RecruitingACTRN12621000666820

A Randomized Controlled Trial comparing Dynamic Temporal and Tactile Cueing with usual care for Childhood Apraxia of Speech


Sponsor

The University of Sydney

Enrollment

120 participants

Start Date

Jun 1, 2022

Study Type

Interventional

Conditions

Summary

This research will explore the efficacy of Dynamic Temporal and Tactile Cuing (DTTC or Dynamic Therapy) a well-established treatment that has only been tested in small scale studies. The study will compare Dynamic Therapy with usual care which is the speech therapy that children routinely receive in the community. We will also estimate the cost of therapy and make recommendations for which treatment option is most cost-effective. The study is a two-arm randomised controlled trial. This is the first such study for children with apraxia who are under 8 years old.


Eligibility

Sex: Both males and femalesMin Age: 36 MonthssMax Age: 8 Yearss

Plain Language Summary

Simplified for easier understanding

Childhood apraxia of speech (CAS) is a motor speech disorder where a child has difficulty planning and coordinating the movements needed to produce clear speech. It is not caused by muscle weakness but rather by challenges in programming the precise sequences of movement. Dynamic Temporal and Tactile Cueing (DTTC) is a well-regarded therapy approach that uses carefully timed physical and verbal cues to help children learn these movement patterns. Despite promising results in small studies, it has never been tested in a proper randomised controlled trial. This study compares DTTC with the usual speech therapy that children receive in the community, in children aged 3 to nearly 8 years old with moderate-to-severe CAS. The study also evaluates the cost-effectiveness of each approach. Your child may be eligible if they have been formally diagnosed with apraxia of speech, are between 3 years and 7 years 11 months old, have a moderate to severe speech impairment, have normal hearing and vision, and use English as their primary language. Children with a concurrent diagnosis of autism, global developmental delay, or a structural issue such as cleft palate are not eligible.

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Interventions

INTERVENTION: Dynamic Therapy (Dynamic Temporal and Tactile Cueing or DTTC) Dynamic Therapy is based on established integral stimulation techniques for speech motor learning (“look at me, listen to

INTERVENTION: Dynamic Therapy (Dynamic Temporal and Tactile Cueing or DTTC) Dynamic Therapy is based on established integral stimulation techniques for speech motor learning (“look at me, listen to me, say what I say”) and involves intensive drills on a core set of meaningful but relatively simple words containing sounds that the child already can produce (e.g., “Hi daddy”) and those sounds that are emerging. Treatment words which are highly salient and frequently used are chosen with the child and their family. In Dynamic Therapy, the clinician systematically works toward independent (non-imitated) production by fading cues in a hierarchy. Speaking rate is reduced, and the time between clinician model and child’s response is varied based on the child’s performance; tactile cues are provided as needed to demonstrate articulatory configurations. Rapid reinforcers are used to maximize the number of practice trials per session. Dynamic Therapy is flexible in providing children with severe apraxia the cues they need to acquire accurate words and phrases. It incorporates principles of motor learning, which refer to practice conditions that are thought to enhance learning (e.g., reducing feedback as the child improves; practicing the same target multiple times in a row before practicing targets in random order) (Maas et al., 2008). MATERIALS: Materials will include a laptop with an external microphone plus accessories, and videorecorder plus accessories (tripod, memory cards) for data collection and recording treatment sessions. Additional supplies will include standardized speech pathology behavioral tests and score forms, recruitment materials, data sheets, printing, participant costs, open access publishing, and office supplies. WHO WILL DELIVER THE TREATMENT: Speech Pathologists who have been trained by the research team in Dynamic Therapy will provide treatment to participants. An operationalized version of DTTC (Dynamic Therapy) co-developed with Dr. Edythe Strand will be used to train clinicians across the different clinical sites, allowing them to deliver the same therapy and allowing us to measure fidelity. This operationalized version will include a pre-practice phase to address precursors to learning. CLINICIAN TRAINING: Treating clinicians will complete training in Dynamic Therapy. This will include: - Reading the tutorial article about Dynamic Temporal and Tactile Cueing (DTTC) (https://doi.org/10.1044/2019_ajslp-19-0005) - View online videos and demonstrations instructing clinicians in the procedures relevant to Dynamic Therapy (duration: 2-4 hours) - Read and implement the Dynamic Therapy treatment manual. A treatment manual has been designed for this study. Once all participants have completed their Dynamic Therapy treatment, the manual will be publicly available on the Dynamic Therapy website. - Where possible, clinicians will be encouraged to treat a non-RCT child or children in their regular clinical practice with DTTC before treating research participants. - Receive feedback on their treatment fidelity from the Fidelity Manager, Megan Leece. - Receive a one-hour video coaching session from a Dynamic Therapy expert, AI Professor Edythe Strand. An online community of practice will also be established. This community of practice will include a chat function for discussion between the clinicians moderated by one of the CIs or the Fidelity Manager, a questions portal for direct access to our group of Dynamic Therapy experts (CIs and AIs) and a resources portal where the clinicians will be able to re-visit training videos, the training manual, relevant research articles and ask questions. MODE OF DELIVERY: Participants will receive treatment in-person, face-to-face. LOCATION: In Australia and the United States, children will receive therapy at one of the identified clinical sites, or, if indicated by the participant's parent/carer, in community facilities (e.g. Libraries) or in the participant's home. TREATMENT DOSAGE: Children in this study will be randomised to one of two arms: the experimental treatment arm (Dynamic Therapy) (n=60) or the usual care arm (n=60). Child participants in the experimental treatment arm will receive Dynamic therapy totalling 18 hours over five consecutive weeks (target = 4 sessions per week for 4 weeks, while allowing for five weeks to achieve the 18 total sessions). Prior to receiving the studied intervention, participants will engage in a probe data collection session (week 0/baseline). After they finish their final Dynamic Therapy session they will complete an immediate probe (completed on the same day) and one final probe session 4-weeks after their final treatment session. Electronic data will be collected about additional therapy the child may be receiving from their community-based speech pathologist on a weekly basis for the duration of their participation in this study (i.e., 9 weeks, commencing once they are in their first week of therapy). TREATMENT FIDELITY: To ensure all children are provided with the most effective treatment: - All clinicians will undergo standardised training in how to provide Dynamic Therapy. Dr Edythe Strand will watch the treating clinician’s first, second or third Dynamic Therapy session with their first participant and will provide coaching feedback. - A standardised treatment manual will be used. - Treatment fidelity will be calculated on the first and second Dynamic Therapy treatment sessions and on a randomly selected third session. Fidelity calculations will be conducted synchronously and feedback will be provided to the treating clinician via email or a video conference call regarding any changes required. Treatment fidelity will be reported.


Locations(2)

Philadelphia, United States of America

New York, United States of America

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ACTRN12621000666820


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