Dose Frequency RCT on DTTC in Children With CAS

Study Overview
=================
Brief Summary
-----------------
Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the use of Dynamic Temporal and Tactile Cueing (DTTC; Strand, 2020). To date, a rigorous and systematic comparison of high and low dose frequency has not been undertaken for DTTC, resulting in a lack of evidence to guide decisions about the optimal treatment schedule for this intervention. The current study aims to fill this gap in knowledge by comparing treatment outcomes when dose frequency is varied. The goal of this clinical trial is to determine whether the number of treatment sessions per week has an effect on intervention outcomes in 60 children with CAS. The main question this research will address is whether whole word accuracy will differ between two groups of children undergoing DTTC treatment when one group of children receives treatment twice a week for 12 weeks and the other group receives treatment 4 times a week for 6 weeks. Community clinicians will administer all treatment sessions.

Detailed Description
-----------------
Sixty children with childhood apraxia of speech will be treated with DTTC treatment. A Phase III randomized controlled trial with parallel groups will be conducted to compare effects of low versus high dose frequency on DTTC treatment outcomes in children with CAS. Children with CAS between 2;5-7;11 years of age will be recruited to participate in this study. Treatment will be provided in the community setting by speech-language pathologists who have completed specialized training administering DTTC in a research reliable manner. True randomization with concealed allocation will be used to assign children to either the low or high dose frequency group. Treatment will be administered in 1-hour sessions either 4 times per week over a 6-week period (high dose) or 2 times per week over a 12-week period (low dose) for a total of 24 hours per child. To measure treatment gains, probe data will be collected before treatment, during treatment, and 1 day, 1 week, 4 weeks, and 12 weeks post-treatment. Probe data will consist of customized treated words and a standard set of untreated words to assess generalization of treatment gains. The primary outcome variable will be whole word accuracy, a measure of segmental, phonotactic, and suprasegmental accuracy. This will be the first randomized controlled trial (RCT) to evaluate dose frequency for DTTC treatment in children with CAS.

Official Title
-----------------
Dose Frequency Randomized Control Trial for Dynamic Temporal and Tactile Cueing (DTTC) Treatment for Childhood Apraxia of Speech

Conditions
-----------------
Childhood Apraxia of Speech

Intervention / Treatment
-----------------
* Behavioral: Dynamic Temporal and Tactile Cueing Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand & McCauley, 2019), 2;6-7;11 years of age at treatment commencement; English as the primary language; Exclusion Criteria: concomitant developmental disorders (including autism, global developmental delay, intellectual disability); diagnosis of severe or primary dysarthria as described below; palatal or structural orofacial anomalies as described below, uncorrected vision impairment hearing loss; receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age, Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds & Kamphaus, 2015), and no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed work is multisite Phase III parallel-group RCT that aims to investigate the outcomes of DTTC in children with CAS and determine whether dose frequency impacts response to treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Frequency<br>This group will receive treatment 4x/week for 6 weeks | Behavioral: Dynamic Temporal and Tactile Cueing Treatment<br>* DTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal & Gildersleeve-Neumann, 2011; Maas & Farinella, 2012; Maas et al., 2019; Strand & Debertine, 2000; Strand & Skinder, 1999), in which the clinician instructs the child to listen to me, watch me, and do what I do and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020).<br>* Other names: DTTC;|
| Active Comparator: Low Dose Frequency<br>This group will receive treatment 2x/week for 12 weeks | Behavioral: Dynamic Temporal and Tactile Cueing Treatment<br>* DTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal & Gildersleeve-Neumann, 2011; Maas & Farinella, 2012; Maas et al., 2019; Strand & Debertine, 2000; Strand & Skinder, 1999), in which the clinician instructs the child to listen to me, watch me, and do what I do and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020).<br>* Other names: DTTC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to whole word accuracy | A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe. | Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phoneme accuracy | Percentage of phonemes correct on the generalization probe | Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment) | 
| Speech Intelligibility | Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure | Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment) | 
| Functional communication | Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure | Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment, dose frequency, speech sound disorders, cumulative dosage, whole word accuracy, Dynamic Temporal and Tactile Cueing, DTTC, Childhood apraxia of speech