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Trial registered on ANZCTR


Registration number
ACTRN12617001432303
Ethics application status
Approved
Date submitted
2/10/2017
Date registered
10/10/2017
Date last updated
10/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing ENGAGE and Triple P: Treatment programmes for hyperactive preschoolers
Scientific title
Comparing ENGAGE and Triple P: Treatment programmes for hyperactive preschoolers
Secondary ID [1] 293018 0
nil known
Universal Trial Number (UTN)
U1111-1202-9491
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-regulation 304929 0
Attention Deficit Hyperactivity Disorder (ADHD) 304974 0
Condition category
Condition code
Mental Health 304255 304255 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhancing Neurobehavioural Gains with the Aid of Games and Exercise (ENGAGE). This intervention involved parents and children attending a weekly 1.5hour group session for five weeks; run by a clinical psychologist with specialist training in administering ENGAGE and over 5 year experience in the area of child clinical psychology. , These sessions were followed by two weeks of individual phone calls and then a final group session in the 8th week. While attending the intervention, a group of up to five parents were together in one room where they were taught a new set of games each week, over 5 weeks, and asked to play them with their children for 30 minutes a day. The games were provided within a manual given to each parent. All of the games targeted neurocognitive areas known to be associated with self-regulation (see below for a list of all the games along with a brief description). In an adjacent room, the children were taught the same games so as to familiarize them with the games, engage them in the activities, and make it easier for parents to introduce the games to them at home. When all of the games had been taught (after the first 5 weeks), parents were encouraged to continue to play the games for the remaining 3 weeks of the intervention, increasing the complexity of the games as their child developed the skills. They then received individual phone calls once a week for two weeks (Session 6 & 7) where they were aided in further individualizing the program to their own child and any issues or questions were addressed by the clinical psychologist who had been facilitating the groups. Following this a final group session was held (session 8. This was in the form of a booster session and focused on maintenance of the program over time. While the active intervention lasted 8 weeks in total, parents were encouraged to continue to play the games once the intervention sessions had ceased.
Intervention adherence was assessed via daily diaries that parents completed regarding which games they played each day and for how long.

List of the games included in the ENGAGE programme.

Games targeting Behavioural Self-Regulation:
Musical Statues - Move around while music is playing. Freeze when the music stops
Animal Speeds - Regulate the speed of your activity between small, moderate, and fast speeds
Skipping - Regulate the speed at which skipping occurs
Ball and Spoon Race - Hold a spoon with a ball on it and move from one place to another at varying speeds
Simon Says - Repeat an action if Simon says to do “this” but do not repeat an action when Simon says do “that”
Snap - Card game where if identical cards are placed down in a sequence, you place your hand on the cards and say “Snap”
Hop Scotch - Aim a token for the correct number in the sequence and hop to that number
Drawing
Improve fine motor control through drawing
Leap Frog - Remain still while other jump over you and wait until it is your turn to jump over others

Games targeting Cognitive Self-Regulation
Copy Me - Watch a sequence. Then repeat the sequence from memory
Object Copy - Observe and structure being built. Re-create the structure from memory
Ball Games - Various games that involve having to focus on the ball and catch it
Puzzles - Complete puzzles
Cups Memory - Remember which cups have been picked up and the token underneath removed
Card Memory - Remember where the matching card is and turn over 2 matching cards to collect a pair
Beading - Thread beads either from memory of a sequence or according to various changing rules
Tracking Memory - Watch cups being moved around on a table and afterward identify which one has the token under it
List Memory - Remember a list that is continually being added to
Sorting - Sort various materials according to different rules

Games targeting Emotional Self-Regulation:
Relaxation - Various exercises involving tension and relaxation of muscles
Deep Breathing - Learn to breathe in by filling your stomach with air (like a balloon) and then breath out slowly
Yoga exercises
Rhythmic drawing
Intervention code [1] 299265 0
Treatment: Other
Comparator / control treatment
Triple P (Positive Parenting Programme) is an extensively studied, well validated, gold standard behaviour management programme designed to teach parents skills in managing their children's challenging behaviour.
Standard levle 4 group Triple P was used in this study. It is an 8 week programme. For the first 4 weeks (Sessions 1-4) a group of up to 5 parents attended a weekly 1.5 hour session where they were taught 17 core child management strategies. These were divided into 10 strategies used to promote positive development (e.g., talking with children, physical affection, spending quality time together, setting a good example) and 7 strategies for managing misbehaviour (e.g., setting rules, ignoring unwanted behaviours, time-out). They received a manual with information on all of these strategies explained inside. After 4 weeks, parents received 3 weekly phone calls (Sessions 5-7) designed to help parents continue to implement the strategies taught in sessions 1-4. In the eighth week (Session 8) of the programme parents attended a final group session focused on maintenance of the programme.
The programme was administrated by a clinical psychologist (who was not a member of the research team and blind to our specific research hypotheses), The psychologist had received formal training in Triple P and was an accredited Triple P practitioner.
Treatment adherence was monitored via daily diaries recording strategies used to manage difficult behavior.
Control group
Active

Outcomes
Primary outcome [1] 303538 0
Scores for Hyperactivity on the parent rated BASC-2
Timepoint [1] 303538 0
Post-intervention (primary time point), 6 and 12 months (follow-up).
Primary outcome [2] 303564 0
Scores for Attention Problems on the parent rated BASC-2
Timepoint [2] 303564 0
Post-intervention (primary time point), 6 and 12 months (follow-up).
Primary outcome [3] 303565 0
Scores for Aggression on the parent rated BASC-2
Timepoint [3] 303565 0
Post-intervention (primary time point), 6 and 12 months (follow-up).
Secondary outcome [1] 339238 0
Child's neurocognitive test scores on the NEPSY-2 statue subtest measuring inhibitory control
Timepoint [1] 339238 0
Post-intervention, and 6 and 12 months follow-up.
Secondary outcome [2] 339393 0
Child's neurocognitive test scores on NEPSY-2 Comprehension of Instructions; measuring language and working memory
Timepoint [2] 339393 0
Post-intervention and 6 and 12 months follow-up.
Secondary outcome [3] 339394 0
Child neurocognitive test scores on NEPSY-2 Visuomotor precision subtest; measuring fine motor control
Timepoint [3] 339394 0
Post-intervention, and 6 and 12 months follow-up
Secondary outcome [4] 339396 0
Child scores on the Head-Toes-Knees-Shoulders task, a measure of inhibitory control
Timepoint [4] 339396 0
Post-intervention, and 6 and 2 months follow-up
Secondary outcome [5] 339473 0
Scores for Hyperactivity on teacher rated BASC-2
Timepoint [5] 339473 0
Post-intervention, and 6 and 2 months follow-up
Secondary outcome [6] 339474 0
Scores for Attention Problems on teacher rated BASC-2
Timepoint [6] 339474 0
Post-intervention, and 6 and 2 months follow-up
Secondary outcome [7] 339475 0
Scores for Aggression on the teacher rated BASC-2
Timepoint [7] 339475 0
Post-intervention, and 6 and 2 months follow-up

Eligibility
Key inclusion criteria
Families of children aged 3-4 years with T-scores on the BASC-2 of above 60 (i.e., 1 Sd above the mean) for hyperactivity were eligible to participate.
Minimum age
3 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior brain injury, significant developmental disorder, not fluent in English, BASC-2 t-scores of hyperactivity that are below 60.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealed - central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measures ANOVA to assess within and between group differences over time

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9252 0
New Zealand
State/province [1] 9252 0
Dunedin

Funding & Sponsors
Funding source category [1] 297645 0
Government body
Name [1] 297645 0
Health Research Council
Address [1] 297645 0
Level 3, 110 Stanley St, Grafton, Auckland 1010
Country [1] 297645 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 296665 0
None
Name [1] 296665 0
Address [1] 296665 0
Country [1] 296665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298730 0
University of otago Ethics committee
Ethics committee address [1] 298730 0
PO box 56 Dunedin 9054
Ethics committee country [1] 298730 0
New Zealand
Date submitted for ethics approval [1] 298730 0
03/05/2011
Approval date [1] 298730 0
20/05/2011
Ethics approval number [1] 298730 0
# 11/121

Summary
Brief summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is characterised by dysregulation in activity levels, attentional control, and impulse control. It emerges during preschool, often persisting into adulthood. Several effective short-term treatments exist, however, improvements are rarely maintained when treatment ceases. Current treatments involve external regulation of symptoms through medication or behaviour management. Our novel early intervention programme addresses the neurocognitive deficits associated with ADHD and teaches preschool children to self-regulate. Results from our open-label trial showed significant reductions in ADHD symptoms and improvements in brain functioning within areas involved in self-regulation. Importantly, improvements in self-regulation were associated with maintained ADHD symptom reduction up to 12-months post-treatment. The proposed randomised control trial will provide a critical test of our programme against treatment as usual (Triple P - parent training).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78046 0
Dr Dione Healey
Address 78046 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 78046 0
New Zealand
Phone 78046 0
+64 3 4797620
Fax 78046 0
Email 78046 0
dionehealey@psy.otago.ac.nz
Contact person for public queries
Name 78047 0
Dr Dione Healey
Address 78047 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 78047 0
New Zealand
Phone 78047 0
+64 3 4797620
Fax 78047 0
Email 78047 0
dionehealey@psy.otago.ac.nz
Contact person for scientific queries
Name 78048 0
Dr Dione Healey
Address 78048 0
Department of Psychology
University of Otago
PO Box 56
Dunedin
9054
Country 78048 0
New Zealand
Phone 78048 0
+64 3 4797620
Fax 78048 0
Email 78048 0
dionehealey@psy.otago.ac.nz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary