search
Back to results

The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS (DTTC)

Primary Purpose

Childhood Apraxia of Speech

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Temporal and Tactile Cueing (DTTC)
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Apraxia of Speech focused on measuring Children, Speech, Intervention

Eligibility Criteria

24 Months - 95 Months (Child)All SexesDoes not accept healthy volunteers

Child Eligibility Inclusion Criteria 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 Exclusion Criteria 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

Sites / Locations

  • Hofstra UniversityRecruiting
  • New York UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Indirect Training (DTTC + Home Practice)

Direct Training (DTTC + Coaching + Home Practice)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
June 14, 2023
Last Updated
July 24, 2023
Sponsor
New York University
Collaborators
Hofstra University
search

1. Study Identification

Unique Protocol Identification Number
NCT05916222
Brief Title
The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS
Acronym
DTTC
Official Title
The Effects of Caregiver Training on Dynamic Temporal and Tactile Cueing (DTTC) Treatment Outcomes in Childhood Apraxia of Speech (CAS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
Hofstra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Apraxia of Speech
Keywords
Children, Speech, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indirect Training (DTTC + Home Practice)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Direct Training (DTTC + Coaching + Home Practice)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Temporal and Tactile Cueing (DTTC)
Other Intervention Name(s)
DTTC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in word accuracy
Description
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).
Time Frame
Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up
Secondary Outcome Measure Information:
Title
Changes in phoneme accuracy
Description
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).
Time Frame
Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up
Title
Changes in speech intelligibility
Description
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).
Time Frame
Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up
Title
Changes in the FOCUS-34 score
Description
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).
Time Frame
Pre- to post-treatment (16 treatment sessions over 8 weeks); 1-week and 4-week post-treatment follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
95 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Child Eligibility Inclusion Criteria 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 Exclusion Criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria I Grigos, PhD
Phone
212.998.5228
Email
maria.grigos@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Case, PhD
Phone
516.463.5507
Email
julie.case@hostra.edu
Facility Information:
Facility Name
Hofstra University
City
Hempstead
State/Province
New York
ZIP/Postal Code
11549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Sullivan, M.S.
Email
ks5904@nyu.edu
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Sullivan, M.S.
Email
ks5904@nyu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data tied to the primary and secondary outcome measures will be shared after deidentification.
IPD Sharing Time Frame
Beginning 6 months following publication. No end date.
IPD Sharing 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.
Citations:
PubMed Identifier
31846588
Citation
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.
Results Reference
background
PubMed Identifier
37195724
Citation
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.
Results Reference
background
PubMed Identifier
22215036
Citation
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.
Results Reference
background
PubMed Identifier
23763248
Citation
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.
Results Reference
background

Learn more about this trial

The Effects of Caregiver Training on DTTC Treatment Outcomes in CAS

We'll reach out to this number within 24 hrs