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Childhood Apraxia of SpeechDTTCNCT05916222

The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS

A study testing Dynamic Temporal and Tactile Cueing (DTTC) in people with Childhood Apraxia of Speech, run by New York University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to investigate the impact of direct vs. indirect caregiver training on treatment outcomes following a period of Dynamic Temporal and Tactile Cueing (DTTC) intervention combined with home practice in childhood apraxia of speech (CAS). Read more about this study

Who is it for?
Ages 24 to 95 months
Conditions the study is for
Childhood Apraxia of Speech
What is being tested?
Dynamic Temporal and Tactile Cueing (DTTC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
19 Jul 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 95 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 2;6-7;11 years of age at the start of treatment
  • English as the primary and preferred language
  • Primary speech diagnosis of CAS based on auditory-perceptual, expert diagnosis and/or Dynamic Evaluation of Motor Speech Skills (DEMSS) score classification of "significant evidence of CAS" with score <323

Who cannot join

  • Concomitant disorders including autism spectrum disorder, global development delay, or intellectual disability, Down syndrome, or other genetic condition (diagnosis of Attention Deficit and Hyperactivity Disorder (ADHD) is allowable if the child can attend in sessions with medication and/or strategies)
  • Primary diagnosis of dysarthria or other speech sound disorder (e.g., phonological impairment).
  • Oral structural anomalies
  • Hearing impairment
  • Uncorrected visual impairment
  • Receiving speech treatment elsewhere during the period of the study. Language or Augmentative and Alternative Communication (AAC) treatment is permitted.
  • Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test - 4th Edition (REEL-4), Clinical Evaluation of Language Fundamentals - Preschool 3rd Edition (CELF-P3), or Clinical Evaluation of Language Fundamentals - 5th Edition (CELF-5), as appropriate for participant's age.
  • Cognitive standard score less than 70 on the Developmental Assessment of Young Children (DAYC) - ages 2;0 - 5;11, Nonverbal Index of Reynolds Intellectual Assessment Scales - 2nd Edition - age 6;0 - 7;11

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Hofstra University

    Hempstead, New York, 11549

  • New York University

    New York, New York, 10012

Other trials in United States

About this study

Official title: The Effects of Caregiver Training on Dynamic Temporal and Tactile Cueing (DTTC) Treatment Outcomes in Childhood Apraxia of Speech (CAS)

The goal of this clinical trial is to investigate the impact of direct vs. indirect caregiver training on treatment outcomes following a period of Dynamic Temporal and Tactile Cueing (DTTC) intervention combined with home practice in childhood apraxia of speech (CAS). Forty children with CAS, between the ages of 2;5 and 7;11 years of age, will be recruited for this study. All children will receive DTTC treatment at the frequency of standard care (2x/week) in a university clinic over and 8-week period. Participants will be randomly assigned to one of two groups: the Direct Training Group; the Indirect Training Group. All caregivers will complete an educational module about CAS, will observe all sessions, and will engage in home practice with their children. Caregivers in the Direct Group will receive coaching in the use of DTTC with their child during a portion of each treatment session to support home practice, whereas those in the Indirect Group will not receive detailed guidance for home practice. Caregivers in both groups will practice at home with their children during the treatment phase (3x/week). Following the treatment phase, home practice will continue at a higher frequency (6x/week) during a 4-week follow-up phase. Treatment outcomes will be compared between groups.

Read the detailed description

Forty children with CAS, between 2;5 and 7;11 years of age will receive DTTC treatment 2x/week over an 8-week period along with home practice with a caregiver. Prior to treatment, all caregivers will complete an online self-guided educational module about CAS and DTTC. Participants will be randomized to one of two groups: 1) Direct Training Group (DTTC + Home Practice + Direct Caregiver Training); 2) Indirect Training Group (DTTC + Home Practice + Indirect Caregiver Training).

Children in the Direct Training Group will receive DTTC treatment during one half of each session administered only by the SLP, while the caregiver observes. DTTC will be administered by the caregiver with direct coaching by the speech language pathologist (SLP) in the other half of the session. Children in the Indirect Training Group will only receive DTTC treatment administered by the SLP, while the caregiver observes. In both groups, caregivers will review home practice guidelines with the clinician at the end of each therapy session, and engage in home practice with their children. Home practice will consist of 30-minute practice sessions 3x/week during the 8-week treatment phase and 6x/week during the 4-week follow-up phase. Caregivers in the Direct Training Group will be provided specific guidance regarding practice techniques, whereas caregivers in the Indirect Training Group will only be provided treatment words to be practiced at home and instructed to apply what they have observed during SLP-administered DTTC.

Probe data will be collected during the Pre-Treatment, Treatment and Follow-Up phases. The study duration is 16 weeks in total duration, for all participants. Probe words will consist of 20 potential treated items to evaluate treatment gains and 30 generalization items to assess carryover of treatment gains to untreated words.

The study will address the following aims:

Aim 1: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on whole word accuracy in treated and generalization probes at post-treatment and maintenance.

Aim 2: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on phoneme accuracy in treated words and generalization probes at post-treatment and maintenance.

Aim 3: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on speech intelligibility at post-treatment and maintenance.

Aim 4: Quantify the effects of direct vs. indirect caregiver training during a period of DTTC combined with home practice on functional communication at post-treatment and maintenance.

Being tested
Dynamic Temporal and Tactile Cueing (DTTC)
Keywords
Children, Speech, Intervention
Medical subject headings
Apraxias, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Temporal and Tactile Cueing (DTTC)Behavioural

    Also called DTTC

    DTTC is a motor-based intervention where the client watches, listens to and imitates the clinician (Strand, 2020). Treatment follows a temporal hierarchy where children receive multisensory cueing to establish accurate movements. First, the child imitates the clinician's production. If inaccurate, the child simultaneously produces the target with the clinician while cueing is provided. Upon achieving accuracy within simultaneous productions, the target is practiced within direct imitation while the clinician adds/fades cues based on the child's productions. When the child accurately produces the target in direct imitation, the target is practiced with varied prosody. Next, the target is practiced within delayed imitation where a child produces a word following a 2-3 second delay after the clinician's production. Upon accurately producing the target at all levels, the word is practiced within spontaneous productions.

Study groups in NCT05916222
Study groupRoleWhat they receive
Indirect Training (DTTC + Home Practice)Active comparatorChildren in the Indirect Training Arm will receive DTTC treatment 2x/week administered by an SLP for 8 weeks. Parent/caregivers in this Arm will complete an online, self-paced educational module on CAS prior to the start of treatment, observe all treatment sessions, and review home practice guidelines with the clinician at the end of each therapy session. Parent/caregivers will engage their children in home practice during the treatment phase and follow-up phase. Home practice will consist of 30-minute practice sessions 3x/week during the 8-week treatment phase and 6x/week during the 4-week follow-up phase.
Receives: Behavioral: Dynamic Temporal and Tactile Cueing (DTTC)
Direct Training (DTTC + Coaching + Home Practice)ExperimentalChildren in the Direct Training Arm will receive DTTC treatment 2x/week for 8 weeks with half of each session administered only by the SLP. In the other half of the session, DTTC will be administered by the parent/caregiver with online coaching by the SLP. During the coaching portion of treatment sessions, the SLP will provide direct training to guide the parent/caregiver in the administration of DTTC to support home practice sessions. Parent/caregivers in this Arm will also complete an online, self-paced educational module on CAS prior to the start of treatment and review home practice guidelines with the clinician at the end of each therapy session. Parent/caregivers will engage their children in home practice during the treatment phase and follow-up phase. Home practice will consist of 30-minute practice sessions 3x/week during the 8-week treatment phase and 6x/week during the 4-week follow-up phase.
Receives: Behavioral: Dynamic Temporal and Tactile Cueing (DTTC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in word accuracy

    A multi-factor whole-word accuracy measure (Multilevel word Accuracy Composite Scale (MACS); Case et al., in press) of segmental accuracy, word shape maintenance, prosodic accuracy, and smoothness/fluency of movement transitions will be calculated for treated and generalization words. A MACS score ranges from 0 (all inaccurate) to 1.0 (all accurate). The higher the MACS score is to 1, the more accurate the production would be for that word. Judgments of word accuracy will be made by anonymous raters. The MACS will be used to address Aim 1(effect of DTTC combined with parent/caregiver coaching on speech production accuracy).

    Measured: Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up

Secondary outcomes (3)
  1. Changes in phoneme accuracy

    Percentage of accurate phonemes will be calculated for treated and generalization words. Judgments of phoneme accuracy will be made by anonymous raters. Phoneme accuracy will be used to address Aim 2 (effect of DTTC combined with parent/caregiver coaching on phoneme accuracy).

    Measured: Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up

  2. Changes in speech intelligibility

    The Intelligibility in Context Scale (ICS; McLeod et al., 2012), a parent report measure of children's intelligibility, will be administered. An ICS score ranges from 1.0 (low intelligibility) to 5.0 (high intelligibility).The ICS will be used to address Aim 3 (effect of DTTC combined with parent/caregiver coaching on speech intelligibility).

    Measured: Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up

  3. Changes in the FOCUS-34 score

    The Functional Outcomes on Communication Under Six (FOCUS-34; Thomas-Stonell et al., 2015), a parent survey measure, will be administered to examine change in children's communication skills. The FOCUS-34 will be used to address Aim 4 (effect of DTTC combined with parent/caregiver coaching on functional communication).

    Measured: Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start19 Jul 2023
  3. Primary completion30 May 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This proposed work is multisite parallel-group randomized control trial (RCT) that aims to investigate the impact of parent/caregiver involvement on DTTC treatment outcomes in children with CAS. Participants will be seen in two groups: 1) Direct Training Group (DTTC + Home Practice + Direct Caregiver Training); 2) Indirect Training Group (DTTC + Home Practice + Indirect Caregiver Training).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916222
Sponsor's protocol ID
A22-0040-001
Acronym
DTTC
Status last verified
Jan 2026
First submitted
14 Jun 2023
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data tied to the primary and secondary outcome measures will be shared after deidentification.

Publications

  • Strand EA. Dynamic Temporal and Tactile Cueing: A Treatment Strategy for Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2020 Feb 7;29(1):30-48. doi: 10.1044/2019_AJSLP-19-0005. Epub 2019 Dec 17.

    PubMed 31846588
  • Case J, Wang EW, Grigos MI. The Multilevel Word Accuracy Composite Scale: A Novel Measure of Speech Production in Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2023 Aug 17;32(4S):1866-1883. doi: 10.1044/2023_AJSLP-22-00166. Epub 2023 May 17.

    PubMed 37195724
  • McLeod S, Harrison LJ, McCormack J. The intelligibility in Context Scale: validity and reliability of a subjective rating measure. J Speech Lang Hear Res. 2012 Apr;55(2):648-56. doi: 10.1044/1092-4388(2011/10-0130). Epub 2012 Jan 3.

    PubMed 22215036
  • Thomas-Stonell N, Washington K, Oddson B, Robertson B, Rosenbaum P. Measuring communicative participation using the FOCUS(c): Focus on the Outcomes of Communication Under Six. Child Care Health Dev. 2013 Jul;39(4):474-80. doi: 10.1111/cch.12049.

    PubMed 23763248

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Temporal and Tactile Cueing (DTTC) in people with Childhood Apraxia of Speech, run by New York University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in word accuracy (time frame: Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916222, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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