Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000275561
Ethics application status
Approved
Date submitted
4/03/2015
Date registered
24/03/2015
Date last updated
16/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Active minds, happy kids: a family-based online intervention focusing on electronic media use
Scientific title
Active minds, happy kids: can a family-based, online intervention decrease electronic media use in preschool children
Secondary ID [1] 286270 0
Nil
Universal Trial Number (UTN)
U1111-1167-8848
Trial acronym
AMHK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screen-based entertainment (SBE)
294335 0
Sedentary behaviour 294377 0
Social skills 294378 0
Cognitive functioning 294379 0
Condition category
Condition code
Public Health 294651 294651 0 0
Health promotion/education
Mental Health 294804 294804 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project builds on a previously trialled feasibility study, Family@play. That project was a six-week, group-based trial which delivered the program to 20 families with 2-3 year old children. Family@play was effective at decreasing children’s overall electronic media use. Active minds, happy kids will deliver similar content to 80 families with 3-5 year old children. Active minds, happy kids will employ online technologies to deliver content and promote interaction between study participants.

This is an eight week intervention with pre- and post-intervention assessments. Participants will be families with a child aged 3-5 years who has not yet started school. Group sessions will take place at the preschools through which families were recruited.

The intervention consists of one 90 minute group-based session, 3 x 10-15 min modules online each week for 7 weeks and associated online activities. An intervention using groups with a common affiliation (i.e. their children attend the same preschool) is effective for behavioural intervention delivery. This program is theoretically informed and draws on constructs from the Social Cognitive (SCT) and Family Systems (FST) theories.

Content will focus on three primary components: a) non-selectively decreasing electronic media use (budgeting, removing electronic media); b) selectively reducing use (rules, limiting participation); and c) displacing use with other activities (reading, imaginary games). Content for group sessions will include: changing and influencing children’s behaviours; health and developmental implications of electronic media; building motivation and skills to change behaviours (self-monitoring, goal setting); self-efficacy (identify barriers, goal setting); and relapse prevention. Strategies will focus on activities aimed to support children’s social skills and cognitive functioning while encouraging lower levels of electronic media use. Group sessions will also discuss the online activities and will use an anticipatory guidance perspective to facilitate group-based problem solving of possible challenges. Online activities will provide opportunity for within-group peer interaction to facilitate sharing of ideas, experiences and strategies.

Strategies to monitor adherence include; attendance at group session, website generated reports of access to web-based materials, monitoring and recording of interactions on Facebook group.
Intervention code [1] 291289 0
Behaviour
Intervention code [2] 291290 0
Prevention
Intervention code [3] 291292 0
Lifestyle
Comparator / control treatment
This study is a pilot group randomised trial with a wait-list control group, involving an eight week intervention and pre- and post-intervention assessments. Those in the control group will have the opportunity to participate in the intervention once follow-up data is collected. Control group participants will receive all content online immediately after the post-intervention assessments
Control group
Active

Outcomes
Primary outcome [1] 294446 0
Change in electronic media use by children participating in the program. Outcome assessed using parent-report of child usual weekly time in electronic media use
Timepoint [1] 294446 0
End of intervention (8 weeks)
Primary outcome [2] 294447 0
Change in time spent in sedentary behaviour using ActiGraph accelerometer (intenationally recognised and used activity monitor) on participating children that will be fitted around the waist of the child to assess activity levels for one week.
Timepoint [2] 294447 0
End of intervention (8 weeks)
Secondary outcome [1] 313339 0
Change in child social skill pre- to post-intervention. Outcome assessed by parent report of child social skills using the Social Skills Inventory System.
Timepoint [1] 313339 0
End of intervention (8 weeks)
Secondary outcome [2] 313340 0
Changes in child cognitive functioning pre- to post-intervention. Children’s cognitive functioning, such as language skills and executive functioning, will be assessed using the NEPSY-II. The test is suitable for children aged 3-years and older. The assessment will also involve using an eye-tracker to measure children’s eye-movements as they look at different pictures. The eye-tracker sits in front of the children. A headrest is not required for this instrument
Timepoint [2] 313340 0
End of intervention (8 weeks)

Eligibility
Key inclusion criteria
Participating families will have one child aged between 3 and 5 years who attends preschool at one of the randomly selected preschools. Participating parents will be willing, able and available to attend the group session when scheduled, and be willing to be randomised into either the intervention or control group.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria

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)
Participants in this intervention will be 80, three- through five-year-old children and their parents. Participants will be recruited through 16 preschools and kindergarten groups. Once baseline measures are complete, families at 8 of the 16 preschools will be randomly selected to receive the treatment from May through June/July 2015. A computer generated program will be used to randomly assign the groups to either intervention or control conditions. The control group will receive the program once all measures (post-intervention, follow-up) are completed.

The allocation will be concealed as it will be done by central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed following baseline measurements to minimise withdrawal. Participant groups will be randomised using a computer-based random number-producing algorithm to either the intervention group (40 participant families; 8 centres) or the wait list control group (40 participant families; 8 centres). To prevent allocation bias, staff taking measurements, will be kept blind to the allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Wait list control - both control and intervention groups will receive the intervention; controls will receive the intervention once all data has been collected (post-intervention, follow-up) and no further data will be collected once they have participated in the program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative and quantitative process analyses

Potential efficacy will be assessed using linear mixed models for each of the primary and secondary outcomes.

Eighty families across 16 groups will be recruited and randomised to either a wait-list control (n=40) or intervention (n=40) group. Previous experience of the research team suggests that this recruitment target is feasible within the two month period allocated. The study has 80% power to detect a standardised mean difference of 0.64 on a single comparison of means. This corresponds to a medium effect size according to Cohen’s taxonomy. Families with a child aged 3-5 years attending one of the selected preschools, and a parent who speaks, reads and writes fluent English and is able to attend the group face-to-face sessions are eligible to participate. Families will be screened prior to participation to assess their child’s electronic media use. Those families with a child who exceeds the Australian recommendation of one hour per day will be eligible for participation in this study. Our previous research suggests this will be about 80% of families.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2015
Actual
17/04/2015
Date of last participant enrolment
Anticipated
29/05/2015
Actual
29/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9299 0
3147 - Ashburton
Recruitment postcode(s) [2] 9300 0
3103 - Balwyn
Recruitment postcode(s) [3] 9301 0
3104 - Balwyn North
Recruitment postcode(s) [4] 9302 0
3130 - Blackburn
Recruitment postcode(s) [5] 9303 0
3130 - Blackburn North
Recruitment postcode(s) [6] 9304 0
3130 - Blackburn South
Recruitment postcode(s) [7] 9305 0
3128 - Box Hill
Recruitment postcode(s) [8] 9306 0
3125 - Burwood
Recruitment postcode(s) [9] 9307 0
3151 - Burwood East
Recruitment postcode(s) [10] 9308 0
3124 - Camberwell
Recruitment postcode(s) [11] 9309 0
3126 - Canterbury
Recruitment postcode(s) [12] 9310 0
3131 - Forest Hill
Recruitment postcode(s) [13] 9311 0
3146 - Glen Iris
Recruitment postcode(s) [14] 9312 0
3122 - Hawthorn
Recruitment postcode(s) [15] 9313 0
3123 - Hawthorn East
Recruitment postcode(s) [16] 9314 0
3101 - Kew
Recruitment postcode(s) [17] 9315 0
3102 - Kew East
Recruitment postcode(s) [18] 9316 0
3144 - Malvern
Recruitment postcode(s) [19] 9317 0
3132 - Mitcham
Recruitment postcode(s) [20] 9318 0
3129 - Mont Albert North
Recruitment postcode(s) [21] 9319 0
3149 - Mount Waverley
Recruitment postcode(s) [22] 9320 0
3131 - Nunawading
Recruitment postcode(s) [23] 9321 0
3127 - Surrey Hills
Recruitment postcode(s) [24] 9322 0
3133 - Vermont
Recruitment postcode(s) [25] 9323 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 290827 0
University
Name [1] 290827 0
Deakin University
Country [1] 290827 0
Australia
Primary sponsor type
Individual
Name
Trina Hinkley
Address
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 289514 0
Individual
Name [1] 289514 0
Dr Jarrad Lum
Address [1] 289514 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [1] 289514 0
Australia
Secondary sponsor category [2] 289515 0
Individual
Name [2] 289515 0
Dr Dylan Cliff
Address [2] 289515 0
University of Wollongong
Northfields Ave
Wollongong
NSW, 2522
Country [2] 289515 0
Australia
Secondary sponsor category [3] 289516 0
Individual
Name [3] 289516 0
Dr Kylie Hesketh
Address [3] 289516 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [3] 289516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292448 0
Human Ethics Advisory Group
Ethics committee address [1] 292448 0
Ethics committee country [1] 292448 0
Australia
Date submitted for ethics approval [1] 292448 0
17/12/2014
Approval date [1] 292448 0
19/01/2015
Ethics approval number [1] 292448 0
HEAG-H 202_2014
Ethics committee name [2] 292449 0
Department of Education and Training - Research, evaluation and analytics branch
Ethics committee address [2] 292449 0
Ethics committee country [2] 292449 0
Australia
Date submitted for ethics approval [2] 292449 0
13/01/2015
Approval date [2] 292449 0
24/02/2015
Ethics approval number [2] 292449 0

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

Contacts
Principal investigator
Name 55342 0
Dr Trina Hinkley
Address 55342 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 55342 0
Australia
Phone 55342 0
+61 3 9244 5480
Fax 55342 0
Email 55342 0
[email protected]
Contact person for public queries
Name 55343 0
Trina Hinkley
Address 55343 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 55343 0
Australia
Phone 55343 0
+61 3 9244 5480
Fax 55343 0
Email 55343 0
[email protected]
Contact person for scientific queries
Name 55344 0
Trina Hinkley
Address 55344 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 55344 0
Australia
Phone 55344 0
+61 3 9244 5480
Fax 55344 0
Email 55344 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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