ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000892314

Ethics application status

Approved

Date submitted

15/06/2017

Date registered

19/06/2017

Date last updated

18/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot trial of the iENGAGE Program; games for mothers to play with their children to improve children’s self-control.

Scientific title

A pilot trial of the iENGAGE Program; games for mothers to play with their children to improve children’s self-control.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Self-control in difficult to manage children (see private notes in answer to your queries)

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This pilot trial aims to test feasibility, acceptability, and preliminary efficacy of a novel online program called iENGAGE that seeks to help mothers teach self-control to their young children.

The online iENGAGE program is developed based on the established face-to-face ENGAGE program by Healey and Halperin (2015) in New Zealand. The iENGAGE Program is a self-managed, 10 week online intervention consisting of 6 lessons completed by the mother alone online. During these lessons, which take approximately 30 minutes each to complete, the mother learns how to introduce to and play games with her child to improve self-control. These games are designed to teach self-control in fun and functional ways appropriate to a child (e.g. musical statues to teach the child how to stop/stand still when asked), and as a result build the strengths of the child and bolster the child-parent relationship. These lessons are complemented with homework tasks (called lesson summaries) which allow the mother to continue to practice the skills learned in the lessons.

Adherence to the program will be monitored using the online software platform called Virtual Clinic, which records lesson access and completion, whether homework is downloaded, as well as sends helpful reminders to mothers when the next lesson is available or if a lesson is not completed.

Mother's ratings of their child's conduct and hyperactivity will be assessed before and after the iENGAGE program, as well as mother's self ratings of the child-parent relationship.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

NIL. This is a pilot study to test the feasibility, acceptability, and preliminary efficacy of a novel program.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Conduct and hyperactivity problems; Change scores from baseline on the Strengths and Difficulties Questionnaire (SDQ)

Timepoint [1]

Post-treatment (one week after finishing iENGAGE - Week 11); 1 month follow-up, & 3 month's follow-up.

Primary outcome [2]

Child-parent relationship; Change scores from baseline on the Child-Parent Relationship Scale (CPRS).

Timepoint [2]

Post-treatment (one week after finishing iENGAGE - Week 11); 1 month follow-up; & 3 month's follow-up.

Secondary outcome [1]

Acceptability of the intervention: Change scores from baseline on the Credibility/Expectancy Questionnaire (CEQ)

Timepoint [1]

Post-treatment (one week after finishing iENGAGE - Week 11)

Secondary outcome [2]

Attrition and adherence: number of participants that complete the program, download the homework, withdraw, or drop-out.

Timepoint [2]

Post-treatment (one week after finishing iENGAGE - Week 11)

Eligibility

Key inclusion criteria

Mothers with children who are 1) aged 3 or 4; 2) attend pre-school; 3) not taking medication for a chronic medical condition; and 4) rated by their mothers as > or = 4 on the conduct problems sub-scale and/or > or = 6 on the hyperactivity sub-scale (scores indicative of significantly elevated difficulties in these areas compared to the general population of 2-4 year old children) on the Strengths and Difficulties Questionnaire (SDQ).

(see private notes in answer to your age and gender queries)

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria: mothers aged less than 18, have English language skills less than School Certificate level, no access to a phone, or no access to a computer. It is also recommended that mothers have a printer in order to print out lesson summaries and course resources to avoid spending excess time at the computer; however this is not an exclusion criteria. Eligible participants must provide electronic informed consent.

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)

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

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

In order to detect a difference on the primary outcome measure (SDQ score) between baseline and post-treatment, recruitment of 30 mother/child dyads will enable us to detect an effect size of 0.54, at 80% power, and alpha set at 0.05. This effect size estimate is very conservative.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/11/2017

Actual

20/09/2017

Date of last participant enrolment

Anticipated

18/06/2018

Actual

23/11/2017

Date of last data collection

Anticipated

17/09/2018

Actual

7/03/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

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

Recruitment hospital [1]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Clinical Research Unit for Anxiety and Depression

Address [1]

Clinical Research Unit for Anxiety and Depression
Level 4, O'Brien Centre
390 Victoria Street
Darlinghurst NSW 2010

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital Sydney

Address

390 Victoria Street, Darlinghurst NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales HREC Committee B

Ethics committee address [1]

Human Ethics Office
Level 3, Rupert Myers Building (South Wing) 
The University of New South Wales
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/04/2017

Approval date [1]

31/05/2017

Ethics approval number [1]

HC17290

Summary

Brief summary

The Dunedin Child Development study is tracking a birth cohort of 1,000 people born in Dunedin, New Zealand in 1972, Poor self-control was found to be a strong predictor of membership of the 20% of individuals who, over the next four decades, generated 80% of all health, social welfare and crime costs in the cohort studied. This finding has attracted considerable attention from colleagues, policy makers, media, and the public as to the importance of self-control skills mastered in childhood for success in all facets of adult life. Improved self-control could therefore be an attractive intervention target. 

In this vein, Healey and Halperin (2015) developed an early intervention programme called ENGAGE aimed at coaching mothers to foster the development of self-control in their difficult to manage pre-schoolers. The mothers learnt or re-learnt familiar games (Simon Says, Musical Statues etc) directed at teaching child self-control and were encouraged to implement these with their children between clinic visits. Gains were large and were maintained over a twelve month follow up period. 

The ENGAGE study established the practicality of this face-to-face or clinic intervention in child self-control. However, for use on a population basis, this programme would need to be automated for web-based delivery. The Clinical Research Unit for Anxiety and Depression (CRUfAD) at St Vincent’s Hospital, Sydney have developed a web-based version of the ENGAGE course called iENGAGE. The iENGAGE Program is a self-managed, 10 week online intervention consisting of 6 lessons involving participation in games to improve self-control. These games are designed to teach self-control in fun and functional ways appropriate to a child (e.g. musical statues to teach the child how to stop/stand still when asked), and as a result build the strengths of the child and bolster the child-parent relationship. The online iENGAGE programme offers the advantages of being cost-effective, widely distributed (including in rural areas), available at a time and place convenient to the user, private and confidential, self-empowering, and deliverable with high fidelity.

We wish to conduct a pilot trial of iENGAGE to test feasibility, acceptability, and preliminary efficacy of the online program in improving self-control in difficult to manage children as rated by their mothers. Results will be used to improve iENGAGE before passing the augmented program to Professor Rapee at Macquarie University to conduct a randomised controlled trial to establish efficacy and safety. Once efficacy and safety are established, CRUfAD will adapt the program for a large cluster RCT in New Zealand preschools. If this is successful then CRUfAD will adapt it for use as an integral part of New Zealand early childhood services delivered by the Plunkett Society.

Trial website

www.virtualclinic.org.au

This website is where the participants are directed to to access the trial being registered. Participants must go to this web address in order to log on and access their lessons. There is web address specific to the iENGAGE program provided.

Trial related presentations / publications

Nil as of yet

Public notes

Contacts

Principal investigator

Name

Prof Gavin Andrews

Address

Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 8382 1400

Fax

gavina@unsw.edu.au

Contact person for public queries

Name

Ashlee Grierson

Address

Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 8382 1421

Fax

ashlee.grierson@svha.org.au

Contact person for scientific queries

Name

Ashlee Grierson

Address

Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre,
St Vincent's Hospital,
394-404 Victoria St,
Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 8382 1421

Fax

ashlee.grierson@svha.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

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.

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