Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001268730
Ethics application status
Approved
Date submitted
14/11/2013
Date registered
18/11/2013
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the effectiveness of a phonological awareness teaching program for the kindergarten classroom
Scientific title
For kindergarten children, is a classroom based phonological awareness programme more effective than a control oral language programme in developing phonological awareness skills.
Secondary ID [1] 283594 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral language delay 290514 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290903 290903 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the effectiveness of the Cracking the Code (CtC) Program (Fremantle Language Development Centre (FLDC) Outreach Service, 2013) with kindergarten students aged between 3 years and 6 months and 5 years and 6 months. CtC is a teacher implemented program, designed to explicitly target Phonological Awareness (PA) skills and alphabet knowledge over an 18 week period, within a structured intervention regime. A randomised, parallel group design will be used to evaluate the effectiveness of the program and to identify factors which influence a participant’s responsiveness to the program. Four mainstream schools within the South West Perth metropolitan area will be selected to participate in the study. Schools involved in the study will be matched based on the following characteristics; (1) geographical location, (2) socioeconomic status and (3) educational outcomes. Between 100 – 120 kindergarten students aged between 3 years and 6 months and 4 years and 6 months on entry to the programme will be included within the final data set with parental/caregiver consent. The schools will be randomly assigned to either the control or treatment condition. The control group will participate in an alternative program matched for duration and intensity, targeting the areas of semantics and grammar. All participants will be assessed on PA, alphabet knowledge, non word reading and spelling, oral language, and short term memory prior to intervention, and on PA, alphabet knowledge, non-word reading and spelling after intervention.
The language programs involve;
1. Six intervention blocks each lasting for 3 weeks (18 weeks in total). The intervention phase runs over Term 2 and Term 3.
2. Then intervention blocks begin at the level of onset and rime and progress towards phonemic awareness activities, following a developmental progression of these skills. An example of the activities in Block 4 are:
Onset-Rime (Rhyme Detection): Piggy Banks
Onset-Rime Segmentation (Initial Sound): First Sound Treasure Hunt
Phoneme Final Sound Identification: Hopscotch
Phoneme CVC Blending: Shopping Trolley

3. Activity sessions will be conducted twice per week – so six times over the three week period.
4. Each session will take approximately 40 – 55 minutes.
5. Two to three staff members will be required for the running of each session. These staff members may be teachers, education assistants or school support staff.
6. Support and training will be provided to education staff prior to the commencement of each block.

To ensure treatment fidelity, clear guidelines for dosage and implementation, as well as comprehensive training and modelling support, will be provided. The procedures manuals for the language programmes will be used in training to support adherence to the treatment protocol. Teacher questionnaires, recorded use of activities and direct observations of lessons every three weeks, by the primary researcher will also contribute to treatment fidelity.
Intervention code [1] 288283 0
Other interventions
Comparator / control treatment
Words, Grammar and Fun - will be used as the control intervention programme (Fremantle Language Development Centre (FLDC) Outreach Service, 2013).
The language programs involve;
1. Six intervention blocks each lasting for 3 weeks (18 weeks in total). The intervention phase runs over Term 2 and Term 3.
2. The intervention content of Words, Grammar and Fun targets word learning with a focus on vocabulary and syntax (grammar) and morphology. It addresses different goals to the treatment condition which targets phonological awareness but is delivered at the same intensity and in the same format.
3. Activity sessions will be conducted twice per week – so six times over the three week period.
4. Each session will take approximately 40 – 55 minutes.
5. Two to three staff members will be required for the running of each session. These staff members may be teachers, education assistants or school support staff.
6. Support and training will be provided to education staff prior to the commencement of each block.
To ensure treatment fidelity, clear guidelines for dosage and implementation, as well as comprehensive training and modelling support, will be provided.
Control group
Active

Outcomes
Primary outcome [1] 290890 0
All kindergarten children will be assessed using the (1) Cracking the Code PA Assessment (FLDC Outreach Service, 2013). The CtC PA assessment assesses syllable, onset-rime and phoneme level PA. It was developed for use within the program, and assesses all targeted skills. A blind assessor will be trained by the primary researcher and will be responsible for administering these assessments.
Timepoint [1] 290890 0
Within the same two-week period during term one (testing time one), and during a two week period in term four 2014 (testing time two).
Primary outcome [2] 290913 0
All kindergarten children will be assessed using (2) an alphabet knowledge assessment (name and sound). A blind assessor will be trained by the primary researcher and will be responsible for administering these assessments.
Timepoint [2] 290913 0
Within the same two-week period during term one (testing time one), and during a two week period in term four 2014 (testing time two).
Primary outcome [3] 290914 0
All kindergarten children will be assessed using (3) a simple age-appropriate early non-word reading and spelling assessment, developed for use within the program. A blind assessor will be trained by the primary researcher and will be responsible for administering these assessments.
Timepoint [3] 290914 0
Within the same two-week period during term one (testing time one), and during a two week period in term four 2014 (testing time two).
Secondary outcome [1] 305557 0
Nil
Timepoint [1] 305557 0
Nil

Eligibility
Key inclusion criteria
Four mainstream schools within the South West Perth metropolitan area will be selected to participate in the study. Schools involved in the study will be matched based on the following characteristics; (1) geographical location, (2) socioeconomic status and (3) educational outcomes. Between 100 – 120 kindergarten students aged between 3 years and 6 months and 4 years and 6 months on entry to the programme will be included within the final data set with parental/caregiver consent.
Inclusion criteria are therefore: attending the relevant class in a consenting school and parent consent.
Minimum age
42 Months
Maximum age
54 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2014
Actual
3/02/2014
Date of last participant enrolment
Anticipated
Actual
3/03/2014
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288274 0
University
Name [1] 288274 0
Curtin University
Country [1] 288274 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U 1987, Perth
Western Australia, 6845
Country
Australia
Secondary sponsor category [1] 286989 0
None
Name [1] 286989 0
Address [1] 286989 0
Country [1] 286989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290171 0
Curtin University HREC
Ethics committee address [1] 290171 0
Ethics committee country [1] 290171 0
Australia
Date submitted for ethics approval [1] 290171 0
03/12/2013
Approval date [1] 290171 0
12/12/2013
Ethics approval number [1] 290171 0

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

Contacts
Principal investigator
Name 43422 0
Dr Suze Leitao
Address 43422 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U 1987, Perth
Western Australia, 6845
Country 43422 0
Australia
Phone 43422 0
+61 8 9266 7620
Fax 43422 0
Email 43422 0
[email protected]
Contact person for public queries
Name 43423 0
Suze Leitao
Address 43423 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U 1987, Perth
Western Australia, 6845
Country 43423 0
Australia
Phone 43423 0
+61 8 9266 7620
Fax 43423 0
Email 43423 0
[email protected]
Contact person for scientific queries
Name 43424 0
Suze Leitao
Address 43424 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U 1987, Perth
Western Australia, 6845
Country 43424 0
Australia
Phone 43424 0
+61 8 9266 7620
Fax 43424 0
Email 43424 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.