Trial Review

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
ACTRN12620000980932
Ethics application status
Approved
Date submitted
24/06/2020
Date registered
30/09/2020
Date last updated
28/11/2022
Date data sharing statement initially provided
30/09/2020
Date results information initially provided
28/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of digital parenting interventions on parent confidence and child behaviour in New Zealand.
Scientific title
App based parenting interventions: Randomised control trials of the effect of two digital interventions, SuperKids and Play Kindly, on parent confidence and child behaviour.
Secondary ID [1] 301615 0
None
Universal Trial Number (UTN)
U1111-1254-1384
Trial acronym
Linked study record
A pilot study of one of the interventions being trialled was registered under: ACTRN12618001413213 (U1111-1219-0051)

Health condition
Health condition(s) or problem(s) studied:
Childhood Behavioural Difficulties 318000 0
Condition category
Condition code
Mental Health 316032 316032 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will randomised to one of the below interventions or a waitlist control during the study period. At the conclusion of the study all participants will be given free access to both interventions. The study period will be one week (7 days). Participants will be given access to the interventions and asked to use them as much as they can in during the study week although no minimum/maximum use will be stipulated.

FIRST INTERVENTION
SuperKids
SUPERKIDS is a web-based application (app) accessed through a secure website with participant created details that link them to the research platform. It consists of 5 parenting skills that are utilised to improve the parent child relationship. In every session a new parenting skill will be available for the parents in short animated videos, before being guided to practice the new skill in a 5 minute power playtime during which they monitor their use of the learnt skill for the day. They parents will be expected to spend 5 minutes every day practicing the new skill in the powerplay and will be allowed to complete it at any pace from all in one sitting, through to spreading out the 5 skills across the one week intervention period.

SAY skills – talking about what the child is playing with in the powerplay, so the child is the centre of your attention for that 5 minutes. It is during this 5 minutes that the parent helps the child to learn about concepts such as colour, numbers and other school ready skills through commenting on their play rather than asking them to questions.
U follow skills – teaches play therapy skills, so that the parent simply follows the child’s lead in the play. Following the child’s lead means the child is in control of the play and is able to stay focussed and settled.
Praise skills – exactly what you like and why you like it.
Enjoy skills – parent learns to show their child that they are enjoying playing with them through verbal, physical and facial expressions.
Redirect skills – these are the skills to redirect a child away from potentially annoying situations and return their attention back to positive play time activities.

SECOND INTERVENTION
Play Kindly
Play Kindly is is a native application (app on iOS & Android) accessed through an installed app on their device with participant created details that link them to the research platform. It is a behavioural parenting interventions that has been designed for Pacific families. It is utilises short animations to demonstrate difficulties and a game format to teach responses.
Play Kindly consists of seven scenarios demonstrating common behavioural problems and asks parents the appropriate way to respond to these situations. Feedback is given about their answers. Each scenario is approximately 30 seconds long and ends where the parent has to make a decision about how to intervene.
Scenario 1:
A boy is playing with a tablet. His little sister comes along and asks for the tablet. The brother refuses to give her the tablet and the she keeps pestering him for it. The boy calls out to the mother for help.
Scenario 2:
A mother tries to get her daughter to eat dinner. The daughter refuses to eats and responds disrespectfully to her mother.
Scenario 3:
A brother and sister are playing with their toy cars. The brother asks the sister for her car. When she refuses, tries to snatch the toy from her. He ends up hitting her and the girl calls for her mother
Scenario 4:
A mother asks her son to help his little sister put on her jumper. The little sister refuses. She kicks the brother as he struggles to dress her.
Scenario 5:
A father is at supermarket when his daughter asks him if he can buy her a toy. After the father refuses, the daughter throws a tantrum and lays on the floor.
Scenario 6:
Child-led play. Where the child has at least 5 minutes of leading an activity.
Scenario 7:
Positive praise. Reinforcing things parents would like to see more of.

Analytics will be gathered through both the interventions on the access and use of each of the aspects and will be linked back to their profile on the research platform, allowing assessment of adherence and engagement.
Intervention code [1] 317917 0
Behaviour
Comparator / control treatment
The unique 'three-arm' RCT design will utilise a single Waitlist Control group for both intervention, minimising the need for control participants, Waitlist participants will get access after the 7 day intervention period.
Control group
Active

Outcomes
Primary outcome [1] 324239 0
"Weekly Assessment of Child Behaviours - Positive" (WACB-P)
This scale is a well validated, freely available, questionnaire that is designed to assess changes in parent ratings of child behaviour. The WACB-P is a set of 9 positively worded questions which parents are asked to rate their agreement with on a 7-item likert scale.
(Please note this is the name of the measure rather than the frequency of the assessment in this study).
Timepoint [1] 324239 0
1 Week Post intervention commencement.
Primary outcome [2] 324240 0
Brief Assessment of Parenting (BAP)
This scale has been devised for the purposes of these studies. The questions have been chosen to reflect aspects of parenting including parenting confidence, satisfaction, parenting skill and parenting behaviour. The ten questions are designed to be user-friendly on a smartphone. Parents will be asked to rate their agreement with each statement on a 5-point likert scale. An initial evaluation on earlier parenting studies across 333 participants who completed the BAP, shows internal consistency as measured by Cronbach’s alpha at 0.804. A stable single factor. Test -Retest reliability (n=112) with an intraclass correlation coefficient of 0.775. Good concurrent validity with PSOC, the most commonly used measure of parenting sense of competence, with a Pearson’s Correlation of 0.669.
Timepoint [2] 324240 0
1 Week Post intervention commencement.
Primary outcome [3] 324241 0
In addition qualitative information about acceptability and cultural appropriateness to both Maori and Pasifika communities will also gathered through a study specific questionnaire,
Timepoint [3] 324241 0
1 week post intervention commencement,
Secondary outcome [1] 384129 0
"Weekly Assessment of Child Behaviours - Positive" (WACB-P)
(Please note this is the name of the measure rather than the frequency of the assessment in this study).
Timepoint [1] 384129 0
1 month post intervention completion,
Secondary outcome [2] 384130 0
Brief Assessment of Parenting (BAP)
Timepoint [2] 384130 0
1 month post intervention completion.
Secondary outcome [3] 385083 0
App usage behaviour in terms of the number of times the app is accessed as assesses by application analytics gathered by our research portal.
Timepoint [3] 385083 0
At 1 week post intervention commencement and 1 month post intervention completion.
Secondary outcome [4] 385084 0
Qualitative feedback in the satisfaction portion of the study specific questionnaires will be analysed using a general inductive approach. In this approach, a detailed review of the typed responses is guided by the research questions and emerging themes are identified until all the data are categorised.
Timepoint [4] 385084 0
1 week post intervention commencement.
Secondary outcome [5] 386230 0
App usage behaviour in terms of the time spent on each module as assesses by application analytics gathered by our research portal.
Timepoint [5] 386230 0
At 1 week post intervention commencement and 1 month post intervention completion.
Secondary outcome [6] 386231 0
App usage behaviour in terms of the number of modules completed as assesses by application analytics gathered by our research portal.
Timepoint [6] 386231 0
At 1 week post intervention commencement and 1 month post intervention completion.

Eligibility
Key inclusion criteria
• New Zealand based parents
• Parents need to have children between the ages of 2 years to 6 years
• The child is in the parents’ care for the majority of the time (more days than not across an average week)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Parents who are enrolled in a parenting programme or have completed one in the last 12 months
• Parents who do not have access to a smart phone or are unable to use one

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Parents will be randomised to one of three conditions by the online portal without any intervention from the researchers at this point:
1. SuperKids web app.
2. Play Kindly app.
3. One week waitlist control

Assignment to these groups will be weighted by ethnicity since Play Kindly has a particular focus on Pacific parents. Therefore those who identify with any Pacific Island ethnicities will be randomised at a rate of (1/5 to SuperKids, 2/5 to Play Kindly, 2/5 to Control). All other randomisation will be equally weighted with an even split in numbers. This process will be automated by the research portal, based on an electronic randomisation sequence developed prior to the study starting, with no direct involvement from researchers.
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
Standard descriptive statistics including means, medians, standard deviation and ranges and frequencies and percentages will be used to summarise by randomised group the participant demographic and presenting features and the app usage behaviour, including the number of times the app is accessed, the time spent on each module, the number of modules completed and the stability of the platform and the app.

Behavioural outcome measures will be summarised at each timepoint by randomised group and the changes compared between randomised groups using ANOVA, with the two planned comparisons comparing the wait list control group with each of the interventions. The differences in the changes will be summarised as means and 97.5% confidence intervals.

Usage and satisfaction data will be summarised by randomised group using means, medians, standard deviation and ranges and frequencies and percentages as appropriate.

The delayed pre and post intervention outcome data for the waitlist control group will be summarised at each time point by their second randomised group and the changes within each group compared using paired t-tests.

The primary analysis will be based on the intention-to-treat principle which will include all randomised participants. Those participants without post intervention data will be assumed to have maintained their baseline levels. Additional sensitivity analysis will utilise a per-protocol population and only include those participants with post-intervention data without major protocol violations.

Exploratory analyses will also explore the relative differences between randomised groups within individual ethnicity groups. While there is limited power for these sub-group analyses they will enable profound differences in responses to be identified.

Qualitative feedback in the satisfaction portion of the questionnaires will be analysed using a general inductive approach. In this approach, a detailed review of the typed responses is guided by the research questions and emerging themes are identified until all the data are categorised.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2020
Actual
6/10/2020
Date of last participant enrolment
Anticipated
28/02/2021
Actual
28/11/2021
Date of last data collection
Anticipated
30/04/2021
Actual
26/12/2021
Sample size
Target
400
Accrual to date
Final
435
Recruitment outside Australia
Country [1] 22692 0
New Zealand
State/province [1] 22692 0

Funding & Sponsors
Funding source category [1] 306046 0
Charities/Societies/Foundations
Name [1] 306046 0
Cure Kids Foundation
Country [1] 306046 0
New Zealand
Primary sponsor type
University
Name
Department of Psychological Medicine, FMHS, University of Auckland
Address
Private Bag 92019, Auckland, New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 306508 0
None
Name [1] 306508 0
Address [1] 306508 0
Country [1] 306508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306273 0
Auckland Health Research Ethics Committee Application (AHREC)
Ethics committee address [1] 306273 0
Private Bag 92019, Auckland 1142, New Zealand
Ethics committee country [1] 306273 0
New Zealand
Date submitted for ethics approval [1] 306273 0
20/07/2020
Approval date [1] 306273 0
12/08/2020
Ethics approval number [1] 306273 0
AH1472

Summary
Brief summary
The focus of this study is evaluating two digital parenting interventions (Play Kindly & SuperKids) that show promise in reducing some barriers to access whilst delivering effective parenting strategies on the smart devices of parents. Both of the interventions aim to address behavioural difficulties in children aged 2-6 years old through more effective parenting whilst increasing the sense of competence of those parents. The study will be delivered with rapid interventions over one week with a one month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103322 0
Prof Sally Merry
Address 103322 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 103322 0
New Zealand
Phone 103322 0
+64 9 923 6981
Fax 103322 0
Email 103322 0
[email protected]
Contact person for public queries
Name 103323 0
Dr Marthinus Bekker
Address 103323 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 103323 0
New Zealand
Phone 103323 0
+64 9 373 7599
Fax 103323 0
Email 103323 0
[email protected]
Contact person for scientific queries
Name 103324 0
Dr Marthinus Bekker
Address 103324 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 103324 0
New Zealand
Phone 103324 0
+64 9 373 7599
Fax 103324 0
Email 103324 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
Not in participant consent


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8320Study protocol  [email protected]
8321Ethical approval  [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.