ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

U1111-1235-7502

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parenting

Child behaviour

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

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]

Behaviour

Intervention code [2]

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]

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]

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]

Mental health wellbeing as assessed by the Warwick-Edinburgh Mental Wellbeing Scale: short version (SWEMWBS): .

Timepoint [2]

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]

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]

Secondary outcome [1]

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]

Secondary outcome [2]

Parenting competences as assessed by The Parenting Sense of Competence Scale (PSOC).

Timepoint [2]

Secondary outcome [3]

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]

Weekly while using the trial

Secondary outcome [4]

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]

Collected at post-intervention (4 weeks after being given access to the Kakano intervention)

Secondary outcome [5]

Number of goals set

Timepoint [5]

Collected as a numerical count from the trial server post-intervention (4 weeks after getting access to the app)

Secondary outcome [6]

Number of components of the app visited

Timepoint [6]

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cure Kids Research Grant

Address [1]

96 New North Rd, Eden Terrace, Auckland 1021, New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disabilities Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

20/06/2019

Ethics approval number [1]

Summary

Brief summary

This study proposes to assess the acceptability and feasibility of an app designed to improve parenting competence. Whanau (families) will be recruited for the study through their school regions by the mental health support teams of the school (Kaimahi's). Once recruited into the study, whanau will either be given immediate access to the app, or delayed access and given access after 4 weeks. Recruitment will occur in two waves. Wave two will follow the same design for access (immediate access or delayed by a waitlist) with those who are getting immediate access to the app gaining access to the app four weeks after the initial group gains access in wave 1.
Participants will complete measures on parenting competence, wellbeing, parental efficacy, and satisifacation with the intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lucy D'Aeth

Address

Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140

Country

New Zealand

Phone

+64 27 3222533

Fax

[email protected]

Contact person for public queries

Name

Lucy D'Aeth

Address

Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140

Country

New Zealand

Phone

+64 27 3222533

Fax

[email protected]

Contact person for scientific queries

Name

Lucy D'Aeth

Address

Canterbury District Health Board
Department of Community and Public Health
PO Box 1475
Christchurch 8140

Country

New Zealand

Phone

+64 27 3222533

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
3068	Study protocol	[email protected]
3069	Clinical study report	[email protected]
3070	Ethical 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.

Trial Review

Documents added manually

Documents added automatically