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Trial registered on ANZCTR


Registration number
ACTRN12615000415505
Ethics application status
Approved
Date submitted
27/03/2015
Date registered
1/05/2015
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of inferential comprehension intervention for children with specific language impairment.
Scientific title
For pre-primary age children with specific language impairment, does an oral inferential comprehension programme lead to improved oral inferential comprehension skills compared to a control phonological awareness treatment.
Secondary ID [1] 286427 0
Nil
Universal Trial Number (UTN)
U1111-1168-7660
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific Language Impairment 294596 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294898 294898 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be randomly allocated to one of two intervention groups (the oral inferential comprehension (OIC) intervention or the comparison intervention targeting phonological awareness (PA)). The participants will then take part in the intervention, implemented by the researcher.
The intervention will run over an 8 week period during Term 3, 2015, from Week 2 to Week 9. During this time, the intervention will be provided to each group of four children two times per week, for sessions of approximately 30 minutes. The interventions will be run by the researcher (a qualified speech pathologist) and will be included as a part of the weekly classroom activities for the participants involved.
The OIC intervention sessions will focus on the explicit instruction and practice of narrative macrostructure (drawing on components of a commercial programme: Braidy the StoryBraid (Trademark) ) (Moreau & Zagula, 2002) and narrative microstructure concepts. The intervention has been designed based on the intervention principles pertaining to the large body of research in speech pathology journals regarding interventions for children with specific language impairment (e.g. duration and intensity of intervention sessions, appropriacy of intervention activities, etc). As such, the activities involved in the intervention will be appropriate for the age and the population and will be highly engaging and rewarding for the participants (e.g. small group interactive reading of storybooks, role-playing with puppets, etc).
Intervention code [1] 291504 0
Treatment: Other
Comparator / control treatment
The PA intervention will focus on the explicit instruction and practice of phonological awareness skills (such as rhyme, phoneme identity, segmentation and blending) based on the Gillon Phonological Awareness Training (PAT) Programme (Gillon, 2008).
Control group
Active

Outcomes
Primary outcome [1] 294653 0
Pre- and post treatment data collection will include measures of:
Inferential and literal comprehension of narrative using the Squirrel Story Narrative Assessment on iPad (Carey, Leitao, & Allan, 2006) which includes the Narrative Comprehension of Picture Books questions (NC task) (Paris & Paris, 2003).


Timepoint [1] 294653 0
Pre-treatment will be carried out in the week prior to intervention commencing and post-treatment will be carried out in the week following intervention.
Primary outcome [2] 294910 0
Pre- and post treatment data collection will include measures of:
Phonological awareness skills as measured by the Preschool and Primary Inventory of Phonological Awareness (PIPA) (Ozanne et al, 2000).
Timepoint [2] 294910 0
Pre-treatment will be carried out in the week prior to intervention commencing and post-treatment will be carried out in the week following intervention.
Secondary outcome [1] 313800 0
Nil
Timepoint [1] 313800 0
N/A

Eligibility
Key inclusion criteria
The participants in this study will be recruited from a Language Development Centre (LDC) in metropolitan Perth and therefore have a diagnosis of specific language impairment. Participants will be both male and female and will be in pre-primary (aged 4;6 to 5;6, years;months).
The study will recruit a minimum of 40 children as participants. In addition to their current enrolment in pre-primary at an LDC, participants will meet the following selection criteria:
1. English as a primary language (identified by parents on the consent form).
2. Intelligible speech at discourse level
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria = evidence of significant hearing, vision, behavioural, language and educational or medical issues.

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)
Central randomisation by computer will be used to allocate participants, once consent has been received, to two equally sized groups . Allocation will be determined by the Random Sequence Generator at www.random.org
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following consent, each participant will complete an initial assessment session (20-30 minutes, including breaks) with the researcher.

The participants then will be randomly allocated to one of two intervention groups (the inferential comprehension intervention or the comparison intervention targeting phonological awareness).

Randomisation to two equally sized groups will be determined by the Random Sequence Generator at www.random.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This research aims to evaluate the effectiveness of an intervention created to improve oral inferential comprehension (based on the findings of Study 1 which was a descriptive profiling study) in young children with specific language impairment. Study 2 will involve developing and piloting an intervention targeted at improving oral inferential comprehension in a small randomised controlled trial of children with specific language impairment. Participants will be randomly allocated to the oral inferential comprehension treatment (OIC) or the comparison phonological awareness treatment (PA) conditions.

There will be a significant Group x Condition interaction between T1 and T3 such that:
Hypothesis 2a: Compared to the PA control group, the OIC intervention group will show significantly greater T1 to T2 increase in oral inferential comprehension scores.
Hypothesis 2b: The intervention group’s T1 to T2 increase in oral inferential
comprehension scores will be maintained at T3.
Hypothesis 3a: The proportion of individuals showing a positive reliable
change in oral inferential comprehension score between T1 and T2 will be significantly greater for the OIC intervention group.
Hypotheses 2a – 2b will be tested using a Generalised Linear Mixed Model (GLMM). The GLMM will be implemented through SPSS’s (Version 22) GENLINMIXED procedure. The GLMM will include one nominal random effect (participant), one categorical fixed effect (group: intervention versus control), one ordinal fixed effect (time: T1 – T3), and the Group x Time interaction. Violations of sphericity (associated with multiple assessments of the same individuals) will be accommodated by changing the covariance matrix from the default of compound symmetry to autoregressive. Twenty participants in each of the two groups should provide an 80% chance of capturing ‘moderate’ (f = .19) intervention effects at an alpha-level of .05.
Hypothesis 3a will be tested by computing a T1-T2 reliable change (RC) score for each participant on the outcome measures. The RC score is the degree to which the participant changes on the outcome variable (oral inferential comprehension score) divided by the standard error of difference between the T1 and T2 scores (Jacobson & Truax, 1991). When the absolute value of the RC score is greater than 1.96, it is likely that the post-test score reflects a real or reliable change. It has been argued that this value can be reduced in some situations (Wise, 2004). The proportion of individuals showing a reliable T1-T2 change in the intervention group will be compared to the proportion of individuals showing such a change in the control group. The statistical significance of the comparison will be estimated with a binary logistic GLMM model which will include the fixed nominal predictor (group: intervention, control) and the binary outcome (reliable change: yes, no). Computation of the RC score for a particular outcome will require estimates of the outcome’s reliability and variability for a population of individuals similar to the target population sampled. The Cronbach’s alpha and standard deviation from Study 1 will be used as an estimate of reliability and variability. These analyses will be used to address the third research question.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2015
Actual
25/05/2015
Date of last participant enrolment
Anticipated
Actual
3/07/2015
Date of last data collection
Anticipated
Actual
20/11/2015
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290998 0
University
Name [1] 290998 0
Curtin University
Country [1] 290998 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
Perth
WA
6845
Country
Australia
Secondary sponsor category [1] 289676 0
None
Name [1] 289676 0
Address [1] 289676 0
Country [1] 289676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292584 0
Curtin University HREC
Ethics committee address [1] 292584 0
Ethics committee country [1] 292584 0
Australia
Date submitted for ethics approval [1] 292584 0
30/03/2015
Approval date [1] 292584 0
28/04/2015
Ethics approval number [1] 292584 0

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

Contacts
Principal investigator
Name 56094 0
Dr Suze Leitao
Address 56094 0
School of Psychology & Speech Pathology
Curtin University GPO Box U1987
Perth WA 6845
Country 56094 0
Australia
Phone 56094 0
+ 61 8 9266 7620
Fax 56094 0
Email 56094 0
S.Leitao@Curtin.edu.au
Contact person for public queries
Name 56095 0
Suze Leitao
Address 56095 0
School of Psychology & Speech Pathology
Curtin University GPO Box U1987
Perth WA 6845
Country 56095 0
Australia
Phone 56095 0
+ 61 8 9266 7620
Fax 56095 0
Email 56095 0
S.Leitao@Curtin.edu.au
Contact person for scientific queries
Name 56096 0
Suze Leitao
Address 56096 0
School of Psychology & Speech Pathology
Curtin University GPO Box U1987
Perth WA 6845
Country 56096 0
Australia
Phone 56096 0
+ 61 8 9266 7620
Fax 56096 0
Email 56096 0
S.Leitao@Curtin.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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