Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000504213
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
6/04/2018
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning in to Kids Together: Exploring a parenting program designed for parents raising children together with the focus of improving children's emotions and behaviours.
Scientific title
Tuning in to Kids Together: A preliminary trial of a co-parent, emotion-focused parenting program for parents of 3 - 10 year old children aimed at improving children's emotional and behavioural functioning.
Secondary ID [1] 294361 0
None
Universal Trial Number (UTN)
Trial acronym
TIK-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of child internalising and externalising behaviour problems 307083 0
Promotion of parenting skills
 307084 0
Condition category
Condition code
Public Health 306192 306192 0 0
Health promotion/education
Mental Health 306193 306193 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tuning into Kids Together (TIK-T) is a modified version of the evidence-based Tuning in to Kids parenting program. TIK-T is a parenting program that teaches parents how to respond to their children's emotions and consequently foster children’s emotional competence. This specific aspect of parenting related to parents' emotion socialisation practices. That is, how parents respond, discuss, and teach their children about emotions.

Parents are taught to become aware of their own emotions, as well as how they can help their children learn to understand and manage their emotions. TIK-T also provides co-parents with the opportunity to explore how they work together to support their child’s emotional development. It is expected that the program will result in improved emotional and behavioural functioning of children, increased emotional responsiveness in parents, and improved co-parenting functioning. The TIK-T is a group parenting-parenting program that consists of eight x two-hour sessions that run over eight weeks. Each session explores different aspect of parenting via psychoeducation, role plays, watching DVD material, group discussion, exercises and home activities. New content and activities have been included into TIK-T to address co-parenting.

Materials: TIK-T uses a structured session manual which facilitators will follow when delivering the program. The structured manual ensures the parents are provided with all relevant information. Parents will be provided with booklets which contain worksheets, extra information, as well as in-class and at home activities. These extra materials will be designed specifically for this study.

Delivery: The interventions will be delivered by facilitators who are familiar with the TIK program. Facilitators may be working at community and family support services. The experience of the facilitators will vary; however, is it expect that all facilitators will have completed Tuning in to Kids training and/or have experience delivering parenting programs.

Fidelity: Facilitators will be provided with fidelity checklists (one checklist per session). Facilitators will be asked to complete the checklist at the end of each session.

Parent adherence: Facilitators will be asked to complete session attendance lists at the end of each sessions. Parents who do not attend the first session or miss two consecutive sessions will be called by the primary researcher/facilitator. These phone call will enable parents to be provided with a re-cap of program materials and will involve a discussion on barriers which are influencing parents' attendance.
Intervention code [1] 300662 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305202 0
Children's emotional competence (measured using parent and teacher reports of the Emotion Regulation Checklist)
Timepoint [1] 305202 0
Parents: immediately pre-intervention, immediately following the intervention, 6 months post-intervention completion (primary endpoint).

Teachers: immediately pre-intervention, 6 months post-intervention completion (primary endpoint).
Primary outcome [2] 305203 0
Children's behaviour functioning (measured using reports from the parents and teachers on the Strengths and Difficulties Questionnaire)
Timepoint [2] 305203 0
Parent: immediately pre-intervention, immediately following the intervention, 6 months post-intervention completion (primary endpoint)..

Teacher: immediately pre-intervention, 6 months post-intervention completion (primary endpoint).
Secondary outcome [1] 344491 0
Parents emotion socialisation (measured with parent report on the Coping with Children's Negative Emotions Scale and the Parent Emotional Style Questionnaire).
Timepoint [1] 344491 0
Immediately pre-intervention, immediately post-intervention (equivalent two months after allocation for wait-list control), and 6 months post-intervention completion (equivalent eight months after allocation for wait-list control). Wait-list control parents will also complete an additional timepoint upon completing the intervention.

Secondary outcome [2] 344492 0
Parent emotion regulation (measured using parent report on Difficulties with Emotion Regulation Scale)
Timepoint [2] 344492 0
Immediately pre-intervention, immediately post-intervention (equivalent two months after allocation for wait-list control), and 6 months post-intervention completion (equivalent eight months after allocation for wait-list control). Wait-list control parents will also complete an additional timepoint upon completing the intervention.

Secondary outcome [3] 344493 0
Co-parenting functioning (parent reports on the Dyadic Coping Inventory, Coparenting Relationship Scale, Coparenting of Emotion Scale).
Timepoint [3] 344493 0
Immediately pre-intervention, immediately post-intervention (equivalent two months after allocation for wait-list control), and 6 months post-intervention completion (equivalent eight months after allocation for wait-list control). Wait-list control parents will also complete an additional timepoint upon completing the intervention.
Secondary outcome [4] 344494 0
Program feasibility - barriers and enablers for parent engagement and program delivery (measured via custom designed surveys, phone interviews and check-in phone calls).
Timepoint [4] 344494 0
Surveys and phone interviews will be completed post-intervention by parents and facilitators.
Check-in phone calls will be made to parents when they miss the first session or two consecutive sessions.

Eligibility
Key inclusion criteria
Inclusion criteria: co-parents who are raising a child aged between 3 and 10 years of age together and are both able to attend the parenting program together.
Minimum age
18 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 complete questionnaires and engage in the parenting program.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of repeated-measures analysis of variance (ANOVA) will be conducted to compare participants' pre, post, follow-up scores on the following variables: coparenting relationship, parent emotion socialisation practices, parent emotion regulation, child emotional functioning, and child behaviour problems. Using G-power, it is expected that a medium effect size would be achieved for the primary and secondary outcome variables, with power set at .80 and type 1 error set at 0.5, a sample size of 96 is required to conduct repeated-measures ANOVA analyses. In line with previous research, it is expected that there will be an approximate 20-25% attrition rate at follow-up, therefore a total sample of approximately 120 will initially be recruited.

Descriptive statistics and thematic analysis will be used to explore factors that impeded and facilitated parent engagement and program delivery . The following thematic analysis steps will be included: 1) familiarisation 2) generating initial codes- 3) searching for themes 4) reviewing potential themes 5) defining and naming 6) producing the report (Clarke & Braun, 2006).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
27/04/2018
Date of last participant enrolment
Anticipated
24/07/2019
Actual
Date of last data collection
Anticipated
30/03/2020
Actual
Sample size
Target
120
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment postcode(s) [1] 22081 0
3101 - Kew
Recruitment postcode(s) [2] 22082 0
3550 - Bendigo
Recruitment postcode(s) [3] 22083 0
3220 - Geelong
Recruitment postcode(s) [4] 22084 0
3060 - Fawkner
Recruitment postcode(s) [5] 22085 0
3047 - Broadmeadows
Recruitment postcode(s) [6] 26224 0
2114 - West Ryde
Recruitment postcode(s) [7] 26225 0
2131 - Ashfield
Recruitment postcode(s) [8] 26226 0
6053 - Bayswater
Recruitment postcode(s) [9] 26227 0
2206 - Earlwood
Recruitment postcode(s) [10] 26228 0
6163 - Coolbellup

Funding & Sponsors
Funding source category [1] 299002 0
University
Name [1] 299002 0
University
Country [1] 299002 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
Magill Campus - Department of Psychology, Social Work, and Social Policy
St Bernards Road,
Magill SA 5072
Country
Australia
Secondary sponsor category [1] 298226 0
University
Name [1] 298226 0
University of Melbourne
Address [1] 298226 0
Mindful - Building C
Department of Psychiatry
50 Flemington Street
Travancore VIC 3032
Country [1] 298226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299931 0
University of South Australian Human Research Ethics Committee
Ethics committee address [1] 299931 0
Ethics committee country [1] 299931 0
Australia
Date submitted for ethics approval [1] 299931 0
15/08/2017
Approval date [1] 299931 0
28/11/2017
Ethics approval number [1] 299931 0
200349

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

Contacts
Principal investigator
Name 82026 0
Ms Christina Ambrosi
Address 82026 0
University of South Australia
Magill Campus - School of Psychology, Social Work, and Social Policy
St Bernard's Road
Magill SA 5072
Country 82026 0
Australia
Phone 82026 0
+61 03 9371 0213
Fax 82026 0
Email 82026 0
[email protected]
Contact person for public queries
Name 82027 0
Christina Ambrosi
Address 82027 0
University of South Australia
Magill Campus - School of Psychology, Social Work, and Social Policy
St Bernard's Road
Magill SA 5072
Country 82027 0
Australia
Phone 82027 0
+61 03 9371 0213
Fax 82027 0
Email 82027 0
[email protected]
Contact person for scientific queries
Name 82028 0
Christina Ambrosi
Address 82028 0
University of South Australia
Magill Campus - School of Psychology, Social Work, and Social Policy
St Bernard's Road
Magill SA 5072
Country 82028 0
Australia
Phone 82028 0
+61 03 9371 0213
Fax 82028 0
Email 82028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be shared.
When will data be available (start and end dates)?
Data will be available after publication, with no confirmed end-date.
Available to whom?
Researchers and/or relevant industry services.
Available for what types of analyses?
The data will be available for others to cross-check study results.
How or where can data be obtained?
The data will be stored in the University of South Australia repository.


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.