculated and ranges from 0 to 426, where lower scores suggest that CAS is present. Within a clinical setting, scores between 0 and 323 indicate CAS, scores between 323 and 373 indicate mild evidence of mild CAS, and scores of 373 to 426 indicate little or no evidence of CAS. Baseline scores are compared to scores at Week 12, for analysis of the open-label portion of the study, while Week 12 and Week 20 scores are compared for analysis of the randomized discontinuation portion of the study.

Mean Length of Utterances (MLU)

Mean length of utterance (MLU) is an assessment of expressive language measures the average number of morphemes per utterance. Morphemes are smallest language elements that make up linguistic expression. A spontaneous speech sample will be obtained and MLU is calculated as the number of morphemes in each utterance divided by the total number of utterances.

Clinical Global Impression for Improvement Scale (CGI-I) Score

The CGI-I is a 7-point scale designed to measure overall improvement from baseline. The CGI-I is rated by an independent evaluator who is blind to treatment assignment during the randomized discontinuation phase. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). Positive response to treatment (an improvement from baseline) is defined by a rating of Much Improved or Very Much Improved. Scores of 3 (minimally improved), 4 (no change) and 5 (minimally worse) indicate no change. Scores of 6 or 7 are considered as a worsening of symptoms from baseline (a negative response).