Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000456257
Ethics application status
Approved
Date submitted
4/02/2018
Date registered
29/03/2018
Date last updated
15/09/2021
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning in to Teens for Residential Care Workers: A Pilot Study
Scientific title
A Pilot Study of the 'Tuning into Teens for Residential Care Workers (TINT RCW)' Program: Assessing the effect on worker's responsiveness, mental health and the residential care climate
Secondary ID [1] 293490 0
NIl
Universal Trial Number (UTN)
Trial acronym
TINT: RCW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of young person internalising and externalising behavioural problems 305710 0
Promotion of parenting skills 305711 0
behaviour problems 306536 0
Condition category
Condition code
Mental Health 304927 304927 0 0
Other mental health disorders
Public Health 304928 304928 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TINT RCW is a six session fortnightly group program running for 2 hours for residential care workers to assist their residents to understand and manage their emotions. The program also provides residential care workers with skills in understanding and managing their own emotions thereby reducing the stress of caring for residents and improving the workers mental health. The program is delivered using psychoeducation, role play practice, group discussions, exercises and home exercises. The program is delivered by facilitators experienced in TINT training and uses a structured manual published by the University of Melbourne (Tuning in to Teens: Program Manual) with fidelity checklists used to ensure maximum adherence to the program.

Session one introduces workers to the concepts of emotional intelligence and emotion coaching. Session two builds awareness of emotions; session three targets empathy; session four focuses on emotional self care for the worker and responding to anxiety; session five focused on developing workers awareness of their own response to anger, both in themselves and the residents; session six provides final opportunities to practise the skills and cover any last materials not addressed in the earlier sessions. Workers are asked to try out the skills between sessions with their residents (home activities) however, these are optional and not specifically monitored. The program runs for a total of 6 sessions stretched as fortnightly sessions over a 12 week period. The program is delivered according to the published manual.
Intervention code [1] 299756 0
Prevention
Intervention code [2] 300287 0
Behaviour
Comparator / control treatment
Control houses will receive the intervention six months after intervention houses.
Control group
Active

Outcomes
Primary outcome [1] 304586 0
Change in emotion socialisation of the residential care worker to resident's emotions using the 'Emotions as a Child' Scales and 'Difficulties in Emotion Regulation Scale'.
These are a composite primary measure called emotion socialisation.
Timepoint [1] 304586 0
Immediately pre-intervention and three months following intervention completion.
Primary outcome [2] 304587 0
Changes in mental health of residents (measured using the Strengths and Difficulties Questionnaire)
Timepoint [2] 304587 0
Immediately pre-intervention and three months following intervention completion.
Primary outcome [3] 304588 0
Changes in the residential house emotional climate (using data about critical incidents occurring in the house).
This will be assessed using data recorded about the number of critical incidents logged in the house. Critical incidents include physical or emotional incidents to the resident or the worker and are lodged by the house as part of the Department of Health and Human Services protocol.
Timepoint [3] 304588 0
Immediately pre-intervention and three months following intervention completion.
Secondary outcome [1] 342467 0
Changes in residential worker stress (using the Depression, Anxiety and Stress Scale)
Timepoint [1] 342467 0
Immediately pre-intervention and three months following intervention completion.
Secondary outcome [2] 343726 0
Changes in the residential house emotional climate (using data about worker absences).
This will be assessed using residential house records from house data along with residential carer interviews.
This is an additional primary outcome about house emotion climate.
Timepoint [2] 343726 0
Immediately pre-intervention and at 3-months post-intervention.
Secondary outcome [3] 344729 0
Residential worker absences from work
Timepoint [3] 344729 0
At three month follow up.

Eligibility
Key inclusion criteria
Residential care worker must be employed and working in a residential care home.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the residential worker has insufficient English to complete measures.

Study design
Purpose of the study
Educational / counselling / training
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
The study will use a randomised controlled design with up to 100 residential care workers who work with children and young people with behaviour problems (oppositional, aggressive or challenging behaviours) within 12 residential homes. Up to 4 children and/or young people reside in each home. These young people will have been placed in residential care facilities due to not being able to live with family or in foster/kinship care. Up to ten staff are employed on a rostered basis within each home.

Each residential home will be randomised into one of two conditions (intervention or waitlist control). Baseline, post-intervention and six-month follow-up data will be collected from residential care workers via questionnaires. Residential houses and residential workers will be recruited through the Residential Care Learning Development Strategy group within the Centre of Excellence (Child and Family peak body). Community Service Organisations who operate out of home care services will receive Plain Language Statements, residential care managers and staff will receive Plain Language Statements and participating staff will receive a consent form and a questionnaire booklet. A questionnaire booklet will also be filled in by residential care workers after the intervention. The intervention will consist of six two hour fortnightly sessions facilitated by trainers experienced in delivering the Tuning in to Teens intervention. A structured Tuning in to Teens manual will be used to deliver the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample is anticipated to be about 96 residential workers who will be allocated to either intervention or waitlist (approximately 48 in each condition). Previous studies of TINT have shown that medium to large effect sizes are found on parenting measures but it is not clear whether the same will be found for residential workers. Because this is a pilot study, power may not be achieved but the study aims to determine whether changes occur in the predicted direction and whether the intervention is feasible.

Once data are collected, descriptive statistics about the houses, residential care workers and young people will be conducted. Comparisons of data between intervention and control houses/participants using ANOVA in SPSS will also be carried out. This will enable testing of whether the intervention leads to differences between intervention and control participants across the different areas of measurement.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
2/09/2019
Date of last participant enrolment
Anticipated
1/01/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
130
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18694 0
3032 - Travancore
Recruitment postcode(s) [2] 18695 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 298108 0
Other
Name [1] 298108 0
University
Country [1] 298108 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Mindful, Centre for Training and Research in Developmental Health,
Department Psychiatry,
The University of Melbourne;
Building C,
50 Flemington St,
Travancore, 3032, VIC.
Country
Australia
Secondary sponsor category [1] 297186 0
Charities/Societies/Foundations
Name [1] 297186 0
Orygen Youth Mental Health
Address [1] 297186 0
Orygen, 35 Poplar Road Parkville Vic 3052, VIC
Country [1] 297186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299127 0
University of Melbourne
Ethics committee address [1] 299127 0
Ethics committee country [1] 299127 0
Australia
Date submitted for ethics approval [1] 299127 0
26/03/2018
Approval date [1] 299127 0
13/11/2018
Ethics approval number [1] 299127 0
1851571

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

Contacts
Principal investigator
Name 79390 0
A/Prof Sophie Havighurst
Address 79390 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 79390 0
Australia
Phone 79390 0
+61 3 93710200
Fax 79390 0
Email 79390 0
[email protected]
Contact person for public queries
Name 79391 0
Sophie Havighurst
Address 79391 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 79391 0
Australia
Phone 79391 0
+61 3 93710200
Fax 79391 0
Email 79391 0
[email protected]
Contact person for scientific queries
Name 79392 0
Sophie Havighurst
Address 79392 0
Mindful
University of Melbourne
Building C
50 Flemington Street
Travancore 3032
VIC
Country 79392 0
Australia
Phone 79392 0
+61 3 93710200
Fax 79392 0
Email 79392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not part of ethical approval and this is personal data.


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.