Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000483752
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
28/03/2022
Date last updated
7/03/2023
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning in to Teens in Aotearoa New Zealand: evaluating an emotion coaching programme for parents of young adolescents in Child Adolescent Mental Health Services (CAMHS).
Scientific title
Evaluating an emotion coaching programme for parents of young adolescents with anxiety and depression in Child Adolescent Mental Health Services (CAMHS) in New Zealand: a multi-site feasibility trial including co-design with service users.
Secondary ID [1] 306607 0
None
Universal Trial Number (UTN)
U1111-1275-0801
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in young adolescents 325518 0
Depression in young adolescents 325519 0
Condition category
Condition code
Mental Health 322891 322891 0 0
Anxiety
Mental Health 322892 322892 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tuning in to Teens TM (TINT). This is a programme for parents of adolescents that has been adapted from a programme for younger children, Tuning into Kids TM by Professor Sophie Havighurst and team at the University of Melbourne. This programme aims to support parents to better ‘tune in’ to the emotions of their children by becoming ‘emotion coaches’. Emotion coaching is an adaptive emotion socialisation style which encourages understanding and acceptance of emotional experience

TINT is designed to be delivered in a group format over either 6 or 8 weekly sessions of two hours each. An 8-week format will be used for the study as the recommended format for clinical settings. Sessions will be held at Child Adolescent Mental Health Services (CAMHS) and delivered by trained CAMHS clinicians. The focus of sessions is teaching emotion coaching skills. Sessions also include information about adolescent development, teaching of emotion regulation skills such as mindfulness, and supporting parents to reflect on meta-emotions (i.e. their own beliefs about emotions based on their life experiences). Each session includes a mix of teaching, shared reflection and practicing learnt skills. Participants are encouraged to practice emotion coaching skills outside sessions and there are optional homework tasks assigned each session designed to facilitated parent-teen communication. These are typically worksheet based conversation prompts to complete with their teen focused on different emotions such as ‘How can you tell if a friend is happy or sad?’ Optional homework tasks are expected to take 30-60 minutes per week.

Facilitators may be clinicians in CAMHS of any discipline or experience. They must be trained in delivery of TINT to facilitate the program. Training will be provided by the programme developers. A manual is provided to facilitators to guide sessions. Handouts are provided to parents for each session to review material. A fidelity checklist for each session is provided with the manual which facilitators will complete to check adherence to content. Facilities will have supervision with the research team at set intervals through the study.

Adaptions for the cultural context in New Zealand may be made to running of groups. Unless specifically justified, this will not include significant adaptations to the programme content may include processes around it, for example opening and closing of sessions.

Participants in the intervention arm will also receive other care as usual from CAMHS in the study period, i.e. this is evaluating an addition to usual care not an alternative.

Prior to the start of this trial, a separate sample of participants will recruited from the same population to co-design an outcome measure to be included in the trial. This will involve a group of parents and a group of 10-14 year olds who will each participate in a workshop facilitated by the researchers to discuss how to measure the impact of TINT with the aim of producing a measure to be included in the trial. Workshops will be 2 to 3 hours long with breaks. Facilitation will take the form of open ended questions e.g. "How would you know if something had helped your family?", followed by discussion and structured activities to define outcomes e.g. ranking exercises to pick top outcomes. From these, a draft measure will be developed and follow-up sought as appropriate from participants e.g. to test the measure. Experts in co-design in health in New Zealand are advising on the design and delivery of these workshops.
Intervention code [1] 323037 0
Treatment: Other
Comparator / control treatment
Care as usual – participants will all be under CAMHS and receive care as usual from their treating team.

CAMHS are multidisciplinary teams that may include mental health nurses, social workers, family therapists, psychiatrists and psychologists who typically have additional training and expertise in working with young people and families. A case manager is generally assigned to each case who will coordinate care and may also be a treating clinician. Care plans are discussed and reviewed within the team. For those with primary difficulties related to anxiety or depression, usual care may include any or a combination of: case management, antidepressant medication, individual talking therapy such as CBT, other therapies including group or family based, liaison with school and other agencies. Participants will be asked to complete a checklist indicated components of care received during the study period.
Control group
Active

Outcomes
Primary outcome [1] 330670 0
Parent responses to emotion as measured by the Emotions as a Child Scale (EAC; Magai, 1996) with a score calculated for level of emotion dismissing, higher scores equating to higher levels of emotion dismissing.
Timepoint [1] 330670 0
Baseline (T0), after completing TINT group/matched for controls (T1; primary timepoint), and 8 weeks after completing TINT group/matched for controls (T2).
Primary outcome [2] 330671 0
Emotion regulation as measured by the Difficulties in Emotion Regulate Scale, Short Form (DERS; Gratz & Roemer, 2004) with higher scores equating to greater difficulties with emotion regulation.
Timepoint [2] 330671 0
Baseline (T0), after completing TINT group/matched for controls (T1; primary timepoint), and 8 weeks after completing TINT group/matched for controls (T2).
Secondary outcome [1] 407145 0
Symptoms of depression and anxiety as measured by the Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al. 2000), higher scores equating to higher levels of depression/anxiety and a meaningful improved defined as at least 50% reduction in the raw score or 25% for youth with treatment resistant depression.
Timepoint [1] 407145 0
Time point - Baseline (T0), after completing TINT group/matched for controls (T1), and 8 weeks after completing TINT group/matched for controls (T2).

Eligibility
Key inclusion criteria
For adolescents that they are:
• aged between 10 to 14 years at the time of recruitment.
• accepted into a CAMHS in the Wellington region with a primary presenting difficulty related to a common mental health disorder: i.e. anxiety disorder (including panic, generalised anxiety, social anxiety, separation anxiety) or mood disorder (including depressive disorder or depressive episode).
• competent to complete outcome measures with fluency in English.
• have least one parent/caregiver/whanau member who meets study inclusion criteria.

For parent/caregiver/whanau members that they are:
• aged over 18 years.
• have care of a child in CAMHS who meets the inclusion criteria.
• competent and available to complete the intervention group and outcome measures with sufficient fluency in English
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young person has a primary presenting difficulty that is not related to anxiety or depression e.g. eating disorder, severe developmental disorder (e.g. intellectual disability or autism spectrum disorder).

Young person / parent has communication difficulty (e.g. lacking fluency in English, or, having a learning difficulty which impacts ability to give consent or complete outcome measures).

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)
Central randomisation using software will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Due to the nature of the intervention, participants and clinicians will not be blind to intervention status; however, the researcher collecting outcome data will be blinded to allocation when recording outcomes to reduce risk of bias.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is no set target of participants as this is a feasibility trial and numbers recruited is one of the feasibility objectives.

Analysis for the feasibility trial will be largely descriptive. Variables related to recruitment and retention, acceptability and feasibility of the intervention and, acceptability and feasibility of the outcome measures will be described.

The statistical analyses for preliminary effect sizes from outcome measures will depend on the final outcome measures chosen. Analyses of trial outcomes will be based on intention to treat principles. Analysis will include interim measurements to allow inclusion of participants with partial follow-up.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
9/05/2022
Date of last participant enrolment
Anticipated
1/12/2022
Actual
21/02/2023
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
50
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 24640 0
New Zealand
State/province [1] 24640 0
Wellington

Funding & Sponsors
Funding source category [1] 310943 0
Government body
Name [1] 310943 0
Health Research Council of New Zealand
Country [1] 310943 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 7343
Newtown
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 312236 0
None
Name [1] 312236 0
Address [1] 312236 0
Country [1] 312236 0
Other collaborator category [1] 282184 0
Hospital
Name [1] 282184 0
Capital and Coast District Health Board
Address [1] 282184 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country [1] 282184 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310495 0
Southern Health and Disability Ethics Committees New Zealand
Ethics committee address [1] 310495 0
Ethics committee country [1] 310495 0
New Zealand
Date submitted for ethics approval [1] 310495 0
09/12/2021
Approval date [1] 310495 0
22/12/2021
Ethics approval number [1] 310495 0
2021 FULL 11846

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

Contacts
Principal investigator
Name 117874 0
Ms Zara Mansoor
Address 117874 0
Department of Psychological Medicine, University of Otago
PO BOx 7343, Wellington 6242
New Zealand
Country 117874 0
New Zealand
Phone 117874 0
+6448061894
Fax 117874 0
Email 117874 0
[email protected]
Contact person for public queries
Name 117875 0
Zara Mansoor
Address 117875 0
Department of Psychological Medicine, University of Otago
PO BOx 7343, Wellington 6242
New Zealand
Country 117875 0
New Zealand
Phone 117875 0
+6448061894
Fax 117875 0
Email 117875 0
[email protected]
Contact person for scientific queries
Name 117876 0
Zara Mansoor
Address 117876 0
Department of Psychological Medicine, University of Otago
PO BOx 7343, Wellington 6242
New Zealand
Country 117876 0
New Zealand
Phone 117876 0
+6448061894
Fax 117876 0
Email 117876 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 collected in the study will be submitted to an online data repository (Dryad). The purpose of this submission is to provide a data set that will be available to other researchers for reproduction of analysis results.
When will data be available (start and end dates)?
Start date: following study completion, estimated mid 2023.
End date: no end date.
Available to whom?
Open access.
Available for what types of analyses?
The repository does have any specific restrictions on research activity for uploaded data.
How or where can data be obtained?
The intended Storage location is Dryad (https://datadryad.org)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15310Study protocol  [email protected]
15313Ethical approvalN/A [email protected] 383704-(Uploaded-07-03-2022-08-46-10)-Study-related document.pdf
15314Informed consent formN/A [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating an emotion coaching programme for parents of young adolescents attending Child Adolescent Mental Health Services (CAMHS) in New Zealand: protocol for a multi-site feasibility trial including co-design with service users.2023https://dx.doi.org/10.1186/s40814-023-01282-6
N.B. These documents automatically identified may not have been verified by the study sponsor.