The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS

NCT05916222 | Recruiting

• 1 other identifier: A22-0040-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Childhood Apraxia of Speech

Keywords

Children; Speech; Intervention

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (3)

• Changes in phoneme accuracy

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

• Changes in speech intelligibility

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

• Changes in the FOCUS-34 score

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

Study Arms (2)

Indirect Training (DTTC + Home Practice)

ACTIVE COMPARATOR

Children 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.

Behavioral: Dynamic Temporal and Tactile Cueing (DTTC)

Direct Training (DTTC + Coaching + Home Practice)

EXPERIMENTAL

Children 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.

Behavioral: Dynamic Temporal and Tactile Cueing (DTTC)

Interventions

Dynamic Temporal and Tactile Cueing (DTTC) BEHAVIORAL

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.

Also known as: DTTC

Direct Training (DTTC + Coaching + Home Practice); Indirect Training (DTTC + Home Practice)

Eligibility Criteria

• Age: 24 Months - 95 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ;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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hofstra University: collaborator
• New York University: lead

Study Sites (2)

Hofstra University

Hempstead, New York, 11549, United States

RECRUITING

New York University

New York, New York, 10012, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31846588 BACKGROUND

• 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.

  PMID: 37195724 BACKGROUND

• 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.

  PMID: 22215036 BACKGROUND

• 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.

  PMID: 23763248 BACKGROUND

MeSH Terms

Conditions

Apraxias; Speech

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Central Study Contacts

Maria I Grigos, PhD

CONTACT

212.998.5228; maria.grigos@nyu.edu

Julie Case, PhD

CONTACT

516.463.5507; julie.case@hostra.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will be unaware of participant grouping (i.e., Direct Training Group, Indirect Training Group), treatment phase (i.e., baseline, treatment, follow-up), or status of words (i.e., treated, generalization words).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: July 19, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months following publication. No end date.
• Access Criteria: Researchers and speech language pathologists who provide a methodologically sound proposal. Proposals should be directed to maria.grigos@nyu.edu and julie.case@hofstra.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.

Locations

US (2)