Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000620921
Ethics application status
Approved
Date submitted
16/06/2011
Date registered
16/06/2011
Date last updated
4/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
"Tuning in to Kids" for Parents of Children with Chronic Illness
Scientific title
The efficacy of an emotion-focused parenting program, "Tuning in to Kids", on parenting styles, emotional competence and mental health in parents of school-aged children with chronic illness compared to a control group.
Secondary ID [1] 262393 0
Nil
Universal Trial Number (UTN)
U1111-1121-2171
Trial acronym
TIK Chronic Illness
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parents' Emotional Competence 268096 0
Parents' Mental Health 268097 0
Children's Emotional Competence 268098 0
Children's Behavioural Problems 268099 0
Chronic Illness in Children 268101 0
Condition category
Condition code
Mental Health 268240 268240 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 268241 268241 0 0
Depression
Mental Health 268242 268242 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 6 session 2-hour weekly parenting program based on emotional intelligence. Parents learn skills to emotion coach their child as well as regulate their own emotions. It will be compared to a control group.
Intervention code [1] 266781 0
Behaviour
Intervention code [2] 266782 0
Prevention
Intervention code [3] 266783 0
Treatment: Other
Comparator / control treatment
The control group will continue to receive treatment as usual as part of their standard care at the RCH.
Control group
Active

Outcomes
Primary outcome [1] 268972 0
Parents' parenting style (increased emotion coaching and parental acceptance of negative emotion, decreased parental rejection of negative emotion from the Emotion-Related Parenting Styles, ERPS)
Timepoint [1] 268972 0
Pre- and post-intervention, 3 months follow-up
Primary outcome [2] 268973 0
Parents' emotional health (% with below clinical score in Depression, Anxiety and Stress Scale, DASS)
Timepoint [2] 268973 0
Pre- and post-intervention, 3 months follow-up
Primary outcome [3] 268974 0
Parents' emotional regulation (increased awareness and regulation on the Difficulties in Emotional Regulation Scale, DERS)
Timepoint [3] 268974 0
Pre- and post-intervention, 3 months follow-up
Secondary outcome [1] 276731 0
Children behavioural problems (% with non-clinical score for Internalizing and Externalizing problems on Child Behavior Checklist, CBCL)
Timepoint [1] 276731 0
Pre- and post-intervention, 3 months follow-up
Secondary outcome [2] 276732 0
Children's emotional awareness (increase in the awareness and recognition based on the Emotional Awareness Questionnaire, EAQ)
Timepoint [2] 276732 0
Pre- and post-intervention, 3 months follow-up
Secondary outcome [3] 276733 0
Parenting Competence (increase satisfaction and perceived efficacy on the Parent Sense of Competence Scale, PSOC)
Timepoint [3] 276733 0
Pre- and post-intervention, 3 months follow-up

Eligibility
Key inclusion criteria
Parent of a school-aged child between the age of 5 and 11 years old who has been diagnosed with a chronic illness for more than a year and currently receiving out-patient treatment at the RCH.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents without sufficient English language skills to answer questionnaires and understand parenting program content.
Children with a primary diagnosis of communication disorder or intellectual disability.

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Participants followed up for 6months from their first data collection.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
26/10/2012
Date of last participant enrolment
Anticipated
Actual
15/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2295 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 267257 0
University
Name [1] 267257 0
Psychological Sciences, The University of Melbourne
Country [1] 267257 0
Australia
Funding source category [2] 267258 0
University
Name [2] 267258 0
Mindful - Centre for Research and Training in Developmental Health, The University of Melbourne
Country [2] 267258 0
Australia
Funding source category [3] 267259 0
Self funded/Unfunded
Name [3] 267259 0
Wai Wai Yang
Country [3] 267259 0
Australia
Funding source category [4] 289040 0
Charities/Societies/Foundations
Name [4] 289040 0
Surgical Research Group
Country [4] 289040 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Parkville 3010 VIC
Country
Australia
Secondary sponsor category [1] 266321 0
None
Name [1] 266321 0
Address [1] 266321 0
Country [1] 266321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269246 0
The Royal Children's Hospital Human Research Ethics Commitee
Ethics committee address [1] 269246 0
Ethics committee country [1] 269246 0
Australia
Date submitted for ethics approval [1] 269246 0
24/06/2011
Approval date [1] 269246 0
29/11/2011
Ethics approval number [1] 269246 0
31201

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

Contacts
Principal investigator
Name 32751 0
Dr Sophie Havighurst
Address 32751 0
Mindful – Centre for Training and Research in Developmental Health, Building C, 50 Flemington Street, Flemington 3031 VIC
Country 32751 0
Australia
Phone 32751 0
+61393710202
Fax 32751 0
Email 32751 0
[email protected]
Contact person for public queries
Name 15998 0
Wai Wai Yang
Address 15998 0
Mindful – Centre for Training and Research in Developmental Health, Building C, 50 Flemington Street, Flemington 3031 VIC
Country 15998 0
Australia
Phone 15998 0
+61393710211
Fax 15998 0
Email 15998 0
[email protected]
Contact person for scientific queries
Name 6926 0
Sophie Havighurst
Address 6926 0
Mindful – Centre for Training and Research in Developmental Health, Building C, 50 Flemington Street, Flemington 3031 VIC
Country 6926 0
Australia
Phone 6926 0
+61 3 9371 0202
Fax 6926 0
Email 6926 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.