Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001304820
Ethics application status
Approved
Date submitted
12/07/2021
Date registered
27/09/2021
Date last updated
9/02/2022
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a parenting program intervention (Tuning into teens (TINT)) to investigate parenting behaviour and adolescent brain development
Scientific title
Using a parenting program intervention (Tuning into teens (TINT)) to investigate the causal effect of parenting behaviour on the neurodevelopmental correlates of emotion regulation in adolescents
Secondary ID [1] 304227 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion dysregulation 321925 0
Depression 321926 0
Anxiety 321928 0
Condition category
Condition code
Mental Health 319648 319648 0 0
Depression
Mental Health 319649 319649 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NAME
Tuning Into Teens (TINT)
WHY
TINT is an evidence-based adaptation of the Tuning into Kids (TIK) parenting program for adolescents aged 10-18, based on an emotion socialisation theoretical framework. The goal of the TINT program is to teach parents an adaptive style of responding to children’s emotions, called ‘emotion coaching’.
WHAT
The TINT program uses a variety of methods, including a) lecturing and audio visual material to deliver new content, b) specific exercises that allow practicing a newly learned skill and c) several methods of role play. The topic of the sessions include: 1) Foundations for emotion coaching 2) Connecting and emotional acceptance 3) Building intimacy and showing empathy 4) Emotion coaching worry and sadness 4) Emotion coaching anger 6) Emotion coaching now and in the future. All program materials are readily available resources from the TIK suite, as provided by the author of the program.
WHO PROVIDED
Facilitators will be research fellows and graduate research students with a background in mental health trained in the TINT program. Debriefing and supervision will be provided weekly by the author of the program.
HOW
TINT involves an 8-week x 1 hourly one-on-one sessions. We will record the attendance of each participant. Only adolescents whose mothers complete at least 5 out of 8 TINT sessions will be eligible to complete all follow-up components (including the MRI).
WHERE
The intervention will be offered either online (via Zoom) or in person (Melbourne Neuropsychiatry Centre, The University of Melbourne).
TAILORING
The intervention is structured and will be delivered in the same way to all parents.
Intervention code [1] 320560 0
Behaviour
Intervention code [2] 320561 0
Prevention
Comparator / control treatment
Waitlist control
Participants in the control group will receive the TINT intervention after the follow-up visit at 6-month post intervention.
Control group
Active

Outcomes
Primary outcome [1] 327523 0
Adolescent brain function assessed using functional magnetic resonance imaging during an emotion regulation task.
Timepoint [1] 327523 0
6 month follow-up
Primary outcome [2] 328999 0
Adolescent brain connectivity assessed using functional magnetic resonance imaging during an emotion regulation task.
Timepoint [2] 328999 0
6 month follow-up
Secondary outcome [1] 395510 0
Adolescent HPA-axis function (measured via hair cortisol concentration)
Timepoint [1] 395510 0
6 month follow-up
Secondary outcome [2] 398182 0
Adolescent depressive symptoms assessed using the Revised Children’s Anxiety and Depression Scale (RCADS)
Timepoint [2] 398182 0
6 month follow-up
Secondary outcome [3] 398183 0
Adolescent anxiety symptoms assessed using the RCADS
Timepoint [3] 398183 0
6 month follow-up and 8 month follow-up
Secondary outcome [4] 401123 0
Adolescent emotion regulation assessed using the Emotion Expression Scale for Children
Timepoint [4] 401123 0
6 month follow-up and 8 month follow-up
Secondary outcome [5] 401124 0
Parenting behaviour assessed using the Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS)
Timepoint [5] 401124 0
Post-intervention (8 weeks post-intervention commencement) and 6 month follow-up
Secondary outcome [6] 401125 0
Parent emotion socialisation behaviour assessed by a parent-child interaction/discussion task
Timepoint [6] 401125 0
Post-intervention (8 weeks post-intervention commencement) and 6 month follow-up.
Secondary outcome [7] 401126 0
Parent emotion socialisation behaviour assessed using the Emotions As a Child scale
Timepoint [7] 401126 0
Post-intervention (8 weeks post-intervention commencement) and 6 month follow-up.
Secondary outcome [8] 406119 0
Adolescent emotion regulation assessed using Difficulties in Emotion Regulation Scale (parent-report).
Timepoint [8] 406119 0
6 month follow-up and 8 month follow-up

Eligibility
Key inclusion criteria
- Female adolescents between the ages of 10 and 12 at the time of participation, and their female primary caregivers
- Adolescents have elevated anxiety or depressive symptoms as determined by above the 50th percentile of RCADS scale (self-report)
- Adolescents and parents (of adolescents) able to provide informed consent
- Adequate comprehension of written and spoken English
- Adequate computer knowledge (for online intervention delivery and parent-child interaction recording at home)
- Adolescents and parents (of adolescents) agree to receiving information on MRI incidental findings if relevant
Minimum age
10 Years
Maximum age
12 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria apply to adolescents, which include:
- Current diagnosis of developmental or intellectual disorder
- Current use of psychotropic medication
- Any contraindications to MRI. For example, metal in the body or implants that cannot be removed (e.g., piercings, orthodontic braces, cardiac pacemakers, or other implantable devices).
- Indications of claustrophobia
- History of head trauma or loss of consciousness for 5 minutes or more as a result of head injury
- Obesity (BMI >30)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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
Waitlist control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A comprehensive set of group random-effects analyses adopting appropriate whole-brain criteria for statistical thresholding (familywise-error [FWE] corrected at the cluster level p < 0.05) will be performed to examine within group and between-group effects in relation to the primary task functional parameters of interest. For task-induced changes in BOLD signal activation, a general linear model will be set up for each participant and modelled according to the task-specific regressors. Statistical maps will be generated for each participant and contrasts will be set-up to look at conditions of interest within the task. ANCOVA will be used to examine group (intervention vs control) by time (baseline and 6 month follow-up) effects on whole- brain activation for the task. We will also use generalised psychophysiological interaction (gPPI) analysis to estimate whole brain connectivity with regions of interest (amygdala, ventromedial prefrontal cortex).

Brain function from significant clusters from the above analysis will be extracted and used in subsequent mediation models, which will test whether measures of parent emotion socialisation and other aspects of parenting (from the observed mother-daughter interaction task and questionnaires at post-intervention (follow-up 1) and 6 month follow-up) mediate the association between group (intervention vs control) and brain function at follow-up. Baseline BOLD signal activation and baseline parenting variables will be included as covariates in mediation analyses.

Adolescent baseline internalising symptoms (RCADS depression and anxiety symptom scores) will be tested as moderators in the above analyses to investigate whether adolescents with higher baseline symptoms are more likely to exhibit changes in brain function as a result of the intervention.

Exploratory: ANCOVA will be used to test group by time effects on hair cortisol concentration, and mediation analyses will be used to test whether brain function mediates the association between group and adolescent internalising symptoms and emotion regulation. baseline variables will be includes as covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308606 0
Government body
Name [1] 308606 0
NHMRC
Country [1] 308606 0
Australia
Primary sponsor type
Individual
Name
Prof Sarah Whittle
Address
Melbourne Neuropsychiatry Centre
Department of Psychiatry
The University of Melbourne
Lvl 3, 161 Barry St, Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 309467 0
Individual
Name [1] 309467 0
Dr Elena Pozzi
Address [1] 309467 0
Melbourne Neuropsychiatry Centre
Department of Psychiatry
The University of Melbourne
Lvl 3, 161 Barry St, Carlton, VIC 3053
Country [1] 309467 0
Australia
Secondary sponsor category [2] 309468 0
Individual
Name [2] 309468 0
Prof Sophie Havighurst
Address [2] 309468 0
Department of Psychiatry
The University of Melbourne
161 Barry St, Carlton, VIC 3053
Country [2] 309468 0
Australia
Secondary sponsor category [3] 309469 0
Individual
Name [3] 309469 0
Dr Christiane Kehoe
Address [3] 309469 0
Department of Psychiatry
The University of Melbourne
161 Barry St, Carlton, VIC 3053
Country [3] 309469 0
Australia
Secondary sponsor category [4] 309470 0
Individual
Name [4] 309470 0
Dr Orli Schwartz
Address [4] 309470 0
Orygen Youth Health
35 Poplar Rd, Parkville VIC 3052
Country [4] 309470 0
Australia
Secondary sponsor category [5] 309471 0
Individual
Name [5] 309471 0
A/Prof Marie Yap
Address [5] 309471 0
Department of Psychology
Monash University
Wellington Rd, Clayton VIC 3800
Country [5] 309471 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308537 0
Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 308537 0
Ethics committee country [1] 308537 0
Australia
Date submitted for ethics approval [1] 308537 0
30/07/2021
Approval date [1] 308537 0
08/10/2021
Ethics approval number [1] 308537 0

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

Contacts
Principal investigator
Name 111058 0
Prof Sarah Whittle
Address 111058 0
Melbourne Neuropsychiatry Centre
Department of Psychiatry
The University of Melbourne
Lvl 3, 161 Barry St, Carlton, VIC 3053
Country 111058 0
Australia
Phone 111058 0
+61 03 8344 1958
Fax 111058 0
Email 111058 0
[email protected]
Contact person for public queries
Name 111059 0
Sarah Whittle
Address 111059 0
Melbourne Neuropsychiatry Centre
Department of Psychiatry
The University of Melbourne
Lvl 3, 161 Barry St, Carlton, VIC 3053
Country 111059 0
Australia
Phone 111059 0
+61 03 8344 1958
Fax 111059 0
Email 111059 0
[email protected]
Contact person for scientific queries
Name 111060 0
Sarah Whittle
Address 111060 0
Melbourne Neuropsychiatry Centre
Department of Psychiatry
The University of Melbourne
Lvl 3, 161 Barry St, Carlton, VIC 3053
Country 111060 0
Australia
Phone 111060 0
+61 03 8344 1958
Fax 111060 0
Email 111060 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 demographic, behavioural and clinical measures, de-faced and de-identified MRI scans
When will data be available (start and end dates)?
Immediately following publication, 15 years after last publication
Available to whom?
Ethically approved research projects, databanks or biobanks, or medical journals
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
Email: [email protected]


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.