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Trial registered on ANZCTR


Registration number
ACTRN12615000102572
Ethics application status
Approved
Date submitted
15/01/2015
Date registered
5/02/2015
Date last updated
4/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of parent and tutor training in the treatment of Childhood Apraxia of Speech.
Scientific title
The impact of training parents and tutors to deliver the treatment protocol, Dynamic Temporal and Tactile Cueing (DTTC) in improving the speech skills of children with Childhood Apraxia of Speech.
Secondary ID [1] 285909 0
2014/924
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 293830 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294131 294131 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study explores the effectiveness of training parents and school tutors to use the treatment strategy, Dynamic Temporal and Tactile Cueing (DTTC) to improve the speech skills of children with Childhood Apraxia of Speech (CAS). This strategy utilises the principles of motor learning to cue children with CAS to say difficult sound combinations. Parents will provide the treatment at home to the children for 15 minutes twice a day 5 days a week in two 4 week blocks. School tutors will provide the treatment at school in two five week blocks. Both parents and tutors will be trained in direct one-to-one sessions with one of the researchers who is also a speech pathologist. These training sessions will be for 1 hour a week over 4 weeks.

The outline for the study is as follows:
* 4-5 weeks of baseline data collection (probe data is collected from the child once a week to obtain a stable baseline)
* 4 weeks of training. This takes place in the clinic or school with the parent or tutor and the child attending for 1-2 hours once a week.
* 4-5 weeks of home or school treatment. Parents work with the children in the home and the tutors work with their students at school. 15 minutes twice a day, five days a week. Probe data is collected once a week.
* 2 week maintenance period. No therapy is done. Probe data is still collected once a week.
* 4-5 weeks home or school treatment. Parents and tutors will work on a second set of target words. Probe data is still collected each week.
* 4 weeks maintenance. No therapy is conducted. Probe data is still collected once a week. At the end of this period, the post assessment data is collected. This is done either at school or at the clinic.
The researchers will maintain regular contact with the parents and tutors to monitor their adherence to the intervention.
Intervention code [1] 290887 0
Rehabilitation
Intervention code [2] 291028 0
Treatment: Other
Comparator / control treatment
Not applicable. This is a within subject multiple baseline single subject design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293934 0
Percentage of speech sounds or phonemes correct in 60 probe words. The researcher will meet with each child each week to record them saying all the probe words.
Timepoint [1] 293934 0
Probe data will be collected once a week for the duration of the study which is 22 weeks from baseline to the end of the last maintenance phase
Secondary outcome [1] 312172 0
Percentage of phonemes correct of all words in probe data (target words, similar words and control words).
Timepoint [1] 312172 0
Probe data will be collected once a week for the duration of the study which is 22 weeks from baseline to the end of the study.

Eligibility
Key inclusion criteria
Criteria for the children:
Diagnosis of CAS
Normal vision (or adjusted to normal)
Hearing of at least 40dbs
English as a primary language speaker
No diagnosis of Autism Spectrum Disorder

Criteria for the parents and tutors:
English is their first language
No known speech related issues.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Autism Spectrum Disorder in the children.

Parent and tutor exclusion criteria:
Does not speak English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a multiple baseline across participants single subject design. Participants will be recruited from the current caseload or waiting list of the Speech Pathology Department at the Mamawetan Churchill River Health Region, Saskatchewan, Canada. They will be handed an information flyer by someone independent to the study when they arrive for a therapy appointment. They will be asked to contact the local researcher if they have more questions. If they agree to participate in the study, a pre-test battery of assessments will be undertaken to determine their eligibility. If they are eligible and consent is obtained, they will be entered into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single subject multiple baseline across participants study design. Randomisation is obtained through the study design rather than allocation of participants. For instance, there are two treatment blocks and treatment words are randomly assigned to the different treatment blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Visual analysis
Improvement Rate Difference

Single subject experimental designs (SSED) are built on the premise of a small number of participants. They are a useful and legitimate form of clinical research (Byiers, Reichle, & Symons, 2012). They often help to establish the realistic clinical applications of a treatment regime in the messy world of real world clinical circumstances. They can be a useful means of evaluating the effectiveness of treatment for conditions which are rare making large scale randomised controlled trials (RCT) difficult or where scarce resources limit the ability to conduct RCT. They can also be a useful stepping stone towards RCT. However, because of their small sample size, their strength or validity (both internal and external) has to arise out of a different source other than the number of participants. Repetition is the main means by which the validity of SSED can be strengthened. Multiple baselines, several phases, multiple data points, alternating treatment designs and at least 2 participants can allow SSED studies to achieve more confidence in the strength of their results (Kratochwill et al., 2013; McReynolds & Thompson). Building in randomisation into the design of the SSED study also allows for greater confidence in the results. The What Works Clearinghouse (WWC) which was established by the Institute for Education Sciences (IES), has developed a guide in determining the effectiveness of SSED studies (Kratochwill et al., 2013). Multiple baseline SSED studies are said to have met the standards when they have at least 6 phases with at least 5 data points.
In our study, these standards are met in the following ways:
* By having at least 4 participants with 6 phases each (baseline, parent /tutor training, parent treatment phase 1, no treatment, parent/tutor treatment phase 2, maintenance), our study has built in replication into the design of the study.
* Our study will also have at least 5 data points per phase allowing for adequate comparison of results.
* By having multiple baselines across participants, our study has built in randomisation in terms of the start of the treatment phase.
* There will be randomisation in terms of which treatment word list is targeted first
* There will be randomisation in terms of which participant starts first.

Byiers, B. J., Reichle, J., & Symons, F. J. (2012). Single-Subject Experimental Design for Evidene-Based Practice. American Journal of Speech-Language Pathology, 21(November), 397-414.
Kratochwill, T. R., Hitchcock, J. H., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M., & Shadish, W. R. (2013). Single-case intervention research design standards. Remedial and Special Education, 34(1), 26-38.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2015
Actual
16/02/2015
Date of last participant enrolment
Anticipated
Actual
1/02/2018
Date of last data collection
Anticipated
Actual
30/04/2018
Sample size
Target
8
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 6577 0
Canada
State/province [1] 6577 0
Saskatchewan

Funding & Sponsors
Funding source category [1] 290509 0
Self funded/Unfunded
Name [1] 290509 0
Jacqueline Lim
PhD Candidate
Speech Pathology
Faculty of Health Sciences
University of Sydney
Country [1] 290509 0
Australia
Primary sponsor type
University
Name
Faculty of Health Sciences, The University of Sydney
Address
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Australia
Country
Australia
Secondary sponsor category [1] 289192 0
Hospital
Name [1] 289192 0
La Ronge Health Centre
Mamawetan Churchill River Health Region
Address [1] 289192 0
Box 6000
La Ronge
S0J 1L0
SK
Canada
Country [1] 289192 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292152 0
The University of Sydney Human Research Ethics Comittee
Ethics committee address [1] 292152 0
Ethics committee country [1] 292152 0
Australia
Date submitted for ethics approval [1] 292152 0
29/10/2014
Approval date [1] 292152 0
12/01/2015
Ethics approval number [1] 292152 0
2014/924

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53782 0
A/Prof Patricia McCabe
Address 53782 0
The Faculty of Health Sciences
The University of Sydney
Box 170 Lidcombe
NSW 1825
Australia
Country 53782 0
Australia
Phone 53782 0
+61 2 9351 9173
Fax 53782 0
Email 53782 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 53783 0
Patricia McCabe
Address 53783 0
The Faculty of Health Sciences
The University of Sydney
Box 170 Lidcombe
NSW 1825
Australia
Country 53783 0
Australia
Phone 53783 0
+61 2 9351 9173
Fax 53783 0
Email 53783 0
tricia.mccabe@sydney.edu.au
Contact person for scientific queries
Name 53784 0
Patricia McCabe
Address 53784 0
The Faculty of Health Sciences
The University of Sydney
Box 170 Lidcombe
NSW 1825
Australia
Country 53784 0
Australia
Phone 53784 0
+61 2 9351 9173
Fax 53784 0
Email 53784 0
tricia.mccabe@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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