ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000621415

Ethics application status

Approved

Date submitted

11/05/2016

Date registered

13/05/2016

Date last updated

28/06/2021

Date data sharing statement initially provided

9/01/2019

Date results information initially provided

9/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Parenting Resilient Kids: Evaluating a Personalised Online Parenting Program

Scientific title

Examining the effects of an individually-tailored online parenting program (Parenting Resilient Kids) for parents of 8- to 11-year-olds, compared to a control group that receives standard educational materials about child development and wellbeing, on parental risk and protective factors associated with child depression and anxiety, as well as on child depressive and anxiety symptoms.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1182-4953

Trial acronym

Linked study record

Health condition

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

Parental risk and protective factors for the development of childhood depression and anxiety disorders

Child anxiety

Child depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention consists of an online, mobile-compatible parenting program ('Parenting Resilient Kids') which is part of a larger research translation program (Parenting Strategies; www.parentingstrategies.net). Parents will first complete an online Parent Survey (developed specifically for use in this study) that assesses their current parenting practices against the recommendations in the Guidelines 'How to reduce your child's risk of depression and clinical anxiety: strategies for parents of primary-school aged children' (Parenting Strategies Program, 2014; henceforth the Guidelines). Based on their responses to this survey, parents in the intervention group will then (1) receive an individually-tailored feedback report that highlights areas where they are doing well (i.e., concordant with the Guidelines) and areas where they can improve (i.e., not concordant with the Guidelines), and (2) be given access to the web- and app-based parenting intervention (up to 12 modules) to support them in making changes to the identified areas of weakness in their parenting. Specific modules are recommended to parents based on their responses to the baseline Parent Survey.

Feedback messages are brief, with practical strategies provided in dot point form, and are designed to motivate behaviour change. Parents in the intervention group will view their feedback report online immediately after submitting their online baseline assessment and being randomly allocated to the intervention group. They will also be emailed a copy of their feedback report and the Guidelines (in pdf). Five days later, parents will be emailed instructions for accessing the interactive parenting program with their recommended modules. Upon logging in to their parenting program, parents will see their recommended modules as well as other available modules. They can further tailor their parenting program at this stage by deselecting recommended modules and/or selecting additional modules. They then confirm their selection and can commence their personalised program. The 12 modules comprising the intervention are derived from topics covered in the Guidelines. Modules include illustrations, vignettes, interactive activities, goal-setting exercises, and an end-of-module quiz with immediate feedback to consolidate learning. The module topics include:
1) Show affection and acceptance
2) Be involved
3) Encourage autonomy
4) Make time to talk
5) Encourage healthy habits
6) Establish family rules and consequences
7) Help set goals and solve problems
8) Help your child manage emotions
9) Encourage supportive relationships
10) Manage conflict in the home
11) Help your child manage anxiety
12) Seek help.
After completing the last module in their original program, parents can elect to complete other modules if desired. Each module takes 15-25 minutes to complete. Parents are encouraged to complete one module per week. The website is programmed to unlock one module per week from each parent's program, until all modules in their personalised program have been unlocked. Once parents have completed all the modules in their personalised program, they have ongoing access to all 12 modules in the program. Their access to their parenting program will remain open indefinitely.

All parent participants, regardless of group, will receive a 5-minute weekly phone call from a researcher, starting 7 days after completing their baseline survey, and every week thereafter for at least 8 weeks. Parents in the intervention group will receive a minimum of 8 weekly calls in total, or more if they have more than 7 modules (the total number of calls will match the total number of modules selected plus one). Research staff will be trained to make these calls following a standard script (i.e. a standard list of questions and prompts), and will not provide individual advice or therapy. The aims of these calls are to address any study-related questions that arise, ascertain that parents progress through their allocated intervention each week till completion, and enhance retention.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

Parents in the control group are provided with a standardized package of educational materials about child development and mental health via the trial website. Parent participants receive an email a week which provides a link to the corresponding webpage with their information factsheet for that week, for 8 weeks (to match the expected mean number of modules received by the intervention group). This package provides general information to parents as opposed to tailored, actionable strategies, and is designed to represent a selection of resources that are available to parents as part of the current health
promotion approach for child wellbeing. The materials are adapted from credible existing resources provided on the Raising Children Network website http://raisingchildren.net.au. The control intervention is also fully online and mobile compatible.
All parent participants, regardless of group, will receive a 5-minute weekly phone call from a researcher, starting 7 days after completing their baseline survey, and every week thereafter for 8 weeks. Research staff will be trained to make these calls following a standard script (i.e. a standard list of questions and prompts), and will not provide individual advice or therapy. The aims of these calls are to address any study-related questions that arise, ascertain that parents progress through their allocated intervention each week till completion, and enhance retention.

Control group

Active

Outcomes

Primary outcome [1]

Change in parental concordance with the Guidelines 'How to reduce your child's risk of depression and clinical anxiety: Strategies for parents of primary-school aged children', from baseline to post-intervention. This will be assessed by a Parenting Survey, newly developed for use in this study. The survey consists of 83 questions, and is a criterion-referenced measure assessing parents' current parenting knowledge and behaviours against specific recommendations in the Guidelines.

Timepoint [1]

The Parenting Survey will also be completed by both the intervention and control group parent participants at the following timepoints:
Baseline (pre-intervention)
3month follow-up (post-intervention)
12 month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Primary outcome [2]

Change in child anxiety symptoms, as measured by the 15-item Total Anxiety subscale score on the Revised Children's Anxiety and Depression Scale (RCADS) short-form (25-items), from baseline to 12-month follow-up. The RCADS will be administered to both parents (parent-report form) and child (child-report form) participants.

Timepoint [2]

The parent- and child-report RCADS will be completed by both the intervention and control group (parent and child participants) at the following timepoints:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention).
24-month follow-up (21 months post-intervention).

Primary outcome [3]

Change in child depressive symptoms, as measured by the 10-item Depression subscale score on the Revised Children's Anxiety and Depression Scale (RCADS) short-form (25-items), from baseline to 12-month follow-up. The RCADS will be administered to both parents (parent-report form) and child (child-report form) participants.

Timepoint [3]

Secondary outcome [1]

Child's health-related quality of health, as measured by Child Health Utility 9D (CHU-9D) and KIDSCREEN-27. The CHU-9D will be completed by the child participant. The KIDSCREEN-27 will be completed by both the child and parent participants.

Timepoint [1]

The CHU-9D will be completed by the child participant in both intervention and control groups. The KIDSCREEN-27 will be completed by both the child and parent participants in both the intervention and control groups. The timepoints are:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Secondary outcome [2]

Child's report of parenting, as measured by the acceptance/rejection subscale of the Child's Report of Parental Behavior Inventory (CRPBI-30) and the Psychological Control Scale-Youth Self Report (PCS-YSR). These items form a measure that assesses a subset of the parenting recommendations in the Guidelines, as perceived by the child. This measure is completed only by child participants in Grades 5 and 6 (aged approximately 10-11), so as to ensure that children are able to provide valid reports on these measures.

Timepoint [2]

Child participants in both the intervention and control groups will complete the child-report parenting survey at the following timepoints:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Secondary outcome [3]

General family functioning will be measured by parent's report on the General Functioning subscale of the McMaster Family Assessment Device.

Timepoint [3]

The general functioning subscale will be completed by parents in both the intervention and control groups at the following timepoints:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Secondary outcome [4]

Parents' self-report of parenting, as measured by the acceptance/rejection subscale of the parent's form of the Child's Report of Parental Behavior Inventory (CRPBI-30) and the Psychological Control Scale-Youth Self Report (PCS-YSR). These items will be used as a complementary measure for assessing parenting, as well as to form part of the validation of the newly-developed Parenting Survey.

Timepoint [4]

The parent report of the CRPBI and PCS-YSR will be completed by both the intervention and control group parent participants at the following timepoints:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Secondary outcome [5]

Parents' health-related quality of life, as measured by the Assessment of Quality of Life (AQoL-8D). It will be completed by parent participants.

Timepoint [5]

The AQol-8D will be administered to parents in both the intervention and control groups at the following timepoints:
Baseline (pre-intervention)
3-month follow-up (post-intervention)
12-month follow-up (9 months post-intervention)
24-month follow-up (21 months post-intervention).

Eligibility

Key inclusion criteria

Parent Participants:
Parents or guardians of at least one child aged 8 to 11 years (inclusive), who reside in Australia, are fluent in English, have regular access to the internet and an email account.

Child Participants:
Children of participating parents/guardians, aged 8 to 11 (inclusive) on entry to the trial, who reside in Australia, are fluent in English, and have regular access to the internet. The child's parent must have provided consent for their child's participation, and the child must provide informed verbal assent to participate.
Only one parent and one child per family can participate in the trial.

Minimum age

8 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants have to meet all eligibility/inclusion criteria detailed above.
In addition, children who do not have parental consent to participate in the study; or who do not provide verbal assent to participate are ineligible for the study.
Note: parents can still participate if their child does not participate in the study.

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)

When parents submit their baseline assessment on the trial website, the website will generate an automated random allocation sequence to allocate parent-child dyads to either the control or intervention group. Parents find out their assignment immediately thereafter: the intervention group receives their tailored feedback, the Parenting Guidelines, and the online parenting program comprising up to 12 modules which are recommended based on their survey responses; whereas the control group receive the first of their 8 weekly factsheets. As such, allocation is concealed from both participants and researchers prior to assignment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Immediately after parents submit their baseline assessment online, the trial website is programmed to run a stratified random allocation sequence (based on parent gender) to allocate parent-child dyads to either the control or intervention group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

"The people administering the treatment/s" are "masked" because the intervention is delivered online by a fully automated trial website.

Child informants ("people assessing the outcomes") are assumed to be blinded because they are not direct recipients of the online parenting intervention.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Required sample size:
Based on a power analysis, for a repeated-measures design with a power of 0.80, small effect size (Cohen's d=0.2), and alpha level of 0.05, a sample size of 294 parent-child dyads (147 dyads per group) is required. Based on an expected attrition rate of approximately 10-15%, we aim to recruit 340 parent-child dyads (170 dyads per group).

Data analysis:
The primary analyses will be intent-to-treat analyses. To assess group differences in changes in parental concordance with the Guidelines (primary outcome 1) and child depression and anxiety symptoms (primary outcomes 2 and 3) across timepoints (baseline, and 3-month [primary outcome 1], 12-month follow-up [primary outcomes 2 and 3]) or 24-month follow-up [primary outcomes 2 and 3]), mixed model of repeated measures (MMRM) will be conducted. The MMRM uses all available data, and produces unbiased estimates of intervention effects under the assumption that data are missing completely at random or missing at random.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/03/2017

Actual

15/03/2017

Date of last participant enrolment

Anticipated

Actual

31/03/2018

Date of last data collection

Anticipated

7/06/2020

Actual

27/07/2020

Sample size

Target

680

Accrual to date

Final

697

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Faculty Strategic Grants Scheme, Faculty of Medicine, Nursing and Health Sciences (SGS16-0406), Monash University.

Address [1]

Faculty of Medicine, Nursing and Health Sciences
Monash University,
Victoria 3800
Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Australian Rotary Health

Address [2]

Australian Rotary Health
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Marie Yap

Address

18 Innovation Walk
Clayton
Monash University,
Victoria 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

Monash University Human Research Ethics Committee (MUHREC)
Room 111, Building 3e
Research Office
Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2016

Approval date [1]

12/02/2016

Ethics approval number [1]

CF16/152 - 2016000063

Summary

Brief summary

This study aims to evaluate the effects of an individually-tailored online parenting program on parenting behaviours associated with childhood depression and anxiety disorders, and in turn child anxiety and depressive symptoms. The program is designed to provide parents with (1) personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their child' risk of depression and anxiety, and (2) specific modules of the mobile-compatible online parenting intervention, recommended based on their survey responses, to support them in making changes to identified areas for improvement in their parenting.

Trial website

www.parentingresilientkids.com

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/370622-2016000063 Approval Certificate.pdf

Contacts

Principal investigator

Name

A/Prof Marie Yap

Address

School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800

Country

Australia

Phone

+61 3 9905 0723

Fax

[email protected]

Contact person for public queries

Name

Ms Wan Hua Sim

Address

School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800

Country

Australia

Phone

+61 3 9905 1232

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Marie Yap

Address

School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Clayton
Victoria 3800

Country

Australia

Phone

+61 3 9905 0723

Fax

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

Deidentified individual trial participant-level data underlying published results only will be made available in an online depository (e.g. Figshare).

When will data be available (start and end dates)?

Data will be released in phases immediately following each corresponding publication, from mid 2019 (anticipated publication date of first paper reporting results from the trial). No end date has yet been determined.

Available to whom?

Deidentified data will be available only to researchers who provide a methodologically sound proposal, by contacting the Primary Sponsor with a request for the data.

Available for what types of analyses?

Data for running the analyses to achieve the aims in the approved proposal, or for IPD meta-analyses, will be provided.

How or where can data be obtained?

Depending on the nature of the request, access to data will be subject to approvals by the Principal Investigator, with a requirement to sign a data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
993	Study protocol				Fernando LMN, Sim WH, Jorm AF, Rapee R, Lawrence K... [More Details]	370622-(Uploaded-09-01-2019-13-25-15)-Study-related document.pdf
12293	Other	Sim, W. H., Jorm, A. F., Lawrence, K. A., & Yap, M. B. H. (2019). Development and evaluation of the Parenting to Reduce Child Anxiety and Depression Scale (PaRCADS): assessment of parental concordance with guidelines for the prevention of child anxiety and depression. PeerJ, 7, e6865. doi:10.7717/peerj.6865	https://doi.org/10.7717/peerj.6865		Sim, W. H., Jorm, A. F., Lawrence, K. A., & Yap, M... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Sim, W. H., Fernando, L. M. N., Jorm, A. F., Rapee... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A tailored online intervention to improve parenting risk and protective factors for child anxiety and depression: Medium-term findings from a randomized controlled trial.	2020	https://dx.doi.org/10.1016/j.jad.2020.09.019

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically