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Trial registered on ANZCTR


Registration number
ACTRN12615000962538
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
14/09/2015
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Date results information initially provided
8/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tuning in to Toddlers (TOTS):
A randomised controlled trial of an emotion-focused program for parents of toddlers
Scientific title
Tuning in to Toddlers (TOTS):
A randomised controlled trial of an emotion-focused program for parents of toddlers to improve parenting and prevent child mental health difficulties
Secondary ID [1] 286414 0
nil
Universal Trial Number (UTN)
Trial acronym
TOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of child internalising and externalising behaviour problems 294580 0
Promotion of parenting skills 294581 0
Condition category
Condition code
Mental Health 294882 294882 0 0
Other mental health disorders
Public Health 296188 296188 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TOTS is a six-session, weekly group program running for 2 hours for parents of toddlers. The program aims to teach parents to assist their young child to understand and manage their emotions. TOTS also provides parents with skills in understanding and managing their own emotions thereby reducing the stress of parenting a young child and improving their mental health. The program is delivered using psychoeducation, role play practice, watching DVD material, group discussion, exercises and home activities. The program is facilitated by program authors who are psychologists or parent educators. The program is delivered using a structured manual with fidelity checklists used to ensure maximum adherence to the program.
Intervention code [1] 291486 0
Prevention
Comparator / control treatment
15 month wait list control group
Control group
Active

Outcomes
Primary outcome [1] 294633 0
Parenting skills: measured using parent self report on questionnaires (at baseline, post intervention and 12 month follow-up) along with observed parenting skills in a structured parent-child assessment at baseline and 12-month follow up.

Self-report parenting using two validated measures:
Parent Emotional Style Questionnaire (PESQ) - 21 items measuring parent emotion-coaching and emotion-dismissing beliefs.
Coping with Toddlers Negative Emotions Scale (CTNES) - 12 hypothetical situations measuring parental behaviours in response to toddler’s emotions; yields 7 sub-scales


Observed parenting: A structured assessment is used with validated coding methods:
Parents and toddlers will enter a room with a camera set up and some toys on the floor. Tasks will include: parent and child share free play with toys (5 mins); a building block activity (5 minutes); parent asks toddler to complete a challenging puzzle while the parent completes a questionnaire (5 mins); parent and child enact a story using a dolls house and family characters (10 mins); pack up the equipment (3 mins). Coding will measure emotion coaching/dismissing, emotional responsiveness and child emotion regulation using coding by Baker, Fenning and Crnic, (2011).
Timepoint [1] 294633 0
The primary outcomes are measured at baseline and 12-months post-intervention (which is approximately 15-months after baseline assessment).
Primary outcome [2] 294634 0
Parent emotion regulation: measured using parent self report on questionnaires (at baseline, post intervention and 12 month follow-up).

The measure used is the Difficulties with Emotion Regulation Scale (DERS) - 41 items on parent’s emotion regulation
Timepoint [2] 294634 0
Measured at baseline and 12-months post-intervention (which is approximately 15-months after baseline assessment).
Secondary outcome [1] 313767 0
Child emotional and behavioural functioning: measured using parent - report on questionnaires (at baseline, post intervention and 12 month follow-up).

The measure used is:
Brief Infant Toddler Social Emotional Assessment (BITSEA) - 34 items measuring toddler’s social and behavioural functioning.
Timepoint [1] 313767 0
Measured at baseline and 12-months post-intervention (which is approximately 15-months after baseline assessment).
Secondary outcome [2] 313768 0
Parent stress cortisol: measured using hair cortisol samples at baseline and 15-months later (12-month follow-up)
Timepoint [2] 313768 0
Measured at baseline and 12-months post-intervention (which is approximately 15-months after baseline assessment).
Secondary outcome [3] 316897 0
Toddler stress cortisol: measured using hair cortisol samples at baseline and 15-months later (12-month follow-up)
Timepoint [3] 316897 0
Measured at baseline and 12-months post-intervention (which is approximately 15-months after baseline assessment).

Eligibility
Key inclusion criteria
parents with a child between 18 months and 36 months of age who attend target childcare centres, maternal child heath centres and playgroups.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficent English language skills to complete questionnaires or attend the parenting program

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)
Allocation is concealed: Childcare/Maternal Child Health Centres/Playgroups are randomised to intervention or control. Participants do not know their condition status when they enrol in the study and are assigned their condition (intervention/control) once they complete Time 1 assessment. Randomisation is generated using a computer assisted program (Research Randomizer) which is undertaken by Dr Havighurst who is located in a different building than the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Research Randomizer is a computer generated software program that is used to generate a list of numbers that are then allocated to the centres.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster randomisation is used not individual randomisation. Centres are randomised into intervention or wait-list control. This means those in the intervention receive the intervention immediately and then follow-up assessment. Wait list control participants complete all assessment and after the last follow-up measures (15-months after baseline) they receive the intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size requirements and power calculation:
Using methods proposed by Eldridge et al. (2006) the estimated design effect for the study is 1.30 (based on 40 clusters of average size 7, a coefficient of variation for cluster size of 0.25, and a conservative at worst intra-class correlation of 0.05). The following power calculation incorporates this estimated design effect from clustering, and is done for feasible differential treatment effects at 15 months follow-up, where attrition will be highest. The treatment effect difference is conservatively estimated to result in group differences of about 0.40 SDs for continuous outcome measures. To achieve 80% power at a 5% significance level, the required sample size at follow-up needs to be 100×1.30 = 130 participants in each condition. Based on other studies that we have conducted, including our pilot study, we estimate there will be 10% attrition. This implies that 130/0.90 =144 participants are needed in each condition for the study to have sufficient power.

Recruitment and uptake rate:
We assume an 10% recruitment rate from all parents canvassed and a 90% uptake rate from parents who indicate an interest in being involved in the study, we will require initial recruitment of 288 / (0.85*0.90) = 376 participants in the 40-60 centres (i.e., approximately 9 parents on average per centre) to achieve a final baseline sample size of 288. This number was rounded up to 290 for ease with recruitment.

Once data are collected Multi-level modelling will be used to determine outcome differences.

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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291446 0
Charities/Societies/Foundations
Name [1] 291446 0
Australian Rotary Health
Address [1] 291446 0
PO Box 3455 Parramatta NSW 2124
Country [1] 291446 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
MIndful, Building C, 50 Flemington Street, Flemington, VIC 3031
Country
Australia
Secondary sponsor category [1] 290121 0
None
Name [1] 290121 0
Address [1] 290121 0
Country [1] 290121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292997 0
University of Melbourne Health Sciences Human Ethics Committee
Ethics committee address [1] 292997 0
Office for Research Ethics and Integrity
Research, Innovation and & Commercialisation
The University of Melbourne
Incorporating UoM Commercial Ltd and the School of Melbourne Custom Programs
Level 1, 780 Elizabeth Street
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [1] 292997 0
Australia
Date submitted for ethics approval [1] 292997 0
Approval date [1] 292997 0
23/01/2015
Ethics approval number [1] 292997 0
1443496

Summary
Brief summary
This research will evaluate a new parenting program, Tuning in to Toddlers (TOTS), an intervention with goals to prevent the onset of social, emotional and behavioural difficulties in young children. TOTS aims to improve parents’ emotional responsiveness and emotion regulation in order to assist their child to begin to understand and regulate their emotional reactions and to reduce stress for parent and child. There are few available evidence based programs for parents of toddlers and none have taken an emotion-focused approach despite early childhood being a time of intense emotions for parents and a critical time in toddler’s emotional development. TOTS will focus on and promote emotional competencies, strengthening the parent-child relationship that will reduce the likelihood of child emotional or behavioural problems during these early years.

The study will recruit 290 parents of a 2-3 year old child through maternal and child health centres, Playgroups Victoria and childcare services in Melbourne. Participants will be randomised to either TOTS or a wait-list control group. TOTS participants will attend a 6-session parenting program while wait-list participants will be offered the program after a 15-month waiting period (unless they require clinical intervention). Participants will complete measures at baseline, immediately post- intervention (intervention participants only) and at 15-month follow-up. To assess the efficacy of TOTS we will use well validated measures including questionnaires about parenting and children’s functioning; a parent-toddler observation task measuring parental emotion coaching, parental emotional responsiveness and toddler emotion regulation; and hair samples to assess parent and toddler stress levels. TOTS is a manualised intervention and measures will be used to determine program acceptability and fidelity. Statistical analyses will compare participants in the two groups at follow-up. Outcomes will be reported in peer-reviewed journals, at conferences and in a facilitator manual of TOTS that will enable program dissemination.
Trial website
www.tuningintokids.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56046 0
Dr Sophie Havighurst
Address 56046 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Flemington VIC 3031
Country 56046 0
Australia
Phone 56046 0
+61393710202
Fax 56046 0
+61393710250
Email 56046 0
sophie.h@unimelb.edu.au
Contact person for public queries
Name 56047 0
Dr Sophie Havighurst
Address 56047 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Flemington VIC 3031
Country 56047 0
Australia
Phone 56047 0
+61393710202
Fax 56047 0
+61393710250
Email 56047 0
sophie.h@unimelb.edu.au
Contact person for scientific queries
Name 56048 0
Dr Sophie Havighurst
Address 56048 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Flemington VIC 3031
Country 56048 0
Australia
Phone 56048 0
+61393710202
Fax 56048 0
+61393710250
Email 56048 0
sophie.h@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data is not available outside of the study investigators. Consent was not sought from participants for data sharing.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Final results for this study are still being written up. In sum, significant changes were found for intervention participants but not control participants for most aspects of parenting, for child behaviour and for systemic cortisol stress in toddlers.