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Trial registered on ANZCTR


Registration number
ACTRN12618000310268
Ethics application status
Approved
Date submitted
4/02/2018
Date registered
1/03/2018
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning in to Kids: Comparing three methods of delivery of a program to parents of children with behaviour difficulties
Scientific title
Tuning in to Kids: Comparing three methods of delivery of an emotion-focused parenting program for parents of 3-10 year old children with behaviour problem aimed at improving children’s behaviour and emotional functioning
Secondary ID [1] 293345 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of child externalising behaviour problems 305448 0
Promotion of parenting skills 305485 0
Condition category
Condition code
Mental Health 304720 304720 0 0
Other mental health disorders
Public Health 304741 304741 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be receiving one of three alternative modes of an evidence-based parenting program developed for parents of children with emerging conduct/behavioral problems and compared to wait list control participants, Tuning in to Kids (TIK). TIK is a parenting program that teaches parents how to respond to their child's emotions that build's the child's emotional competence. TIK teaches parents to be aware of and regulation their own emotions, as well as help their children learn to understand and manage their emotions. Development of these skills in parents and children are anticipated to improve the social, emotional and behavioural functioning of children and improve parental mental health. TIK is delivered in different modes including in a group, one to one with a therapist, or in an online program. The group/1:1 delivery is in eight sessions, with each session focusing on a different aspect of parenting through psychoeducation, role plays, an exploration of parents own family of origin, and an exploration of how parents typically respond to their child's emotions and the outcomes associated with this. One trained facilitator will conduct eight sessions of TIK (for the group and 1:1 conditions). The online version will be self-directed and delivered in ten different modules containing psychoeducation, demonstration role plays and exercises for parents to complete.

Materials: TIK uses a structured session manual for the facilitator/therapist to deliver all information relevant to the program that includes worksheets for parents to use both during the program and at home.

Delivery: The interventions will be delivered by facilitators trained in the TIK program. All facilitators will have a minimum of a Bachelors degree majoring in Psychology, and will have either completed or be in the process of completing post-gradate studies in Psychology (either a Masters, PhD, or Clinical Doctorate). The online program has been made by the program developers and is delivered in 10 chapters explaining the main ideas and providing exercises for parents to use.

Arm 1: Parents will participate in a structured manualised group version of TIK (consisting of 8-10 parents). Parents will attend eight, 2-hour weekly sessions.
Arm 2: Parents will participate in 8 X 1 hour weekly sessions of a structured manualised one to one delivery version of TIK.
Arm 3: Parents will participate in an online version of TIK consisting of 10 modules of approximately 15 minutes each and a total of 2 and 1/2 hours of viewing over up to 8 weeks. Exercises are provided for parents to try out the skills with their children. Parents are encouraged to watch 1-2 modules in a single sitting on a weekly basis but progress will be at the discretion of the participant. in order to monitor program adherence, website analytics will be used to capture data on program use both in terms of when modules were watched and whether they were completed. Two follow-up phone calls will be administered, the first 2 weeks after session 1 is watched, and the second on program completion or at 4 weeks after time 1.
Arm 4: Parents will be in a waitlist control condition
Intervention code [1] 299597 0
Prevention
Comparator / control treatment
Participants in the waitlist-control condition will wait for 9 months before receiving the online intervention.
Control group
Active

Outcomes
Primary outcome [1] 303923 0
Children's Behaviour (measured using parent and teacher report on the Eyberg Child Behaviour Inventory)
Timepoint [1] 303923 0
Immediately pre-intervention, immediately following the intervention, 6 months post-intervention completion (primary endpoint).
Primary outcome [2] 303924 0
Children's Emotional Competence (measured using the Kusche Affective Interview, the HOME Interview with Child, and the Emotion Regulation Checklist)
Timepoint [2] 303924 0
Immediately pre-intervention and 6 months post-intervention completion
Secondary outcome [1] 340474 0
Parents emotion socialisation (measured with parent report on the Coping with Children's Negative Emotions Scale and the Parent Emotional Style Questionnaire, as well as through parent-child observation on the Emotion Discussion Task)
Timepoint [1] 340474 0
Immediately pre-intervention and 6 months post-intervention completion
Secondary outcome [2] 340475 0
Parent emotion regulation (measured using parent report on Difficulties with Emotion Regulation Scale)
Timepoint [2] 340475 0
Immediately pre-intervention and 6 months post-intervention completion
Secondary outcome [3] 340476 0
Parents report on family functioning (measured by the Abbreviated Dyadic Adjustment Scale, the Family Conflict Scale, and the Co-parenting relationship scale)
Timepoint [3] 340476 0
Immediately pre-intervention and 6 months post-intervention completion
Secondary outcome [4] 340538 0
Parental Reflective Functioning (as measured by the Parental Reflective Functioning Questionnaire)
Timepoint [4] 340538 0
Immediately pre-intervention and 6 months post-intervention completion
Secondary outcome [5] 342759 0
Parental warmth and hostility (as measured by items from Longitudinal Study for Australian Children
Timepoint [5] 342759 0
Immediately pre-intervention and 6 months post-intervention completion

Eligibility
Key inclusion criteria
Inclusion criteria will be that the parent has a child aged between 3 and 10 years of age, and that they perceive that child as having behaviour problems.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include whether the child has a known Intellectual Disability, a Pervasive Developmental Disorder, a severe Communication Disorder, or if the parent has insufficient English language to participate in the intervention and complete questionnaires. Referral for appropriate intervention would be made for these children and families to CAMHS/CYMHS or other local community agencies.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by 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
Baseline data will be used to examine relationships between parent- and teacher-reported and direct assessment information. Post-intervention data will be used to examine content fidelity, process fidelity and participant/facilitator responsiveness as well as immediate post-intervention changes for those in the three intervention conditions. ANCOVA, Linear Mixed-Effects Modelling in SPSS and Latent Growth Modeling will be used to assess how individuals in each condition change over time and whether they are significantly different from each other at each time point, taking into account differences at baseline and missing data at follow-up. In particular we will examine differences between the conditions (mostly between two separate conditions at a time such as TIK-Online versus control) to determine whether ANCOVA results yield timexcondition differences at the p < .05. Using G-power, we anticipate that we will achieve medium to large effect sizes (based on our previous trials of the program with clinical samples) in the primary and secondary outcome variables, with power set at .80 and type 1 error set at 0.5, a sample size of 187 is required to conduct ANCOVA analyses where intervention and control participants are compared.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
1/03/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
400
Accrual to date
139
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18073 0
3032 - Travancore
Recruitment postcode(s) [2] 18074 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 297965 0
University
Name [1] 297965 0
University of Melbourne
Country [1] 297965 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Mindful
Department of Psychiatry
Building C
50 Flemington Street
Travancore 3032
VIC
Melbourne
Country
Australia
Secondary sponsor category [1] 297741 0
University
Name [1] 297741 0
Swinburne University
Address [1] 297741 0
Department of Psychology
Level 4,
George Swinburne BuildingJohn Street,
Hawthorn
Victoria 3122
Country [1] 297741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299007 0
University of Melbourne
Ethics committee address [1] 299007 0
Ethics committee country [1] 299007 0
Australia
Date submitted for ethics approval [1] 299007 0
01/10/2017
Approval date [1] 299007 0
30/10/2017
Ethics approval number [1] 299007 0
1750231

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

Contacts
Principal investigator
Name 78978 0
A/Prof Sophie Havighurst
Address 78978 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 78978 0
Australia
Phone 78978 0
+61 3 93710202
Fax 78978 0
+61 3 93710250
Email 78978 0
sophie.h@unimelb.edu.au
Contact person for public queries
Name 78979 0
Sophie Havighurst
Address 78979 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 78979 0
Australia
Phone 78979 0
+61 3 93710202
Fax 78979 0
+61 3 93710250
Email 78979 0
sophie.h@unimelb.edu.au
Contact person for scientific queries
Name 78980 0
Sophie Havighurst
Address 78980 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 78980 0
Australia
Phone 78980 0
+61 3 93710207
Fax 78980 0
+61 3 93710250
Email 78980 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 was provided without consent for public use.


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
SourceTitleYear of PublicationDOI
EmbaseA randomised-controlled pilot study of the one-to-one delivery of Tuning in to Kids: impact on emotion socialisation, reflective functioning, and childhood behaviour problems.2021https://dx.doi.org/10.1080/13632752.2021.1984208
Dimensions AIAlternatives of municipal solid wastes to energy for sustainable development. The case of Barranquilla (Colombia)2021https://doi.org/10.1080/19397038.2021.1993378
N.B. These documents automatically identified may not have been verified by the study sponsor.