Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001413213
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
24/08/2018
Date last updated
7/08/2020
Date data sharing statement initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Play Kindly, A Gamified Parenting App, Reduce Behavioural Problems in Children
Scientific title
Does the parenting app Play Kindly, help parents adjust their parenting styles and reduce behaviours in children
Secondary ID [1] 295813 0
None
Universal Trial Number (UTN)
U1111-1219-0051
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Behavioural Difficulties 309253 0
Condition category
Condition code
Mental Health 308125 308125 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Play Kindly is a computer app that can be used on a smartphone (iPhone or android) or tablet. It was designed in New Zealand with the aim of teaching effective parenting strategies for common childhood behavioural problems. Whilst its content consists of strategies evidenced to work with different populations, the interface (characters, scenarios and voices) is designed to appeal to Pacific peoples, a population group with a higher risk of behavioural problems in childhood and later life. Play Kindly consists of five scenarios demonstrating common behavioural problems and two scenarios demonstrating positive parenting techniques. Each scenario is approximately 30 seconds long. The first five scenarios end where the parent has to make a decision about how to intervene. Feedback is given about their answers. The last two demonstrate positive parenting techniques and asks questions about how much the app user can remember from the scenario.

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.

The intervention will be delivered on the participating parent's own mobile device when ever they choose throughout the six week intervention period. No minimum or maximum amount of use will be required as the amount of use will be an outcome variable.
Intervention code [1] 312144 0
Behaviour
Comparator / control treatment
No control group - Open Trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307103 0
Strengths and Difficulties Questionnaire (SDQ). The Strengths and Difficulties questionnaire (SDQ) is a free of charge, brief behavioural screening questionnaire available for children in the age ranges of 2-16 and is widely used in research. It is a 25 item questionnaire divided between five scales. These scales are 1) emotional symptoms 2) conduct problems 3) hyperactivity/inattention symptoms 4) peer relationship problems 5) prosocial behaviour and are added together to give a total difficulties score. The extended versions asks whether the respondent thinks the young person has a problem, and if so, enquires about its chronicity, distress caused, social impairment, and burden to others.
Timepoint [1] 307103 0
Baseline and again at completion of study (6 weeks after baseline).
Primary outcome [2] 307104 0
Weekly Assessment of Child Behaviours – Positive (WACB-P). 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.
Timepoint [2] 307104 0
Baseline and repeated weekly until completion of study (6 weeks after baseline).
Primary outcome [3] 307105 0
Parenting Sense of Competence Scale (PSOC). This brief 16-item scale is designed to measure parents’ confidence and satisfaction with their parenting. Parents are asked to rate how strongly they agree or disagree with a series of statements on a 6 point likert scale. The scale yields scores in two dimensions: efficacy and satisfaction.
Timepoint [3] 307105 0
Baseline and again at completion of study (6 weeks after baseline).
Secondary outcome [1] 350701 0
Mobile App Parenting Scale (MAPS) Created for study. The questions have been chosen to reflect aspects of parenting including parenting confidence, satisfaction, parenting skill and parenting behaviour. The questions are designed to be user-friendly on a smartphone and will be evaluated against the Parenting Sense of Competence Scale as part of the analysis. Parents will be asked to rate their agreement with each statement on a 4-point likert scale.
Timepoint [1] 350701 0
Baseline and again at completion of study (6 weeks after baseline).
Secondary outcome [2] 350702 0
Usage data. How often, how long for, and which aspects of the app is used will be recorded in a composite of each users data. This data will be gathered by the internal application analytics which is automatically linked to each participant's research profile through a custom made online platform that each user will be registered through.
Timepoint [2] 350702 0
Throughout the 6 weeks intervention.
Secondary outcome [3] 350703 0
Satisfaction feedback. Parents will be asked to complete a brief questionnaire made for this study to rate their satisfaction with the app using a Likert Scale.
Timepoint [3] 350703 0
At completion of study (6 weeks after baseline).
Secondary outcome [4] 351078 0
Semi-structured qualitative interview to obtain more in depth information about whether the app changed a parent’s view of knowledge, understanding, attitudes to parenting, and change in parenting practices.
Timepoint [4] 351078 0
At completion of study (6 weeks after baseline).

Eligibility
Key inclusion criteria
New Zealand born parents of at least one Pacific ethnicity.
Have Children between the ages of 2 years old and 5 years old.
The child is in the participting parents’ care for at least 50% of the time
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 smartphone or are unable to use one.
Parents of children who have a pre-existing mental health condition.
Individuals with a connection to the Play Kindly Study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size has been predominantly selected to provide a small representative sample from different Pacific communities to test the intervention and protocol before a larger scale RCT is commenced. We aim to recruit between 20 and 30 New Zealand born parents of Pacific ethnicity for this open trial. To reflect the demographic nature of Pacific Island parents in New Zealand we will aim to recruit 10-15 parents of primarily Samoan ethnicity, 5-10 parents of Tongan ethnicity, 5-10 parents of Cook Island ethnicity and 1-2 parents from other Pacific Island ethnicities.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2018
Actual
15/03/2019
Date of last participant enrolment
Anticipated
1/10/2018
Actual
4/06/2019
Date of last data collection
Anticipated
19/11/2018
Actual
5/07/2019
Sample size
Target
30
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 20778 0
New Zealand
State/province [1] 20778 0
Auckland

Funding & Sponsors
Funding source category [1] 300407 0
Charities/Societies/Foundations
Name [1] 300407 0
Cure Kids Foundation
Country [1] 300407 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] 299866 0
None
Name [1] 299866 0
Address [1] 299866 0
Country [1] 299866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301213 0
University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 301213 0
Ethics committee country [1] 301213 0
New Zealand
Date submitted for ethics approval [1] 301213 0
12/06/2018
Approval date [1] 301213 0
09/08/2018
Ethics approval number [1] 301213 0
021453

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

Contacts
Principal investigator
Name 86246 0
Prof Sally Merry
Address 86246 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 86246 0
New Zealand
Phone 86246 0
+64 9 923 6981
Fax 86246 0
Email 86246 0
[email protected]
Contact person for public queries
Name 86247 0
Rebecca Slykerman
Address 86247 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 86247 0
New Zealand
Phone 86247 0
+64 9 923 1132
Fax 86247 0
Email 86247 0
[email protected]
Contact person for scientific queries
Name 86248 0
Rebecca Slykerman
Address 86248 0
Department of Psychological Medicine, FMHS, Private Bag 92019, Auckland, New Zealand 1142.
Country 86248 0
New Zealand
Phone 86248 0
+64 9 923 1132
Fax 86248 0
Email 86248 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8729Study protocol  [email protected]
8730Informed consent form  [email protected]
8731Ethical approval  [email protected]
8732Clinical study report  [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.