Trial Review

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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] 292204 0
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) 303691 0
Condition category
Condition code
Public Health 303063 303063 0 0
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] 298358 0
Treatment: Other
Intervention code [2] 298359 0
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] 302441 0
Conduct and hyperactivity problems; Change scores from baseline on the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [1] 302441 0
Post-treatment (one week after finishing iENGAGE - Week 11); 1 month follow-up, & 3 month's follow-up.
Primary outcome [2] 302442 0
Child-parent relationship; Change scores from baseline on the Child-Parent Relationship Scale (CPRS).
Timepoint [2] 302442 0
Post-treatment (one week after finishing iENGAGE - Week 11); 1 month follow-up; & 3 month's follow-up.
Secondary outcome [1] 336019 0
Acceptability of the intervention: Change scores from baseline on the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [1] 336019 0
Post-treatment (one week after finishing iENGAGE - Week 11)
Secondary outcome [2] 336064 0
Attrition and adherence: number of participants that complete the program, download the homework, withdraw, or drop-out.
Timepoint [2] 336064 0
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
30
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 8381 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 16449 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 296743 0
Other
Name [1] 296743 0
Clinical Research Unit for Anxiety and Depression
Country [1] 296743 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria Street, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 295717 0
None
Name [1] 295717 0
Address [1] 295717 0
Country [1] 295717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297969 0
University of New South Wales HREC Committee B
Ethics committee address [1] 297969 0
Human Ethics Office
Level 3, Rupert Myers Building (South Wing)
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 297969 0
Australia
Date submitted for ethics approval [1] 297969 0
26/04/2017
Approval date [1] 297969 0
31/05/2017
Ethics approval number [1] 297969 0
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 75618 0
Prof Gavin Andrews
Address 75618 0
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 75618 0
Australia
Phone 75618 0
+61 2 8382 1400
Fax 75618 0
Email 75618 0
[email protected]
Contact person for public queries
Name 75619 0
Mrs Ashlee Grierson
Address 75619 0
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 75619 0
Australia
Phone 75619 0
+61 2 8382 1421
Fax 75619 0
Email 75619 0
[email protected]
Contact person for scientific queries
Name 75620 0
Mrs Ashlee Grierson
Address 75620 0
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 75620 0
Australia
Phone 75620 0
+61 2 8382 1421
Fax 75620 0
Email 75620 0
[email protected]

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.