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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000892314

Enrollment

Registered

2017-06-19

Start date

2017-09-20

Completion date

2017-11-23

Last updated

2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

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.

Outcome results