Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001040156
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
23/07/2019
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kakano: trial of a parenting app to help manage big emotions
Scientific title
Kakano: stepped wedge trial of a parenting app to manage big emotions for families/whanau living in the Christchurch region.
Secondary ID [1] 298547 0
Nil known
Universal Trial Number (UTN)
U1111-1235-7502
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting 313369 0
Child behaviour 313370 0
Condition category
Condition code
Mental Health 311812 311812 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 312079 312079 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Kanano app has been codesigned by the research team and whanau in the Christchurch region and is being tested for efficacy in this trial. Kakano is an online parenting resource developed through a codesign process invovling parents and researchers. It supports parents to set up to three whanau (family) goals to work towards each week using the values of Tika (doing things in the right way and order), Pono (doing things with honesty and integrity) and Aroha (doing things with love, compassion, and sense of service to others, and with joy). Tika, Pono and Aroha are the key components of Mana (pride/strength) within Te Ao Maor (Maori world view)i, and consultation has confirmed that this framework is acceptable to local Kaumatua (elders) and
welcomed by most of the parents surveyed, particularly Maori. The app contains goal-setting steps, information about strategies to manage distress (chillers section), and rewards in the form of stickers that can be assigned to whanau members for their positive and skilful behaviour. The app is designed to be used at least weekly for ten minutes over a period of 4 weeks to help parents keep track of their whanau goals and to manage distress ("big emotions") within the whanau.

As this is a stepped wedged trial, participants will be block randomised by schools to either receive the app immediately or have delayed access to the app. The delayed access period is 4 weeks, after which participants will have access to the app. After the 4 week period of using the app, participants can continue to use the app if they wish.

Adherence will be measured by online activity collected electronically by the server hosting the Kakano application.
Intervention code [1] 314802 0
Behaviour
Intervention code [2] 315001 0
Treatment: Devices
Comparator / control treatment
we are using a waiting list (delayed access) control of four weeks starting from completion of baseline measures
Control group
Active

Outcomes
Primary outcome [1] 320481 0
Mobile App Parenting Scale (MAPS): this is a purpose designed scale designed to assess parenting skill and confidence. The scale has been developed based on the Parenting Sense of Confidence (PSOC; Johnston & Mash, 1989), and the Weekly Assessment of Child Behaviour – Positive Behaviours (WACB-P; Forte, Boys & Timmer, 2012) and has been modified using the clinical expertise within the research team.
Timepoint [1] 320481 0
Collected at baseline and post-intervention (4 weeks) for the immediate access group
For the delayed access group, this will be collected online at Baseline, After Waitlist period (4 weeks post baseline), and Post intervention (8 weeks after baseline)
Primary outcome [2] 320482 0
Mental health wellbeing as assessed by the Warwick-Edinburgh Mental Wellbeing Scale: short version (SWEMWBS): .
Timepoint [2] 320482 0
For the immediate access group this will be collected online at Baseline, and at Post-intervention (4 weeks after baseline).
For the delayed access group, this will be collected online at Baseline, After Waitlist period (4 weeks post baseline), and Post intervention (8 weeks after baseline)
Primary outcome [3] 320483 0
The Brief Parental Self Efficacy Scale (BPSES) The Brief Parental Self-Efficacy Scale assesses a parent’s belief that they can effectively perform or manage tasks related to parenting of their child. The scale is recommended by the Child Outcomes Research Consortium (www.corc.uk) for use in the evaluation of parent training. The scale is not normalised and is intended as a change index within an individual.

Timepoint [3] 320483 0
For the immediate access group this will be collected online at Baseline, and at Post-intervention (4 weeks after baseline).
For the delayed access group, this will be collected online at Baseline, After Waitlist period (4 weeks post baseline), and Post intervention (8 weeks after baseline)
Secondary outcome [1] 371771 0
The Family Adaptability and Cohesion Scale (FACES-IV) was developed to evaluate the adaptability and cohesion dimensions in family interactions. FACES IV Package includes the Family Communication Scale and Family Satisfaction Scale 0-62 items. Olson, D. H. (1985). FACES III (Family Adaptation and Cohesion Scales). St. Paul, MN: U of Minnesota. The 9 items from FACES used by Growing Up in New Zealand will be used.
Timepoint [1] 371771 0
For the immediate access group this will be collected online at Baseline, and at Post-intervention (4 weeks after baseline).
For the delayed access group, this will be collected online at Baseline, After Waitlist period (4 weeks post baseline), and Post intervention (8 weeks after baseline)
Secondary outcome [2] 371772 0
Parenting competences as assessed by The Parenting Sense of Competence Scale (PSOC).
Timepoint [2] 371772 0
For the immediate access group this will be collected online at Baseline, and at Post-intervention (4 weeks after baseline).
For the delayed access group, this will be collected online at Baseline, After Waitlist period (4 weeks post baseline), and Post intervention (8 weeks after baseline)
Secondary outcome [3] 371773 0
Weekly satisfaction measure: We will assess parent’s satisfaction with treatment regularly through the time that they use the resource using an online data collection procedure. Participants will be sent a link to an online survey (using smart phones or email according to participant preference) and asked to rate how things have been for them and whether the intervention skills have been helping. This measure has been designed specifically for this study by the research team.
Timepoint [3] 371773 0
Weekly while using the trial
Secondary outcome [4] 371774 0
Satisfaction with the intervention: Children and their parents will be asked to complete a brief purpose designed questionnaire to rate their satisfaction with components of the intervention. This questionnaire has been designed for this study. They will be asked about things they liked/did not like about the intervention, which aspects they found most/least helpful, whether they would recommend it to their friends and how it could be improved in the future.
Timepoint [4] 371774 0
Collected at post-intervention (4 weeks after being given access to the Kakano intervention)
Secondary outcome [5] 371775 0
Number of goals set
Timepoint [5] 371775 0
Collected as a numerical count from the trial server post-intervention (4 weeks after getting access to the app)
Secondary outcome [6] 372604 0
Number of components of the app visited
Timepoint [6] 372604 0
Collected as a numerical count from the trial server post-intervention (4 weeks after getting access to the app)

Eligibility
Key inclusion criteria
1. Parents or carers of one or more children aged 5-12 years of age;
2. Children are attending school at one of the identified recruitment schools;
3. Have access to a web-enabled technology that is able to install and run the app;
4. Are self-reported to be struggling with parenting or want to learn more skills to aide their parenting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently receiving public or private parenting support or training, or have done in the past year;
2. Being unable to read, write or speak conversational English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
25/02/2020
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 21624 0
New Zealand
State/province [1] 21624 0
Canterbury

Funding & Sponsors
Funding source category [1] 303094 0
Charities/Societies/Foundations
Name [1] 303094 0
Cure Kids Research Grant
Country [1] 303094 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Research Office
The University of Auckland
Private Bage 92019
Auckland 1014
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303083 0
None
Name [1] 303083 0
Address [1] 303083 0
Country [1] 303083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303638 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 303638 0
Ethics committee country [1] 303638 0
New Zealand
Date submitted for ethics approval [1] 303638 0
Approval date [1] 303638 0
20/06/2019
Ethics approval number [1] 303638 0

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

Contacts
Principal investigator
Name 94354 0
Dr Lucy D'Aeth
Address 94354 0
Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140
Country 94354 0
New Zealand
Phone 94354 0
+64 27 3222533
Fax 94354 0
Email 94354 0
lucy.daeth@cdhb.health.nz
Contact person for public queries
Name 94355 0
Lucy D'Aeth
Address 94355 0
Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140
Country 94355 0
New Zealand
Phone 94355 0
+64 27 3222533
Fax 94355 0
Email 94355 0
lucy.daeth@cdhb.health.nz
Contact person for scientific queries
Name 94356 0
Lucy D'Aeth
Address 94356 0
Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140
Country 94356 0
New Zealand
Phone 94356 0
+64 27 3222533
Fax 94356 0
Email 94356 0
lucy.daeth@cdhb.health.nz

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
3068Study protocol  Lucy.Daeth@cdhb.health.nz
3069Clinical study report  Lucy.Daeth@cdhb.health.nz
3070Ethical approval  Lucy.Daeth@cdhb.health.nz



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.