Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000179336
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
2/02/2017
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Building Better Readers: testing the value of MiniLit for Year 1 students with low reading ability
Scientific title
The efficicacy of MiniLit in improving reading ability for Year 1 students with low reading ability
Secondary ID [1] 290968 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reading difficulties 301712 0
Condition category
Condition code
Public Health 301414 301414 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MiniLit Intervention (http://www.multilit.com/programs/minilit-program/). It is classified as a Tier 2 intervention according to the Response To Intervention framework.

The reading intervention involves up to 80 unique lessons delivered by a trained intervention deliverer in face-to-face groups of up to 4 students. The intervention is delivered during school hours, on school property. The intervention deliverer is required to attend a 2-day training session and to have completed at least high school.

The starting point for each group is determined by a pre-assessment that assesses the child's reading ability, matched to the content and difficulty of the unique lessons. The program takes around 20 weeks to complete, with four lessons of up to 60 minutes per week, and includes regular curriculum-based measures to monitor the progress of the students. Each lesson comprises three main components:
1. Sounds and Words Activities
2. Text Reading
3. Story Book Reading

The resources required as part of the MiniLit intervention, are:
1. Introductory DVD (11 mins)
2. Teacher manual (78 pages)
3. Handbook (four handbooks covering 4 x 20 lessons, 1050 pages)
4. Sounds and words books (five copies of 78 pages each)
5. Presentation cards (7 different types, totalling 900 cards)
6. Student workbooks (2 x five copies of 84 pages each. Note: separate booklets are required for each student undertaking the program.
7. Testing and lesson records (2 x one copy of 88 page)

Program fidelity will be measured as part of the process evaluation by the research team. This will include the number of unique lessons completed, length of each lesson, number of lessons repeated as well as start and end lesson. This will be collected by examining the lesson plans of the MiniLit intervention deliverers.
Intervention code [1] 296922 0
Treatment: Other
Comparator / control treatment
The control children will not recieve the MiniLit intervention but may be provided with other reading support by their school. This group will referred to the 'usual teaching' group.
Control group
Active

Outcomes
Primary outcome [1] 300805 0
Child reading as measured by the York Assessment of Reading for Comprehension - Passage Reading (YARC – PR)
Timepoint [1] 300805 0
12 months post-randomisation
Secondary outcome [1] 330923 0
Child literacy domains as measured by the YARC - Early Reading
Timepoint [1] 330923 0
6 and 12 months post-randomisation
Secondary outcome [2] 330957 0
Cost-effectiveness, will be measured using actual costs incurred by the intervention group for items such as resources, personnel and travel required to deliver the intervention.
Timepoint [2] 330957 0
12 months post-randomisation

Eligibility
Key inclusion criteria
Being in the bottom 25th percentile of readers at the start of Year 1 of primary school. Defined using the Wheldall Assessment of Reading Lists and it's published cut points.
Minimum age
6 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with severe disabilities (e.g. cerebal palsy, vision/hearing impairments) that do not allow them to participate in the intervention.

Students with Language Background Other Than English (LBOTE) whose English Language abilities does not allow them to participate in the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of individual students to MiniLit versus Business as Usual groups will be concealed from members of the research team involved in outcome assessments for the duration of the project. The allocation will be conducted by an indepedent statician who is independent of the research team to ensure concealment from the research team. Once child eligibility has been determined by the research team, the statistician will randomise children with only the child's study ID.

Because school staff, teachers and students will not be blinded, they will be asked not to disclose student randomisation status to the research staff when the research staff conduct assessments at their schools. However, in cases of disclosure, this information will be recorded in the project database and ‘unblinding’ will be examined as a potential confounding variable in the outcome analyses.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be conducted by a statistician who is independent of the research team. This will involve simple randomisation using a sequence generated by statistical software, STATA.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will follow standard methods for randomised controlled trials. The primary analysis will be by intention-to-treat and will include all randomised participants where outcome data are available.

The primary outcome is student reading outcomes at 12 months post-randomisation, as measured by the YARC - PR. The primary analysis will use a multivariate linear regression to examine the YARC – PR score (continuous) at 12 months post-randomisation for the intervention students, compared to students in the control group. Both unadjusted and adjusted analyses will be conducted. For adjusted analyses, two models will be conducted. The first will account for baseline assessment scores whilst the second will also include student age, gender and family SES as a priori confounders. Family SES will be determined using the NSW Department of Education’s Student Educational Advantage score, which is derived from parent education level and occupation. This will be provided by the NSW Department of Education. Clustering of students within schools and MiniLit groups will be accounted for in the models using regression techniques that respect these structures. Findings between groups will be presented as mean differences with 95% Confidence Intervals, p-values and Hedge’s g effect sizes.

For secondary outcomes, continuous variables will be analysed using linear regression and categorical data will use logistic regression. Unadjusted and adjusting findings will be presented according to the models described in the primary outcome analyses. Given the pragmatic sample size, sub-group analyses will only be conducted if the sub-group has over 40 students per group (25% of the final sample).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2017
Actual
13/02/2017
Date of last participant enrolment
Anticipated
Actual
30/03/2017
Date of last data collection
Anticipated
6/07/2018
Actual
16/07/2018
Sample size
Target
300
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295384 0
Charities/Societies/Foundations
Name [1] 295384 0
Evidence For Learning
Country [1] 295384 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Centre for Community Child Health
Murdoch Childrens Research Institute
Flemington Road
Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 294207 0
University
Name [1] 294207 0
The University of Melbourne
Address [1] 294207 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country [1] 294207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296719 0
Royal Childrens Hospital Human Research Ethics Committee
Ethics committee address [1] 296719 0
Ethics committee country [1] 296719 0
Australia
Date submitted for ethics approval [1] 296719 0
04/10/2016
Approval date [1] 296719 0
12/11/2016
Ethics approval number [1] 296719 0
36301

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

Contacts
Principal investigator
Name 71870 0
Dr Jon Quach
Address 71870 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 71870 0
Australia
Phone 71870 0
+61383441200
Fax 71870 0
Email 71870 0
[email protected]
Contact person for public queries
Name 71871 0
Jon Quach
Address 71871 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 71871 0
Australia
Phone 71871 0
+61383441200
Fax 71871 0
Email 71871 0
[email protected]
Contact person for scientific queries
Name 71872 0
Jon Quach
Address 71872 0
Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010
Country 71872 0
Australia
Phone 71872 0
+61383441200
Fax 71872 0
Email 71872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will be determined in consulation with the Evidence For Learning Impact fund and in accordance with ethics approval from the HREC at the Royal Children's Hospital


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
SourceTitleYear of PublicationDOI
EmbaseTesting of a synthetic phonics-based targeted reading intervention for students with reading difficulties in Year 1: Protocol for an efficacy randomised controlled trial.2018https://dx.doi.org/10.1136/bmjpo-2018-000301
N.B. These documents automatically identified may not have been verified by the study sponsor.