Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001935224
Ethics application status
Approved
Date submitted
26/11/2018
Date registered
28/11/2018
Date last updated
28/10/2019
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting mental health in children with dyslexia: Piloting the Clever Kids program
Scientific title
Piloting the Clever Kids program: An intervention to improve coping, emotion regulation, self-esteem, resilience, and mental health in children with dyslexia
Secondary ID [1] 296642 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslexia 310470 0
Condition category
Condition code
Mental Health 309304 309304 0 0
Learning disabilities
Neurological 309305 309305 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this pilot of the Clever Kids program will be children with a diagnosis of dyslexia who are in their final two years of primary school (Year 5 and Year 6). Participants will be recruited through the Dyslexia-SPELD Foundation (DSF), who will publicise the study in their regular newsletter, online forums, and via their email list.

The aim of this study is to determine the effectiveness and acceptability of the program in:

1) Developing effective coping and emotion regulation strategies
2) Improving self-esteem, resilience, and assertiveness in support-seeking
3) Reducing internalising and externalising symptomatology

The program is aimed at children with a diagnosis of dyslexia, implemented by a registered psychologist, and conducted in groups (n ~ 10). 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] 312952 0
Behaviour
Intervention code [2] 313026 0
Treatment: Other
Comparator / control treatment
Wait-list (no treatment) control. Participants will be randomised to either the Clever Kids or the Wait-list (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] 308158 0
Change in the use of Coping strategies (Adolescent Coping Scale)
Child-report
Timepoint [1] 308158 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Primary outcome [2] 308160 0
Change in Resilience (Connor-Davidson Resilience Scale)
Child-report
Timepoint [2] 308160 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Primary outcome [3] 308162 0
Change in the use of 2 Emotion Regulation strategies - cognitive reappraisal and expressive suppression (Emotion Regulation Questionnaire for Children and Adolescents)
Child-report
Timepoint [3] 308162 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Secondary outcome [1] 354104 0
Change in Self-esteem (Rosenberg Self-esteem Scale)
Child-report
Timepoint [1] 354104 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Secondary outcome [2] 354105 0
Change in Internalising and Externalising symptomatology (Strengths and Difficulties Questionnaire)
Child-report
Timepoint [2] 354105 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Secondary outcome [3] 354106 0
Change in Internalising and Externalising symptomatology (Strengths and Difficulties Questionnaire)
Parent-report (primary caregiver)
Timepoint [3] 354106 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention
Secondary outcome [4] 354456 0
Change in Frostig Success Attributes (Self-Awareness, Proactivity, Perseverance, Goal-setting, Support Systems, Coping Strategies). These six attributes will be assessed using a short questionnaire developed by the Dyslexia-SPELD Foundation. As this questionnaire has not yet been validated, this outcome is exploratory, and one of the aims of this pilot trial is to generate reliability and validity data for this measure.
Child-report
Timepoint [4] 354456 0
Baseline: Immediately pre-intervention
Follow-up: Immediately post-intervention
Maintenance: 3 months post intervention

Eligibility
Key inclusion criteria
Participants in the Clever Kids program are children with a diagnosis of dyslexia who are in their final two years of primary school (Year 5 and Year 6).

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. 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 medium-large intervention effects (f >= .25, power = .80, a = .05) on outcomes (G*Power 3.0.10; Faul, Erdfelder, Lang, & Buchner, 2007). General Linear Mixed Models (including participant as a random effect) will compare groups on the outcome measures across time. We will conduct both intention to treat and per protocol analyses. We hypothesize significant group*time interactions, with intervention effects at post-program assessment and maintained at three month follow-up.

Multiple mediation analyses using a bias-correcting bootstrapping procedure will be conducted to determine whether changes in coping, resilience, emotion regulation, and self-esteem mediate any effect of the intervention on internalising and externalising symptomatology. With n = 40 we will be powered to detect large effects (Fritz & MacKinnon, 2007).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2019
Actual
22/01/2019
Date of last participant enrolment
Anticipated
22/02/2019
Actual
20/02/2019
Date of last data collection
Anticipated
4/10/2019
Actual
3/10/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301221 0
Charities/Societies/Foundations
Name [1] 301221 0
Australian Rotary Health
Country [1] 301221 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA
6845
Country
Australia
Secondary sponsor category [1] 300855 0
None
Name [1] 300855 0
Address [1] 300855 0
Country [1] 300855 0
Other collaborator category [1] 280435 0
Charities/Societies/Foundations
Name [1] 280435 0
Dyslexia-SPELD Foundation
Address [1] 280435 0
10 Broome St
South Perth WA
6151
Country [1] 280435 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301965 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301965 0
Ethics committee country [1] 301965 0
Australia
Date submitted for ethics approval [1] 301965 0
Approval date [1] 301965 0
06/03/2018
Ethics approval number [1] 301965 0
HRE2018-0102

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

Contacts
Principal investigator
Name 88694 0
Dr Mark Boyes
Address 88694 0
School of Psychology
Curtin University
GPO Box U1987
Perth, WA
6845
Country 88694 0
Australia
Phone 88694 0
+61 8 9266 7025
Fax 88694 0
Email 88694 0
[email protected]
Contact person for public queries
Name 88695 0
Mark Boyes
Address 88695 0
School of Psychology
Curtin University
GPO Box U1987
Perth, WA
6845
Country 88695 0
Australia
Phone 88695 0
+61 8 9266 7025
Fax 88695 0
Email 88695 0
[email protected]
Contact person for scientific queries
Name 88696 0
Mark Boyes
Address 88696 0
School of Psychology
Curtin University
GPO Box U1987
Perth, WA
6845
Country 88696 0
Australia
Phone 88696 0
+61 8 9266 7025
Fax 88696 0
Email 88696 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
330Ethical approval    376409-(Uploaded-19-11-2018-14-07-15)-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.