ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Reading difficulties

Condition category

Condition code

Public Health

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]

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]

Child reading as measured by the York Assessment of Reading for Comprehension - Passage Reading (YARC – PR)

Timepoint [1]

12 months post-randomisation

Secondary outcome [1]

Child literacy domains as measured by the YARC - Early Reading

Timepoint [1]

6 and 12 months post-randomisation

Secondary outcome [2]

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]

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]

Charities/Societies/Foundations

Name [1]

Evidence For Learning

Address [1]

Level 6, 6 O’Connell Street, Sydney NSW 2000

Country [1]

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]

University

Name [1]

The University of Melbourne

Address [1]

Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Childrens Hospital Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Office
Royal Childrens Hospital
Flemington Road
Parkville, Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/10/2016

Approval date [1]

12/11/2016

Ethics approval number [1]

36301

Summary

Brief summary

A number of studies have examined the impact of the MiniLit program on the reading ability of students participating in the program. Although these previous studies have shown promising benefits in terms of effect sizes on children’s reading (d = 1.1 to 1.8), results are derived from differences between pre- and post-training scores. In addition, there has been limited efficacy and effectiveness studies that compare children who complete MiniLit to those who receive “business as usual” classroom teaching or alternative RTI Tier 2 interventions. The current evidence for MiniLit consists of studies performed by the developer, including a small within-school, wait-list randomised controlled trial of the MiniLit program demonstrating its positive impact (5-8). Therefore, these promising findings now need to be evaluated in a large scale RCT to determine the impact of the program on student outcomes when scaled to system-level implementation. In addition, it is important to evaluate the process indicators that can predict the outcomes of the intervention, as well as the implementation cost-benefit.

The overarching question of this project is whether the MiniLit intervention, offered to Year 1 students identified as being in the bottom 25% of readers, improves student reading and literacy outcomes 12 months post-randomisation? 
The primary research aim of this project is:
1To determine, for Year 1 students in the bottom 25% of readers, whether students who receive MiniLit have better reading outcomes at 12 months post-randomisation, compared to those who have usual classroom teaching

We therefore hypothesise that students who receive the MiniLit intervention will have better mean reading ability scores on the Australian Edition of the York Assessment of Reading for Comprehension - Passage Reading (YARC – PR) at 12 months post-randomisation, compared to students who receive ‘business as usual’. 

The secondary aims are:
1. To determine student reading outcomes in both intervention and control groups 6 months (short term) post-randomisation.
2. To determine the proportion of students with ‘low reading ability’ in both intervention and control (‘business as usual’) groups at 6 and 12 months post-randomisation
3. To determine the implementation enablers and barriers that are predictive of program success and sustainability
4. To determine the cost per student, and cost-effectiveness of the intervention

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jon Quach

Address

Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010

Country

Australia

Phone

+61383441200

Fax

jon.quach@unimelb.edu.au

Contact person for public queries

Name

Jon Quach

Address

Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010

Country

Australia

Phone

+61383441200

Fax

jon.quach@unimelb.edu.au

Contact person for scientific queries

Name

Jon Quach

Address

Melbourne Graduate School of Education
The University of Melbourne
Level 4, 100 Leicester Street
Carlton, Victoria 3010

Country

Australia

Phone

+61383441200

Fax

jon.quach@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Testing of a synthetic phonics-based targeted reading intervention for students with reading difficulties in Year 1: Protocol for an efficacy randomised controlled trial.	2018	https://dx.doi.org/10.1136/bmjpo-2018-000301

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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