Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000511538
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
My Emotions Community Trial: A waitlist randomized controlled trial of a brief clinic-based parent-child emotions intervention program for children aged 5-13 years
Scientific title
My Emotions Community Trial: A waitlist randomized controlled trial to assess the feasibility and acceptability of a brief clinic-based parent-child emotions intervention program for children aged 5-13 years
Secondary ID [1] 311888 0
nil
Universal Trial Number (UTN)
Trial acronym
ME Community
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emotional problems 333467 0
Condition category
Condition code
Mental Health 330139 330139 0 0
Anxiety
Mental Health 330140 330140 0 0
Depression
Mental Health 330141 330141 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The My Emotions intervention involves three 50-minute face-to-face sessions at 2 week intervals delivered by a clinician (e.g., Paediatrician or Psychologist or Provisional Psychologist). The first session will focus on assessing specific emotions problems that the child is experiencing and setting goals in relation to these problems. Families will be provided with psychoeducation, which involves information about the role of emotions, core emotions, modulation of emotions, how emotions mix together, and communication about emotions.
Normal emotions refer to the typical range of feelings and reactions that people commonly experience in response to various situations and stimuli. These emotions can include happiness, sadness, anger, fear, disgust, and more. They are considered normal because they are part of the human experience and serve important functions in our lives, such as helping us navigate relationships, make decisions, and respond to threats or opportunities. Normal emotions may vary in intensity and duration depending on individual differences, cultural norms, and the specific context of a situation. Overall, they contribute to our psychological well-being and are essential for our emotional health.
Emotional regulation refers to the ability to effectively manage and modulate one's own emotions in response to internal and external stimuli. It involves being aware of your emotions, understanding what triggers them, and employing strategies to regulate their intensity and duration. Emotional regulation is crucial for maintaining emotional stability, navigating social interactions, and making sound decisions.
Families are also provided with a tailored plan during the first session that is specific to the emotions diagnosis of the child, and which includes their agreed upon goals and tailored emotions management techniques.
Examples of the emotions management techniques that may be individually tailored to participants include Emotional Problem Solving to treat emotional responses to triggering events, Managing Anxiety or Separation Anxiety, Managing Anger, and Coping and Calming to build emotional regulation skills. Families will be given an optional emotions diary and asked to record emotions for the two weeks following the first face-to-face session, on a daily basis.
Clinicians will keep a study consultation form of the session to document precipitating, predisposing, and perpetuating factors impacting the child’s emotions problems, which includes home environment, medications and co-morbid psychological disorders.
The second session is held two weeks later and will be used to reinforce strategies, monitor emotions (by reviewing an emotions diary), and to troubleshoot any difficulties that the family may be experiencing. This will involve discussing the use of the strategies recommended in the first session. This will involving reviewing the optional emotions diary (if completed over the preceding period) and discussing the use of the strategies recommended in the first session. These details, alongside any new strategies recommended and other relevant clinical information will be recorded.
The final session (two weeks later) offers an additional opportunity to provide support and trouble shoot any issues.
The clinicians will attend an initial 2 hour training session on the intervention prior to commencing sessions and participate in fortnightly group supervision sessions. The supervision will involve case reflection, training and simulation of intervention components, clinical governance of case work.
Intervention code [1] 328353 0
Other interventions
Comparator / control treatment
Upon receipt of consent and completion of the baseline surveys, families will be randomised by a researcher independent of the project, to either the My Emotions intervention or the wait list (control) group. The control group will be invited to receive the intervention following 3-month follow-up surveys.
Control group
Active

Outcomes
Primary outcome [1] 337889 0
Feasibility
Timepoint [1] 337889 0
Baseline and 3-months post-randomisation
Primary outcome [2] 337890 0
Acceptability
Timepoint [2] 337890 0
Baseline and 3-months post randomisation
Secondary outcome [1] 433605 0
Children's level of emotional functioning
Timepoint [1] 433605 0
3 months post randomisation

Eligibility
Key inclusion criteria
Child aged 5-13 years
Child with moderate—severe parent/caregiver-reported emotional problems
Child and parent/caregiver living in Victoria
Parent/caregiver sufficient English proficiency to provide informed consent and answer online questionnaires.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have acute mental health risks as identified in the screening questionnaire. Under the direction of a senior supervisor or clinic manager, they will be excluded from the research study and referred to the Child and Youth Mental Health Service in their area and/or to their paediatrician for treatment.

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)
Allocation concealed using the randomisation module in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician independent to this study will randomise participants using a computer generated randomisation sequence with 1:1 ratio between groups and blocks of four, six, and eight in size stratified by gender.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics and qualitative data analysis (template analysis) of open-ended responses will be used to describe primary outcomes.
For secondary outcomes, analyses will be conducted on an intention-to-treat basis. The mean difference in primary and secondary outcomes between the intervention and wait list control groups at the 3- and 6-month post-randomisation time points will be carried out using linear mixed effects regression with results presented as mean differences (and 95% CIs). Analyses will also be run adjusting for baseline functioning and potentially confounding a priori variables. Given the proof-of-principle nature of this study, it will focus on effect sizes (Cohen’s d) rather than statistical significance testing. If the sample size recruited is not sufficiently powered to conduct this analysis, a mixed ANOVA will be conducted and not adjusted for covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316236 0
University
Name [1] 316236 0
Monash Krongold Clinic
Country [1] 316236 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318423 0
None
Name [1] 318423 0
Address [1] 318423 0
Country [1] 318423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315059 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315059 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 315059 0
Australia
Date submitted for ethics approval [1] 315059 0
13/11/2023
Approval date [1] 315059 0
04/01/2024
Ethics approval number [1] 315059 0
40987

Summary
Brief summary
We aim to determine whether the My Emotions intervention, delivered by provisional psychologists in their usual work setting, is feasible, acceptable, and effective. Therefore, in this waitlist controlled randomised controlled trial, we aim to determine whether a brief emotions intervention delivered by provisionally registered psychologists:
1. Is feasible and acceptable when delivered in real life clinical settings (primary outcome)
2. Decreases emotions problems as measured by the Strengths and Difficulty Questionnaire (SDQ) at 3-months post randomisation follow-up (secondary outcome).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133538 0
Dr David Moseley
Address 133538 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800, Victoria
Country 133538 0
Australia
Phone 133538 0
+61 3 9905 4393
Fax 133538 0
Email 133538 0
david.moseley@monash.edu
Contact person for public queries
Name 133539 0
David Moseley
Address 133539 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800, Victoria
Country 133539 0
Australia
Phone 133539 0
+61 3 9905 4393
Fax 133539 0
Email 133539 0
david.moseley@monash.edu
Contact person for scientific queries
Name 133540 0
David Moseley
Address 133540 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800, Victoria
Country 133540 0
Australia
Phone 133540 0
+61 3 9905 4393
Fax 133540 0
Email 133540 0
david.moseley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Some data may be identifiable and health related


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22103Ethical approval    387620-(Uploaded-04-04-2024-14-37-34)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
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