Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000159853
Ethics application status
Approved
Date submitted
6/11/2020
Date registered
16/02/2021
Date last updated
16/02/2021
Date data sharing statement initially provided
16/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
eHealth for mental health in DCD: Can a family-based eHealth program improve mental health in Developmental Coordination Disorder?
Scientific title
eHealth for mental health in DCD: Can a family-based eHealth program improve anxiety and depression in Developmental Coordination Disorder?
Secondary ID [1] 302705 0
None
Universal Trial Number (UTN)
U1111-1260-8209
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Coordination Disorder 319640 0
Condition category
Condition code
Mental Health 317580 317580 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will undertake a 12-week program, from their own homes, which will require them to:
1) Enrol in an invitation-only, private Facebook group.
2) Agree to both one parent, and their child with DCD, wearing an activity tracking watch each day.
3) Agree to sync the watches to the appropriate, nominated smart phone applications each day.
4) Complete baseline questionnaires.
5) Complete a weekly data log using the smart phone application to record PA levels.
6) Complete a weekly physical activity questionnaire.
7) At monthly intervals, complete the Strengths and Difficulties Questionnaire, SWAN Rating Scale for ADHD, and Pediatric Quality of Life Inventory.
8) The measures in (7) will also be completed at 1- and 3-month post-intervention time points.

Weekly physical activity logs and questionnaire will take approximately 20 mins to complete; the monthly questionnaire pack will require an additional 30-45 minutes to complete.

The intervention will utilise a dual method (website + invitation only Facebook group) of online education and engagement. A static website will be used to host educational materials and videos, which will take approximately 30-60 mins to review each week. The initial information hosted on the website will be educational material concerning the impact of DCD and the benefit of PA on mental health. Each week of the intervention, new information, based around a set theme for the week, will be uploaded. The weekly topics will be finalised following the focus group analysis and the resources produced will be created in line with the principles of self-determination theory (SDT) and the behaviour change framework of Michie et al. [2011]. According to this theory, intrinsic motivation is a key determinate of physical activity engagement, linked to high levels of autonomy, competence and relatedness [Deci & Ryan, 1985]. Additionally, another form of motivation identified by SDT, identified regulation, has been recognised as a key factor in motivating parents to increase their own, and their families, physical activity levels [e.g. Emm-Collison et al., 2019; Solomon-Moore et al., 2017]. Based on this, the resources produced will aim to educate families to increase both their own, and their child’s, sense of autonomy, competence and feelings of relatedness in regard to physical activity (intrinsic motivation), while also providing education around the benefits of physical activity on mental health, to increase the value and importance of physical activity (identified regulation).

Resources will include short, informative videos, slide shows, blogs and links to further information. These resources will be promoted actively via the invitation-only Facebook group, which all participating parents will be required to join. The study Facebook group will be moderated by a research assistant. They will be tasked with linking and reinforcing information from the static website to the group, as well as using evidence-based behaviour change techniques to provide further instructions on goal setting and monitoring, general encouragement, address barriers and facilitate discussion boards for information sharing and social support. Participants will receive digital badges as ‘rewards’ for meeting goals, consistency, engagement etc. [Ola et al., 2020; Schoenfelder, et al., 2017; Mendoza et al., 2017]. This group will also serve as a way to remind participants to complete surveys as required and sync/maintain their activity tracker. The latter will allow researchers to access information regarding daily step counts and active minutes. Facebook engagement will be recorded weekly using the number of participant 'likes', comments, views and posts within the group page.

Parents failing to complete the weekly and/or monthly questionnaires will receive reminders via email and/or text message at 24 and 48 hours and a final reminder will be sent after 72 hours.

The intervention will be run by a research assistant with a minimum qualification of a Masters degree in Psychology, overseen by the research team, which includes four clinical psychologists and one psychiatrist.
Intervention code [1] 319003 0
Behaviour
Intervention code [2] 319004 0
Lifestyle
Comparator / control treatment
Participants in the control group will be required to commit to items 1-7 listed under the intervention. The differences in their Facebook group will be described below. The participants in the control group will not undergo a 1- and 3-month follow-up as they will instead be provided with the opportunity to, at the completion of their three months, enrol in a subsequent 12-week intervention that will provide them with the full resources and support offered previously to the intervention group.
In the first 12 weeks, participants in the control group will be provided with access to the initial education material contained on the static website, but will not be able to access the weekly educational packages and the Facebook group will only be used to post generic information and reminders about wearing and syncing the trackers, and completing questionnaires. At the completion of the 12-week period, members of the control group will be given the opportunity to participate in a second 12-week intervention, during which they would receive the above described intervention.
Control group
Active

Outcomes
Primary outcome [1] 325625 0
Physical activity levels, as measured via the wrist-worn activity tracker of the participating parent and child, along with the Children's Physical Activity Questionnaire (C-PAQ).
Timepoint [1] 325625 0
Activity trackers will be synced to an app daily; parents will use the stats provided in the app to complete a weekly log throughout the 12 week period.
C-PAQ will be completed at baseline, weekly throughout the intervention, and then at 1- and 3-month follow-up points.
Primary outcome [2] 325626 0
Mental health will be measured using the internalising and externalising subscales of the Strengths and Difficulties Questionnaire.
Timepoint [2] 325626 0
Completed at baseline, monthly throughout the intervention, and at 1- and 3-month follow-up points post-intervention.
Primary outcome [3] 325627 0
Quality of life, assessed using the PedsQL.
Timepoint [3] 325627 0
Completed at baseline, monthly throughout the intervention, and at 1- and 3-month follow-up points post-intervention.
Secondary outcome [1] 388596 0
ADHD-related symptoms, measured using the SWAN rating scale.
Timepoint [1] 388596 0
Completed at baseline, monthly throughout the intervention, and at 1- and 3-month follow-up points post-intervention.

Eligibility
Key inclusion criteria
Parent or carer (aged 18+) of a child, aged 5-10 years, who has a diagnosis of Developmental Coordination Disorder or Dyspraxia.
Families need to be based in Australia, will need to be fluent English speakers, and have access to a Facebook account. They need to consent to join an invitation-only, closed Facebook account and agree to the various points outlined in the procedure around wearing the physical activity trackers and syncing these to the prescribed applications.
Children with co-occurring developmental disorders will not be excluded, but if on medication for co-occurring disorders, a stable medication regime will be required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intellectual disability, in either child or parent/carer; non-English speaker; parent/carer or child has a physical disability (not including DCD) that would impact on their ability to undertake physical activity; parent/carer or child has a medical condition that would impact their ability to undertake physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is determined using sequence generation as specified below. Allocation will be conducted by the study Chief Investigator AFTER the study Research Assistant has determined if a family unit is eligible to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, stratified by the gender of the child within the family unit.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The initial stage of this trial is a parallel design. However, those in the control group will be able to participate in a crossover phase if they choose to, where they will also be eligible to receive the active intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous interventions have not been conducted with parents/families as the primary recipient of the intervention, with the exception of the small ADHD pilot study (Ola et al., 2020) – however, this was to test the parent satisfaction with the intervention, rather than the impact of the intervention itself, and is thus not suitable for power analysis. Sample size calculation was therefore based on a recent paper that modelled sample sizes required for pilot randomised trials with a continuous outcome variable (Whitehead et al., 2016). In this case, a sample size of 25 per treatment arm is required when a small (0.2) effect size is expected and 15 per treatment arm for a medium (0.5) effect size. The current trial errs on the side of caution, powering with the expectation of a small effect.

All questionnaire data will be scored and converted into continuous numeric variables. Generalised linear mixed models will be used to estimate the effect of the intervention on our independent variables (steps; active minutes; and scores on the C-PAQ, SDQ, SWAN and PedsQL questionnaires). Repeated measures will be accounted for by including a random effect, and group, time and group x time interactions will be included as fixed effects. The model will be adjusted for sex, DCD symptom severity and activity monitor wear time, as well as parental scores on the BREQ-3 if required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2021
Actual
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307139 0
Charities/Societies/Foundations
Name [1] 307139 0
Waterloo Foundation
Country [1] 307139 0
United Kingdom
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428
Melbourne
VIC 8001
Australia
Country
Australia
Secondary sponsor category [1] 307722 0
None
Name [1] 307722 0
Address [1] 307722 0
Country [1] 307722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307251 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 307251 0
Ethics committee country [1] 307251 0
Australia
Date submitted for ethics approval [1] 307251 0
23/09/2020
Approval date [1] 307251 0
18/11/2020
Ethics approval number [1] 307251 0
HRE20-175

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

Contacts
Principal investigator
Name 106570 0
A/Prof Jacqueline Williams
Address 106570 0
Institute for Sport and Health
Victoria University
PO Box 14428
Melbourne, VIC 8001, Australia
Country 106570 0
Australia
Phone 106570 0
+61 399194025
Fax 106570 0
Email 106570 0
[email protected]
Contact person for public queries
Name 106571 0
Jacqueline Williams
Address 106571 0
Institute for Sport and Health
Victoria University
PO Box 14428
Melbourne, VIC 8001, Australia
Country 106571 0
Australia
Phone 106571 0
+61 399194025
Fax 106571 0
Email 106571 0
[email protected]
Contact person for scientific queries
Name 106572 0
Jacqueline Williams
Address 106572 0
Institute for Sport and Health
Victoria University
PO Box 14428
Melbourne, VIC 8001, Australia
Country 106572 0
Australia
Phone 106572 0
+61 399194025
Fax 106572 0
Email 106572 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
No ethical approval to do so - only to report on group data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9653Study protocol  [email protected]



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.