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Dose Frequency RCT on DTTC in Children With CAS

Primary Purpose

Childhood Apraxia of Speech

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Temporal and Tactile Cueing Treatment
Sponsored by
Marquette 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 treatment, dose frequency, speech sound disorders, cumulative dosage, whole word accuracy, Dynamic Temporal and Tactile Cueing, DTTC, Childhood apraxia of speech

Eligibility Criteria

30 Months - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand & McCauley, 2019), 2;6-7;11 years of age at treatment commencement; English as the primary language; Exclusion Criteria: concomitant developmental disorders (including autism, global developmental delay, intellectual disability); diagnosis of severe or primary dysarthria as described below; palatal or structural orofacial anomalies as described below, uncorrected vision impairment hearing loss; receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age, Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds & Kamphaus, 2015), and no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.

Sites / Locations

  • Marquette URecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Dose Frequency

Low Dose Frequency

Arm Description

This group will receive treatment 4x/week for 6 weeks

This group will receive treatment 2x/week for 12 weeks

Outcomes

Primary Outcome Measures

Changes to whole word accuracy
A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe.

Secondary Outcome Measures

Phoneme accuracy
Percentage of phonemes correct on the generalization probe
Speech Intelligibility
Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure
Functional communication
Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure

Full Information

First Posted
December 22, 2022
Last Updated
July 25, 2023
Sponsor
Marquette University
Collaborators
Hofstra University, New York University, University of Vermont, University of Sydney, Remarkable Speech and Movement
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1. Study Identification

Unique Protocol Identification Number
NCT05675306
Brief Title
Dose Frequency RCT on DTTC in Children With CAS
Official Title
Dose Frequency Randomized Control Trial for Dynamic Temporal and Tactile Cueing (DTTC) Treatment for Childhood Apraxia of Speech
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marquette University
Collaborators
Hofstra University, New York University, University of Vermont, University of Sydney, Remarkable Speech and Movement

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
Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the use of Dynamic Temporal and Tactile Cueing (DTTC; Strand, 2020). To date, a rigorous and systematic comparison of high and low dose frequency has not been undertaken for DTTC, resulting in a lack of evidence to guide decisions about the optimal treatment schedule for this intervention. The current study aims to fill this gap in knowledge by comparing treatment outcomes when dose frequency is varied. The goal of this clinical trial is to determine whether the number of treatment sessions per week has an effect on intervention outcomes in 60 children with CAS. The main question this research will address is whether whole word accuracy will differ between two groups of children undergoing DTTC treatment when one group of children receives treatment twice a week for 12 weeks and the other group receives treatment 4 times a week for 6 weeks. Community clinicians will administer all treatment sessions.
Detailed Description
Sixty children with childhood apraxia of speech will be treated with DTTC treatment. A Phase III randomized controlled trial with parallel groups will be conducted to compare effects of low versus high dose frequency on DTTC treatment outcomes in children with CAS. Children with CAS between 2;5-7;11 years of age will be recruited to participate in this study. Treatment will be provided in the community setting by speech-language pathologists who have completed specialized training administering DTTC in a research reliable manner. True randomization with concealed allocation will be used to assign children to either the low or high dose frequency group. Treatment will be administered in 1-hour sessions either 4 times per week over a 6-week period (high dose) or 2 times per week over a 12-week period (low dose) for a total of 24 hours per child. To measure treatment gains, probe data will be collected before treatment, during treatment, and 1 day, 1 week, 4 weeks, and 12 weeks post-treatment. Probe data will consist of customized treated words and a standard set of untreated words to assess generalization of treatment gains. The primary outcome variable will be whole word accuracy, a measure of segmental, phonotactic, and suprasegmental accuracy. This will be the first randomized controlled trial (RCT) to evaluate dose frequency for DTTC treatment in children with CAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Apraxia of Speech
Keywords
treatment, dose frequency, speech sound disorders, cumulative dosage, whole word accuracy, Dynamic Temporal and Tactile Cueing, DTTC, Childhood apraxia of speech

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed work is multisite Phase III parallel-group RCT that aims to investigate the outcomes of DTTC in children with CAS and determine whether dose frequency impacts response to treatment.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose Frequency
Arm Type
Experimental
Arm Description
This group will receive treatment 4x/week for 6 weeks
Arm Title
Low Dose Frequency
Arm Type
Active Comparator
Arm Description
This group will receive treatment 2x/week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Temporal and Tactile Cueing Treatment
Other Intervention Name(s)
DTTC
Intervention Description
DTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal & Gildersleeve-Neumann, 2011; Maas & Farinella, 2012; Maas et al., 2019; Strand & Debertine, 2000; Strand & Skinder, 1999), in which the clinician instructs the child to "listen to me, watch me, and do what I do" and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020).
Primary Outcome Measure Information:
Title
Changes to whole word accuracy
Description
A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe.
Time Frame
Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Secondary Outcome Measure Information:
Title
Phoneme accuracy
Description
Percentage of phonemes correct on the generalization probe
Time Frame
Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Title
Speech Intelligibility
Description
Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure
Time Frame
Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
Title
Functional communication
Description
Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure
Time Frame
Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand & McCauley, 2019), 2;6-7;11 years of age at treatment commencement; English as the primary language; Exclusion Criteria: concomitant developmental disorders (including autism, global developmental delay, intellectual disability); diagnosis of severe or primary dysarthria as described below; palatal or structural orofacial anomalies as described below, uncorrected vision impairment hearing loss; receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age, Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds & Kamphaus, 2015), and no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenya Iuzzini-Seigel, PhD
Phone
4142881528
Email
jenya.iuzzini-seigel@marquette.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Case, PhD
Phone
5164635507
Email
julie.case@hofstra.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenya Iuzzini-Seigel, PhD
Organizational Affiliation
Marquette University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marquette U
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby Anumandla
Email
shelby.anumandla@marquette.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual level data will be shared.
IPD Sharing Time Frame
Beginning 6 months after publication. No end date.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal and evidence of ethical conduct of research and appropriate institutional oversight (e.g., IRB). Proposals should be directed to jenya.iuzzini-seigel@marquette.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.
Citations:
Citation
Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.
Results Reference
background
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
result
PubMed Identifier
25313348
Citation
Maas E, Gildersleeve-Neumann C, Jakielski KJ, Stoeckel R. Motor-based intervention protocols in treatment of childhood apraxia of speech (CAS). Curr Dev Disord Rep. 2014 Sep;1(3):197-206. doi: 10.1007/s40474-014-0016-4.
Results Reference
result
PubMed Identifier
21330650
Citation
Edeal DM, Gildersleeve-Neumann CE. The importance of production frequency in therapy for childhood apraxia of speech. Am J Speech Lang Pathol. 2011 May;20(2):95-110. doi: 10.1044/1058-0360(2011/09-0005). Epub 2011 Feb 17.
Results Reference
result
PubMed Identifier
22207698
Citation
Maas E, Farinella KA. Random versus blocked practice in treatment for childhood apraxia of speech. J Speech Lang Hear Res. 2012 Apr;55(2):561-78. doi: 10.1044/1092-4388(2011/11-0120). Epub 2011 Dec 29.
Results Reference
result
PubMed Identifier
31425660
Citation
Maas E, Gildersleeve-Neumann C, Jakielski K, Kovacs N, Stoeckel R, Vradelis H, Welsh M. Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech. J Speech Lang Hear Res. 2019 Sep 20;62(9):3160-3182. doi: 10.1044/2019_JSLHR-S-18-0212. Epub 2019 Aug 19.
Results Reference
result
PubMed Identifier
35523425
Citation
Iuzzini-Seigel J, Allison KM, Stoeckel R. A Tool for Differential Diagnosis of Childhood Apraxia of Speech and Dysarthria in Children: A Tutorial. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):926-946. doi: 10.1044/2022_LSHSS-21-00164. Epub 2022 May 6.
Results Reference
result
PubMed Identifier
28384695
Citation
Shriberg LD, Strand EA, Fourakis M, Jakielski KJ, Hall SD, Karlsson HB, Mabie HL, McSweeny JL, Tilkens CM, Wilson DL. A Diagnostic Marker to Discriminate Childhood Apraxia of Speech From Speech Delay: Introduction. J Speech Lang Hear Res. 2017 Apr 14;60(4):S1094-S1095. doi: 10.1044/2016_JSLHR-S-16-0148.
Results Reference
result
Citation
Goldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.
Results Reference
result
Citation
Strand, E. A., & Debertine, P. (2000). The efficacy of integral stimulation intervention with developmental apraxia of speech. Journal of Medical Speech-Language Pathology, 8(4), 295-300.
Results Reference
result
PubMed Identifier
34237603
Citation
Gubiani MB, Pagliarin KC, McCauley RJ, Keske-Soares M. Dynamic Evaluation of Motor Speech Skill: Adaptation for Brazilian Portuguese. J Commun Disord. 2021 Sep-Oct;93:106114. doi: 10.1016/j.jcomdis.2021.106114. Epub 2021 May 24.
Results Reference
result
Citation
Thomas-Stonell, N., Oddson, B., Robertson, B., Walker, J. & Rosenbaum, P. (2015). The FOCUS©-34: Focus on the Outcomes of Communication Under Six. Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON. http://www.focusoutcomemeasurement.ca
Results Reference
result
Citation
Wiig, E. H., Semel, E. M., & Secord, W. A. (2013). Clinical Evaluation of Language Fundamentals - 5. Pearson.
Results Reference
result

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Dose Frequency RCT on DTTC in Children With CAS

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