Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000452594
Ethics application status
Approved
Date submitted
17/10/2006
Date registered
19/10/2006
Date last updated
19/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tuning in to Kids
Scientific title
Tuning in to Kids: A parent and teacher intervention for promoting preschoolers emotional competence and reducing behaviour problems
Universal Trial Number (UTN)
Trial acronym
TIK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parents' Emotional Competence 1425 0
Children's Emotional Competence and Behaviour Problems 1426 0
Condition category
Condition code
Mental Health 1522 1522 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is six weekly two hour parenting group sessions followed by two booster sessions at two month intervals. Parents learn skills in emotion coaching of the child and emotion regulation for themselves.
Teachers learn basic skills in emotion coaching in a single two hour
group session.
Intervention code [1] 1407 0
Behaviour
Comparator / control treatment
Waitlist controls
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2101 0
For parents:
1) Increased emotional awareness, acceptance and coaching of children's emotions
Timepoint [1] 2101 0
Pre-intervention, immediately following the parenting program, and six months follow-up
Primary outcome [2] 2102 0
For parents:
2) Improved emotion awareness of regulation in parent
Timepoint [2] 2102 0
Pre-intervention, immediately following the parenting program, and six months follow-up
Primary outcome [3] 2103 0
For children:
1) Improved emotion regulation, emotional understanding
Timepoint [3] 2103 0
Rated by parents: pre-intervention, immediately following the parenting program, and six months follow-up; also rated by observer pre-intervention and 6 months follow-up. Also rated by teacher pre-intervention and approximately 9 months later, coinciding with 6 months follow-up.
Primary outcome [4] 2104 0
For children:
2) Reduced behaviour problems, decreased negative emotionality
Timepoint [4] 2104 0
Rated by parents: pre-intervention, immediately following the parenting program, and six months follow-up; also rated by observer pre-intervention and 6 months follow-up. Also rated by teacher pre-intervention and approximately 9 months later, coinciding with 6 months follow-up.
Secondary outcome [1] 3645 0
Parents: Improved mental health
Timepoint [1] 3645 0
Measured pre-intervention, immediately following the parenting program and six months follow up.
Secondary outcome [2] 3646 0
Family: Improved emotional expressiveness in family
Timepoint [2] 3646 0
Measured pre-intervention, immediately following the parenting program and six months follow up.

Eligibility
Key inclusion criteria
Primary carer with children who have had their fourth birthday and have not yet turned six at the time of recruitment were included.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents without sufficient English language skills to answer questionnaires and understand the program content were excluded.Children with a primary diagnosis of a communication or Pervasive Developmental Disorder were excluded.

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)
Central randomisation by statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation clusters (community sample) and research randomiser for clinical sample
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Data collected pre-intervention (parent questionnaires, teacher questionnaires, home observations), post intervention (parent questionnaires), and after 6 months follow-up (parent questionnaires, teacher questionnaires, home observations). Control group receive intervention after 9 months wait.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1658 0
Charities/Societies/Foundations
Name [1] 1658 0
Rotary Australia
Country [1] 1658 0
Australia
Funding source category [2] 1659 0
Charities/Societies/Foundations
Name [2] 1659 0
Financial Markets/Foundation for Children
Country [2] 1659 0
Australia
Funding source category [3] 1660 0
Charities/Societies/Foundations
Name [3] 1660 0
William Buckland Foundation
Country [3] 1660 0
Australia
Primary sponsor type
Name
Rotary Australia; Financial Markets/Foundation for Children; William Buckland Foundation
Address
Country
Australia
Secondary sponsor category [1] 1465 0
University
Name [1] 1465 0
Melbourne University
Address [1] 1465 0
Country [1] 1465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3104 0
Melbourne University Human Research Ethics Committee
Ethics committee address [1] 3104 0
Ethics committee country [1] 3104 0
Australia
Date submitted for ethics approval [1] 3104 0
Approval date [1] 3104 0
06/03/2006
Ethics approval number [1] 3104 0
050890
Ethics committee name [2] 3105 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [2] 3105 0
Ethics committee country [2] 3105 0
Australia
Date submitted for ethics approval [2] 3105 0
Approval date [2] 3105 0
28/03/2006
Ethics approval number [2] 3105 0
039345 5522

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27341 0
Address 27341 0
Country 27341 0
Phone 27341 0
Fax 27341 0
Email 27341 0
Contact person for public queries
Name 10596 0
Dr Sophie Havighurst
Address 10596 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building 36
Austin Repatriation Hospital
Heidelberg Melbourne VIC 3084
Country 10596 0
Australia
Phone 10596 0
+61 3 94964150
Fax 10596 0
+61 3 94999120
Email 10596 0
Sophie.h@unimelb.edu.au
Contact person for scientific queries
Name 1524 0
Dr Sophie Havighurst
Address 1524 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building 36
Austin Repatriation Hospital
Heidelberg Melbourne VIC 3084
Country 1524 0
Australia
Phone 1524 0
+61 3 94964150
Fax 1524 0
+61 3 94999120
Email 1524 0
Sophie.h@unimelb.edu.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.