ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000666820

Ethics application status

Approved

Date submitted

25/02/2021

Date registered

1/06/2021

Date last updated

28/01/2024

Date data sharing statement initially provided

1/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1263-0335

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Childhood Apraxia of Speech

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Behaviour

Comparator / control treatment

Usual Care Arm

Child participants in the Usual Care arm will continue their usual care which we will monitor for 9 consecutive weeks. For example, if the child was seeing a speech pathologist for one hour, once per week, prior to their involvement in this study, they can continue that care, although they are able to change or discontinue therapy as they wish. Electronic data will be collected on a weekly basis for participants in the Usual Care arm from either the treating speech pathologist or from their parent. Treatment data collected during this period will include treatment used, treatment goals, therapy progress and minutes of therapy per week the child attended. Other data collected from the community-based (i.e., usual care) treating speech pathologist will include their demographic data such as the speech pathologist’s highest level of qualification and their experience treating Childhood Apraxia of Speech. Children in this arm will complete probes at the beginning of the trial (pre-probe), at 5 weeks and at 9 weeks.

Usual Care Data Collection for all Participants

Although children will be randomised to one of the two arms (experimental treatment arm or Usual Care arm), the usual care questionnaire will be completed by community-based speech pathologists/family for all enrolled children to collect data for their entire enrolment period (starting from their first week).

Control group

Active

Outcomes

Primary outcome [1]

Percentage of Phonemes Correct (PPC) will be calculated for treatment words and will be assessed for changes.

Instrument: Treatment words targeted in therapy will be recorded by the speech pathologist using a Single word assessment tool (Generalisation Probe created by the research team).

Timepoint [1]