Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001822279
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
9/11/2018
Date last updated
25/03/2021
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Physical Activity Program in School-Aged Children with Attention Deficit Hyperactivity Disorder.
Scientific title
The Effect on Behaviours with Group-Based Exercise in School-Aged Children with Attention Deficit Hyperactivity Disorder
Secondary ID [1] 295517 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder 308781 0
Condition category
Condition code
Mental Health 307717 307717 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise group: Participants in the exercise group will attend a cricket training program at community cricket clubs for that each week will have one session from 75 to 90 minutes to learn how to play cricket. The handbook for Cricket Blast (https://playcricket.com.au/junior/cricketblast- juniorblasters/resource-hub) will be used as the standard guide for the cricket clubs and participants.

Waitlist group: Participants will wait for eight weeks and one month after baseline and pre-intervention measurements until the follow-up measurement. Then they could choose to participate in the same cricket program at community cricket clubs.
Intervention code [1] 301830 0
Lifestyle
Intervention code [2] 301831 0
Behaviour
Comparator / control treatment
Waitlist control
Control group
Active

Outcomes
Primary outcome [1] 306702 0
The severity of ADHD symptoms measured by the Brief Problems Monitor-Parent Form (BPM-P)
Timepoint [1] 306702 0
T1: At Baseline (before the program starts)
T2: Post-intervention (primary endpoint)
T3: One-month follow up
Primary outcome [2] 306703 0
Executive functions measured by a computerised Stroop color test
Timepoint [2] 306703 0
T1: At Baseline (before the program starts)
T2: Post-intervention (primary endpoint)
T3: One-month follow up
Primary outcome [3] 306704 0
The objective measure for the whole day of daily activity measured by an Actigraph (GT3X), which is to be worn on the waist for 7 days
Timepoint [3] 306704 0
T1: At Baseline (before the program starts)
T2: Post-intervention (primary endpoint)
T3: One-month follow up
Secondary outcome [1] 349303 0
Weekly physical activity measured by the Children's Leisure Activities Study Survey- Parent Questionnaire, CLASS (Telford, 2004)
Timepoint [1] 349303 0
T1: At Baseline (before the program starts)
T2: Post-intervention (intervention period ends)
T3: One-month follow up
Secondary outcome [2] 349304 0
Sleep quality in children measured by the Children’s Sleep Habits Questionnaire, CSHQ
Timepoint [2] 349304 0
T1: At Baseline (before the program starts)
T2: Post-intervention (intervention period ends)
T3: One-month follow up
Secondary outcome [3] 349305 0
Self-report Daily Activity Dairy for seven days.
Timepoint [3] 349305 0
T1: At Baseline (before the program starts)
T2: Post-intervention (intervention period ends)
T3: One-month follow up
Secondary outcome [4] 352730 0
The objective measure for the sleep quality measured by an Actigraph (GT3X), which is to be worn on the waist for 7 days
Timepoint [4] 352730 0
T1: At Baseline (before the program starts)
T2: Post-intervention (intervention period ends)
T3: One-month follow up

Eligibility
Key inclusion criteria
1. Aged 8-12 years;
2. Fluent in English with no translation service required;
3. Consent to participate in the study;
4. Diagnosis of ADHD
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children with a current history of intellectual disability, that is an intelligence quotient below 70. This will be determined by self-report using the screening question: "Has your child been formally diagnosed by a mental health practitioner (e.g., psychologist or psychiatrist) as having an intellectual disability?"
2. Children with a past history of seizures. This will be determined by self-report using the screening question: "Has your child experienced any seizures during the past year?"

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)
All participants will be randomly allocated to exercise or education groups after signing the consent form. The participant numbers will be assigned to either group using a computerized randomization program (randomization.com) at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2018
Actual
30/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300099 0
University
Name [1] 300099 0
RMIT University
Country [1] 300099 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Cricket Australia
Address
128 Jolimont Rd, Jolimont Victoria 3002
Country
Australia
Secondary sponsor category [1] 300434 0
None
Name [1] 300434 0
Address [1] 300434 0
Country [1] 300434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300944 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 300944 0
GPO Box 2476, RMIT Building 91, Level 2, MELBOURNE VIC, 3001
Ethics committee country [1] 300944 0
Australia
Date submitted for ethics approval [1] 300944 0
30/08/2018
Approval date [1] 300944 0
05/10/2018
Ethics approval number [1] 300944 0

Summary
Brief summary
An exercise intervention will engage 40 children with Attention deficit hyperactivity disorder (ADHD) in 8-12 years of age. The intervention group children will participate in an 8-week cricket program whereas the wait list group will do so after the three-time measurements on symptoms and life style patterns regarding sleep, physical activity, and screen time. We hypothesise the physical activity of a cricket program will significantly improve the participating children’s symptom and life style when compared with the wait list group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85366 0
Dr Eunro Lee
Address 85366 0
School of Health of Biomedical Science, Plenty Rd, 201.3.14B Bundoora campus, RMIT University, VIC, 3083
Country 85366 0
Australia
Phone 85366 0
+61 3 9925 7610
Fax 85366 0
Email 85366 0
[email protected]
Contact person for public queries
Name 85367 0
Mr George Hong
Address 85367 0
School of Health of Biomedical Science, Plenty Rd, Building 214, Level 1, RMIT University, VIC, 3083
Country 85367 0
Australia
Phone 85367 0
+61 3 9925 7612
Fax 85367 0
Email 85367 0
[email protected]
Contact person for scientific queries
Name 85368 0
Dr Eunro Lee
Address 85368 0
School of Health of Biomedical Science, Plenty Rd, 201.3.14B Bundoora campus, RMIT University, VIC, 3083
Country 85368 0
Australia
Phone 85368 0
+61 3 9925 7610
Fax 85368 0
Email 85368 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
We will not make individual participant data publicly available since our participants will be children. Highly confidential to any data to each participant is necessary.


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
No additional documents have been identified.