Clinical trial NCT05675306: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Hofstra University
name: New York University
name: University of Vermont
name: University of Sydney
name: Remarkable Speech and Movement
First posted: 2023-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand \& McCauley, 2019),
2. 2;6-7;11 years of age at treatment commencement;
3. English as the primary language;

Exclusion Criteria:

1. concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
2. diagnosis of severe or primary dysarthria as described below;
3. palatal or structural orofacial anomalies as described below,
4. uncorrected vision impairment
5. hearing loss;
6. 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
7. 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,
8. Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds \& Kamphaus, 2015), and
9. no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.

Primary outcomes:
measure: Changes to whole word accuracy
timeFrame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Secondary outcomes:
measure: Phoneme accuracy
timeFrame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
measure: Speech Intelligibility
timeFrame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
measure: Functional communication
timeFrame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette U
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Jenya Iuzzini-Seigel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.
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.
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.
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.
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.
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.
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.
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.
citation: Goldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.
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.
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.
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
citation: Wiig, E. H., Semel, E. M., & Secord, W. A. (2013). Clinical Evaluation of Language Fundamentals - 5. Pearson.