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Trial registered on ANZCTR

Registration number

ACTRN12608000454370

Ethics application status

Approved

Date submitted

13/08/2008

Date registered

15/09/2008

Date last updated

8/10/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised control trial of treatments for children with different types of reading difficulty

Scientific title

The effect of phonics and sight-word reading treatment on the reading skills of children with different types of reading impairment

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Reading impairment

Dyslexia

Poor reading

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Mental Health

Learning disabilities

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The phonics treatment trained letter recognition, parsing, letter-sound rules, and blending. Sight-word treatment trained children to associate written irregular words (i.e., those that do not follow the letter-sound rules) with the appropriate pronunciations. These skills were trained using software programs. Children trained at home for 30 minutes per day, 5 days per week, for 8 weeks.

There were three treatment groups. Group 1 did no treatment (8 weeks) followed by phonics treatment (8 weeks) followed by sight-word treatment (8 weeks). Group 2 did no treatment (8 weeks) followed by sight-word treatment (8 weeks) followed by phonics treatment (8 weeks). Group 3 did no treatment (8 weeks) followed by a mix of phonics and sight-word treatment (8 weeks) followed by the same mix of phonics and sight-word treatment (8 weeks). Trainees rested for one week between 8-week training periods.

Intervention code [1]

Treatment: Other

Comparator / control treatment

This study used a double-baseline control. At the start of the study, each child in each group completed the outcomes measures (Time 1). After 8 weeks of *no* treatment, they redid the same tests (Time 2). We subtracted their scores at Time 1 from Time 2 to reveal "non-training" effects (e.g., test-retest effects, regression to the mean effects, maturation effects) on each test. In our analyses, we compared gains over each treatment periods to these non-training effects. Gains were only considered to be valid treatment effects if they were statistically significantly larger than the non-training effects.

Control group

Active

Outcomes

Primary outcome [1]

Castles and Coltheart 2 Nonword Reading Test

Timepoint [1]

At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).

Primary outcome [2]

Castles and Coltheart 2 Irregular-word Reading test

Timepoint [2]

Primary outcome [3]

The Test of Everyday Reading Comprehension (TERC)

Timepoint [3]

Secondary outcome [1]

Test of Word Reading Efficiency (TOWRE) Sight Word Efficiency and TOWRE Phonetic Decoding Efficiency

Timepoint [1]

Secondary outcome [2]

phonological recoding subskills (letter identification, parsing, letter-sound conversion, blending)

Timepoint [2]

Secondary outcome [3]

The Diagnostic Spelling Test for Nonwords (DiSTn) and the Diagnostic Spelling Test for Irregular Words (DiSTi)

Timepoint [3]

Eligibility

Key inclusion criteria

Children who have (1) English as their first language, (2) no problems with attention, hearing, sight, or behaviour, and (3) poor reading for their age.

Minimum age

7 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Poor attention, poor hearing, poor visual acuity, severe developmental delay

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)

Children with nonword or irregular word reading accuracy below the average range (i.e., below the 16th percentile) were allocated to Group 1, 2, or 3 using a quasi-randomised procedure based on time of enrolment (i.e., months 1 to 6 for Group 1, months 7 to 12 for Group 2 , and months 13 to 18 for Group 3).

If a child was deemed eligible for the study, the lead research assistant would allocate them to the appropriate group, which was stored in a centralised database. Subsequent testing of each child was done by another research assistants who were unaware of group allocation. No child was tested twice by the same research assistant.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Children were allocated to Group 1, 2, or 3 using a quasi-randomised procedure based on time of enrolment (i.e., months 1 to 6 for Group 1, months 7 to 12 for Group 2 , and months 13 to 18 for Group 3).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

To determine if there was a reliable difference between 8 weeks of phonics and sight word training, we used a between-group ANCOVA (controlling for each group’s corresponding non-training gains) to compare Time 1-Time 3 gains for each group. To determine if different orders of training had different effects on each outcome, we used a between-groups ANCOVA (controlling for non-training gains) to compare Time 1-Time 4 gains for each group.

Size of groups was determined based on outcomes of previous group studies of case studies suggesting that phonics training would have large effects on reading skills that depended heavily on phonics skills (d =0.8) and sight word training would have large effects on reading skills that depended on recognising whole words from memory (d = 0.8). With a power of 0.8, this equates to at least 26 children per group.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2008

Actual

1/10/2008

Date of last participant enrolment

Anticipated

Actual

31/12/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

104

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2000

Recruitment postcode(s) [2]

2010

Recruitment postcode(s) [3]

2020

Recruitment postcode(s) [4]

2030

Recruitment postcode(s) [5]

2040

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 5, 20 Allara Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Department of Cognitive Science
Macquarie University NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Ethics Secretariat

Ethics committee address [1]

Ethics Secretariat
Macquarie University NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/12/2007

Approval date [1]

11/12/2007

Ethics approval number [1]

HE28SEP2007-R05411

Summary

Brief summary

This study tested potential treatments for Australian children who have severe problems learning to read. Some of poor readers find it hard to read via the letter-sound rules (phonics), some find it hard to read whole words by sight (sight-word reading), and many have both of these problems.

In this study, one group of poor readers (N = 36) did 8 weeks of phonics training and then 8 weeks of sight word training; one group did the reverse (N = 36); and one group did phonics and sight word training simultaneously for two 8-week periods (N = 32). Sight word training lead to significant gains in sight word reading measures that were larger than gains made from phonics training; phonics training lead to statistically significant gains in a phonics reading measure that were larger than gains made from sight word training; and both types of training lead to significant gains in general reading that were similar in size. Training phonics before sight words had a slight advantage over the reverse order.

These findings demonstrate the reliability of both phonics and sight word training in treating poor readers. This will aid Australia’s efforts to counteract the effects of poor reading in children by revealing how different treatments should be tailored to children with different types of reading impairment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Genevieve McArthur

Address

Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9162

Fax

[email protected]

Contact person for public queries

Name

Genevieve McArthur

Address

Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9162

Fax

+61 2 9850 6059

[email protected]

Contact person for scientific queries

Name

Dr Genevieve McArthur

Address

Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109

Country

Australia

Phone

+61 2 9850 9162

Fax

+61 2 9850 6059

[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

Source	Title	Year of Publication	DOI
Embase	Replicability of sight word training and phonics training in poor readers: A randomised controlled trial.	2015	https://dx.doi.org/10.7717/peerj.922

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

Trial Review

Documents added manually

Documents added automatically