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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
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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
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Secondary ID [1]
293345
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention of child externalising behaviour problems
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Promotion of parenting skills
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Condition category
Condition code
Mental Health
304720
304720
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0
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Other mental health disorders
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Public Health
304741
304741
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
299597
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Prevention
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Comparator / control treatment
Participants in the waitlist-control condition will wait for 9 months before receiving the online intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Children's Behaviour (measured using parent and teacher report on the Eyberg Child Behaviour Inventory)
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Assessment method [1]
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Timepoint [1]
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Immediately pre-intervention, immediately following the intervention, 6 months post-intervention completion (primary endpoint).
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Primary outcome [2]
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Children's Emotional Competence (measured using the Kusche Affective Interview, the HOME Interview with Child, and the Emotion Regulation Checklist)
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Assessment method [2]
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Timepoint [2]
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Immediately pre-intervention and 6 months post-intervention completion
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Secondary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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Immediately pre-intervention and 6 months post-intervention completion
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Secondary outcome [2]
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Parent emotion regulation (measured using parent report on Difficulties with Emotion Regulation Scale)
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Assessment method [2]
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Timepoint [2]
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Immediately pre-intervention and 6 months post-intervention completion
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Secondary outcome [3]
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Parents report on family functioning (measured by the Abbreviated Dyadic Adjustment Scale, the Family Conflict Scale, and the Co-parenting relationship scale)
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Assessment method [3]
340476
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Timepoint [3]
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Immediately pre-intervention and 6 months post-intervention completion
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Secondary outcome [4]
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Parental Reflective Functioning (as measured by the Parental Reflective Functioning Questionnaire)
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Assessment method [4]
340538
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Timepoint [4]
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Immediately pre-intervention and 6 months post-intervention completion
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Secondary outcome [5]
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Parental warmth and hostility (as measured by items from Longitudinal Study for Australian Children
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Assessment method [5]
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Timepoint [5]
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Immediately pre-intervention and 6 months post-intervention completion
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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.
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Minimum age
3
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2018
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Actual
1/03/2018
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Date of last participant enrolment
Anticipated
31/12/2019
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Actual
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Date of last data collection
Anticipated
31/12/2020
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Actual
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Sample size
Target
400
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Accrual to date
139
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
18073
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3032 - Travancore
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Recruitment postcode(s) [2]
18074
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3122 - Hawthorn
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Melbourne
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Address [1]
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Mindful
Building C
50 Flemington Street
Travancore 3032
VIC
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Country [1]
297965
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
Mindful
Department of Psychiatry
Building C
50 Flemington Street
Travancore 3032
VIC
Melbourne
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Swinburne University
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Address [1]
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Department of Psychology
Level 4,
George Swinburne BuildingJohn Street,
Hawthorn
Victoria 3122
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Country [1]
297741
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299007
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University of Melbourne
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Ethics committee address [1]
299007
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Human Ethics Committee Alan Gilbert Building Grattan Street Melbourne 3010 VIC
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Ethics committee country [1]
299007
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Australia
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Date submitted for ethics approval [1]
299007
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01/10/2017
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Approval date [1]
299007
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30/10/2017
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Ethics approval number [1]
299007
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1750231
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Summary
Brief summary
Tuning in to Kids is an evidence based program teaching parents skills in emotion coaching where they assist their child to learn about and manage their emotions. Parents also learn to develop their own skills with regulating their emotions. This trial will test out different forms of the program for parents of children with challenging behaviours relative to control participants. A) Aims and Objectives This study will evaluate the effectiveness of three delivery methods (one-to-one, group, online) of an emotion-focused parenting program, Tuning in to Kids (TIK) compared to control with parents of 3-10 year-old children with behaviour problems. There three aims include: • Examine whether the different interventions (relative to control) improve parenting and children’s emotional, social and behavioural functioning. • To examine for whom the program works (moderators) of program outcomes in order to establish which families do best with which intervention delivery method. • To establish the evidence for three different methods of TIK delivery and making this knowledge available to professionals working with families of children with behaviour problems. B) Key Question(s) Key questions are whether the three different versions of TIK are effective in comparison to control and whether any one program is more effective. Specific hypotheses are that at 6-month follow-up, participants in the three intervention conditions (but not the control) will have: • Improved parenting (emotion socialisation, parental sensitivity, warmth, hostility/criticism), via parent self-report and direct observation of parent-child interaction; • Improved parent functioning (emotion regulation and mental health) on parent self-report; • Improved child emotional knowledge and reduced behaviour problems, measured via direct assessment and parent- and teacher-report. C) Research Design The study will use a randomised controlled design with 400 parents of 3-10 year-old children with behaviour problems, randomised into four conditions (one-to-one, group, online delivery, and waitlist control). Measurement will be taken before, immediately after and 6 months after parents participate in a parenting program. Measures include parent and teacher report plus assessment of the child and observation of the parent and child. The Tuning in to Kids program will teach parents how to emotion coach their children in order to improve children's emotional understanding and regulation. D) Analyses and Outcomes Analyses will be conducted with the data to see for whom the program works and on which factors there are changes. Findings will be reported in peer review journals and at conferences. A summary of findings will also be given to all participants.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Sophie Havighurst
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Address
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Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
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Country
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Australia
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Phone
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+61 3 93710202
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Fax
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+61 3 93710250
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Email
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[email protected]
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Contact person for public queries
Name
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Sophie Havighurst
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Address
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Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
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Country
78979
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Australia
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Phone
78979
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+61 3 93710202
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Fax
78979
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+61 3 93710250
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Email
78979
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[email protected]
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Contact person for scientific queries
Name
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Sophie Havighurst
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Address
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Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
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Country
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Australia
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Phone
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+61 3 93710207
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Fax
78980
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+61 3 93710250
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This data was provided without consent for public use.
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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
Source
Title
Year of Publication
DOI
Embase
A 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.
2021
https://dx.doi.org/10.1080/13632752.2021.1984208
Dimensions AI
Alternatives of municipal solid wastes to energy for sustainable development. The case of Barranquilla (Colombia)
2021
https://doi.org/10.1080/19397038.2021.1993378
N.B. These documents automatically identified may not have been verified by the study sponsor.
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