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
ACTRN12623000371695
Ethics application status
Approved
Date submitted
23/03/2023
Date registered
13/04/2023
Date last updated
1/09/2024
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting mental health in children with dyslexia: Testing the Clever Kids program
Scientific title
Targeting coping strategies, emotional regulation and self-esteem in children with dyslexia: A randomised-controlled trial of the Clever Kids Program
Secondary ID [1] 309090 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12618001935224 was a pilot study of the same program to test feasibility of recruitment, and acceptability of the program.

Health condition
Health condition(s) or problem(s) studied:
Dyslexia 329210 0
Condition category
Condition code
Mental Health 326171 326171 0 0
Learning disabilities
Neurological 326172 326172 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have a diagnosed reading disability and will be in Year 5 and Year 6 (i.e., in the last two years of primary school or first year of high school). Participants will be recruited through the Dyslexia-SPELD Foundation and other clinical service providers, as well as via social media (facebook and twitter). Participants will be randomly allocated into either the intervention or wait-list control condition.

The aim of this study is to evaluate the effectiveness of the program in:
1) Developing effective coping and emotion regulation strategies
2) Improving self-esteem, perseverance/goal setting and assertiveness
3) Improving child mental health by reducing internalising and externalising symptomatology

The Clever Kids program is implemented by a registered psychologist and conducted in small groups (n~10). The program targets child self-esteem, assertiveness, perseverance coping, and emotion regulation strategies.

Group sessions are conducted once a week at DSF clinics. The program consists of nine weekly sessions attended after school over a school term. Each session lasts one hour and fifteen minutes. Session content has been informed by evidence-based socioemotional programs and adapted for children with reading difficulties.

The program concentrates intensively on three key skill areas: 1) awareness and strengthening of current coping methods, 2) challenging self-defeating thoughts, and 3) assertion skills to discover needs and ask appropriately for support.

Session 1 establishes group and confidentiality rules and considers the experience of dyslexia, with a specific focus on resilience and a multidimensional approach to self-esteem. Sessions 2-5 focus on coping, emotion regulation, and positive/optimistic thinking. Session 6 focuses on setting and pursuing achievable goals. Sessions 7 and 8 focus on developing assertive verbal and non-verbal behaviour. Session 9 revises and integrates program components. Sessions include the direct teaching of educational information by the psychologist, sharing and discussing individual experiences of living with dyslexia, small group work and games, goal-setting, and role-playing.

Adherence to the intervention will be assessed by monitoring attendance at each session.
Intervention code [1] 325569 0
Behaviour
Intervention code [2] 325570 0
Treatment: Other
Comparator / control treatment
Wait-list (no treatment) control. Participants will be randomised to either the Clever Kids or the waitlist (no treatment) condition. After the three-month post-program maintenance assessments are completed, children randomised to the Wait-list condition will have the opportunity to attend the program.
Control group
Active

Outcomes
Primary outcome [1] 334004 0
Change in the use of Coping strategies (Adolescent Coping Scale)
Child-report
Timepoint [1] 334004 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Primary outcome [2] 334005 0
Change in perceived difficulties regulating emotion (Difficulties in Emotion Regulation scale)
Child-report
Timepoint [2] 334005 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Primary outcome [3] 334006 0
Change in use of emotion regulation strategies (Emotion Regulation Questionnaire for Children and Adolescents)
Child report
Timepoint [3] 334006 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [1] 419184 0
Change in general self-esteem (Rosenberg Self-esteem Scale). This is an additional primary outcome.
Child report
Timepoint [1] 419184 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [2] 419185 0
Change in academic self-esteem (Self-Perception Profile for Children). This is an additional primary outcome
Child report
Timepoint [2] 419185 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [3] 419186 0
Change in social self-esteem (Self-Perception Profile for Children). This is an additional primary outcome.
Child report
Timepoint [3] 419186 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [4] 420387 0
Change in behavioural self-esteem (Self-Perception Profile for Children). This is an additional primary outcome.
Child-report
Timepoint [4] 420387 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [5] 420388 0
Change in perseverance (Grit Scale for Children and Adults). This is an additional primary outcome.
Child-report.
Timepoint [5] 420388 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [6] 420389 0
Change in assertiveness (Assertion sub-scale and two items from the body language scale – Social Skills Improvement System). This is an additional primary outcome.
Child report
Timepoint [6] 420389 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention (primary endpoint)
Maintenance: 3 months post completion of intervention
Secondary outcome [7] 420390 0
Change in internalising symptoms (Strengths and Difficulties Questionnaire).
Child report
Timepoint [7] 420390 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention
Maintenance: 3 months post completion of intervention
Secondary outcome [8] 420391 0
Change in internalising symptoms (Strengths and Difficulties Questionnaire).
Parent report
Timepoint [8] 420391 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention
Maintenance: 3 months post completion of intervention
Secondary outcome [9] 420392 0
Change in externalising symptoms (Strengths and Difficulties Questionnaire).
Child report
Timepoint [9] 420392 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention
Maintenance: 3 months post completion of intervention
Secondary outcome [10] 420393 0
Change in externalising symptoms (Strengths and Difficulties Questionnaire).
Parent report
Timepoint [10] 420393 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post completion of intervention
Maintenance: 3 months post completion of intervention
Secondary outcome [11] 420394 0
Acceptability of the program will be assessed using in-depth qualitative interviews with program attendees. The interviews will be semi-structured using a study specific protocol. The interviews will be conducted by trained research assistants under the supervision of the research team and will take approximately 30 minutes. All interviews will be audio recorded and transcribed verbatim.
Timepoint [11] 420394 0
Maintenance: 3 months post completion of intervention

Interviews will only be conducted after all quantitative data for the trial has been collected.
Secondary outcome [12] 421065 0
Change in anxiety symptoms (Revised Children's Anxiety and Depression Scale). Child report
Timepoint [12] 421065 0
Baseline: Immediately pre-intervention Follow-up: Immediately post completion of intervention Maintenance: 3 months post completion of intervention
Secondary outcome [13] 421066 0
Change in anxiety symptoms (Revised Children's Anxiety and Depression Scale). Parent report
Timepoint [13] 421066 0
Baseline: Immediately pre-intervention Follow-up: Immediately post completion of intervention Maintenance: 3 months post completion of intervention
Secondary outcome [14] 421067 0
Change in depression symptoms (Revised Children's Anxiety and Depression Scale). Child report
Timepoint [14] 421067 0
Baseline: Immediately pre-intervention Follow-up: Immediately post completion of intervention Maintenance: 3 months post completion of intervention
Secondary outcome [15] 421068 0
Change in depression symptoms (Revised Children's Anxiety and Depression Scale). Parent report
Timepoint [15] 421068 0
Baseline: Immediately pre-intervention Follow-up: Immediately post completion of intervention Maintenance: 3 months post completion of intervention

Eligibility
Key inclusion criteria
Participants in the Clever Kids program are children with a diagnosis of dyslexia who are in Year 5, Year 6, (i.e., in the last two years of primary school). Depending on the uptake, we may include Year 7, first year of high school.

One primary caregiver will need to be involved in the study. The primary caregiver will report on the child's emotional health, using the parent-report version of the Strengths and Difficulties Questionnaire and the Revised Children's Anxiety and Depression Scale. Participants must be willing to provide informed consent (parent consent and child assent).
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they are currently receiving psychological treatment or have additional complex needs. There are no exclusion criteria for parents.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule who will be "off-site" or at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a random number generator.
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
The study is powered to identify small-medium intervention effects (f >= .13, power = .80, a = .05) on mental health scores and hypothesised mechanisms of change. (G*Power 3.0.10; Faul, et al., 2007). Generalised Linear Mixed Models (controlling for potential random effects, e.g. gender) will compare groups on the outcome measures and mechanisms of change across time. We will conduct both intentions to treat and per protocol analyses. We hypothesise significant group*time interactions on all measures, with intervention effects at post-program assessment and maintained at 3-month follow-up. Mechanisms of change will be tested in multiple mediation analyses using 5000 bias-corrected bootstrapped resampling draws.

Descriptive statistics will summarise quantitative data and content analysis will be used for the open-ended questions collected in the short measures administered at the end of each programme session. Thematic Analysis (Braun & Clarke, 2008), a widely used qualitative analysis technique, will be used for identifying, investigating, interpreting, and reporting themes within the qualitative data set. Analyses will progress through the stages of gaining familiarity with the data, generating initial codes, identifying, and then reviewing themes, followed by defining and naming these.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/05/2023
Actual
8/05/2023
Date of last participant enrolment
Anticipated
19/04/2024
Actual
15/04/2024
Date of last data collection
Anticipated
20/09/2024
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313296 0
Government body
Name [1] 313296 0
National Health and Medical Research Council
Country [1] 313296 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA
6845
Country
Australia
Secondary sponsor category [1] 315065 0
None
Name [1] 315065 0
Address [1] 315065 0
Country [1] 315065 0
Other collaborator category [1] 282577 0
Charities/Societies/Foundations
Name [1] 282577 0
Dyslexia-SPELD Foundation
Address [1] 282577 0
10 Broome St
South Perth WA
6151
Country [1] 282577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312522 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 312522 0
GPO Box U1987
Perth, WA
6845
Ethics committee country [1] 312522 0
Australia
Date submitted for ethics approval [1] 312522 0
Approval date [1] 312522 0
30/01/2023
Ethics approval number [1] 312522 0
HRE2023-0034

Summary
Brief summary
Reading impairment (dyslexia) is the most common specific learning difficulty in Australia. Approximately 10% of Australian children have substantial difficulties in reading and spelling, and these children are at elevated risk of developing mental health problems: both internalising disorders (e.g. anxiety, depression) and externalising disorders (e.g. attention and conduct problems, delinquency). The transition from primary to secondary school is a particularly stressful period for children with dyslexia due to the increased educational demands and expectations placed on children regarding the quantity and quality of reading and writing. We will conduct a randomised controlled trial to evaluate the efficacy of a mental health promotion program (Clever Kids) in improving coping, emotion regulation, perseverance, assertiveness, and self-esteem, as well as both internalising and externalising symptoms for children with dyslexia in their final two years of primary school. We predict that program attendance will be associated with improvements in coping and emotion regulation skills, self-esteem, perseverance, assertiveness, as well as internalising and externalising symptoms. Additionally, we predict that these improvements will be maintained over the three month follow-up period. Acceptability of the program will be assessed using in-depth qualitative interviews with program attendees. The research will be conducted in partnership with the Dyslexia-SPELD Foundation (DSF).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124962 0
A/Prof Mark Boyes
Address 124962 0
Curtin University
GPO Box U1987
Perth, WA
6845
Country 124962 0
Australia
Phone 124962 0
+61 8 9266 7025
Fax 124962 0
Email 124962 0
[email protected]
Contact person for public queries
Name 124963 0
Mark Boyes
Address 124963 0
Curtin University
GPO Box U1987
Perth, WA
6845
Country 124963 0
Australia
Phone 124963 0
+61 8 9266 7025
Fax 124963 0
Email 124963 0
[email protected]
Contact person for scientific queries
Name 124964 0
Mark Boyes
Address 124964 0
Curtin University
GPO Box U1987
Perth, WA
6845
Country 124964 0
Australia
Phone 124964 0
+61 8 9266 7025
Fax 124964 0
Email 124964 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
Data sharing will need to be discussed with the community partner who is implementing the program.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18473Ethical approval    385476-(Uploaded-02-03-2023-19-00-54)-Study-related document.pdf



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.