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Trial registered on ANZCTR


Registration number
ACTRN12625000046404p
Ethics application status
Submitted, not yet approved
Date submitted
9/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing My Emotions: A brief parent-child psychological intervention for children with emotional difficulties aged 5-13 years
Scientific title
Assessing the acceptability and feasibility of My Emotions: A brief parent-child, psychological intervention for children with emotional difficulties aged 5-13 years
Secondary ID [1] 313533 0
nil
Universal Trial Number (UTN)
Trial acronym
ME Intervention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional problems 336004 0
Condition category
Condition code
Mental Health 332580 332580 0 0
Anxiety
Mental Health 332581 332581 0 0
Depression
Mental Health 332582 332582 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The My Emotions intervention involves three to six 50-minute face-to-face sessions at one-week intervals delivered by a clinician (e.g., Paediatrician or Psychologist or Provisional Psychologist). The sessions will be attended by the child and at least one parent. Other support people, such as grandparents or support workers, may also attend sessions if the family wishes, to help them support the intervention at home. The first session will focus on assessing specific emotional 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 emotional diagnosis of the child and includes their agreed-upon goals and tailored emotion 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 following the first face-to-face session daily.
Clinicians will keep a study consultation form of the session to document precipitating, predisposing, and perpetuating factors impacting the child’s emotional problems, which include home environment, medications and co-morbid psychological disorders.
The second session is held one week later and will be used to reinforce strategies, monitor emotions (by reviewing an emotions diary), and 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 involve 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 (one week later) offers an additional opportunity to provide support and troubleshoot any issues. following the conclusion of session three, families can opt-in for up to three additional sessions, depending on progress and need.
Session adherence will be monitored by booking sessions ahead of time, offering substitute appointments in case of cancellations, and recording attendance in the clinical notes, which will be reviewed as part of the research process.
Clinicians will attend a comprehensive training session one month prior to the intervention start date (approx. 2 hours). Clinicians will attend weekly individual supervision sessions (approx. 60 minutes) and fortnightly group supervision sessions (approx. 30-60 minutes). The supervision will involve case reflection, training and simulation of intervention components, and clinical governance of casework. Clinicians will work with multiple families over their year-long placement at the clinic, working with each family for approximately 3-months.
Intervention code [1] 330124 0
Behaviour
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] 340094 0
Feasibility.
Timepoint [1] 340094 0
Study-level outcomes will be assessed upon the conclusion of the study. Participant-level outcomes will be assessed at baseline and 3 months post-randomisation.
Primary outcome [2] 340095 0
Acceptability
Timepoint [2] 340095 0
Baseline and 3-months post-randomisation
Secondary outcome [1] 442637 0
Mental health
Timepoint [1] 442637 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.
Secondary outcome [2] 442696 0
Wellbeing
Timepoint [2] 442696 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.
Secondary outcome [3] 442697 0
Wellbeing
Timepoint [3] 442697 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.
Secondary outcome [4] 442699 0
Sleep
Timepoint [4] 442699 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.
Secondary outcome [5] 442701 0
Physical activity
Timepoint [5] 442701 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.
Secondary outcome [6] 442702 0
Self-efficacy
Timepoint [6] 442702 0
Baseline, 3 months post-randomisation, and 6 months post-randomisation.

Eligibility
Key inclusion criteria
Child aged 5-13 years
Child with 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. 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 waitlist 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, either a mixed ANOVA not adjusted for covariates or a single case design will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2025
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] 317995 0
Charities/Societies/Foundations
Name [1] 317995 0
MECCA M-POWER
Country [1] 317995 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320334 0
None
Name [1] 320334 0
Address [1] 320334 0
Country [1] 320334 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316658 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 316658 0
Ethics committee country [1] 316658 0
Australia
Date submitted for ethics approval [1] 316658 0
25/11/2024
Approval date [1] 316658 0
Ethics approval number [1] 316658 0

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

Contacts
Principal investigator
Name 138562 0
Dr David Moseley
Address 138562 0
Monash University, Faculty of Medicine, Nursing and Health Sciences, School of Psychological Sciences, 18 Innovation Walk, Monash University, Victoria, 3800 , Australia
Country 138562 0
Australia
Phone 138562 0
+61 3 9905 4393
Fax 138562 0
Email 138562 0
david.moseley@monash.edu
Contact person for public queries
Name 138563 0
David Moseley
Address 138563 0
Monash University, Faculty of Medicine, Nursing and Health Sciences, School of Psychological Sciences, 18 Innovation Walk, Monash University, Victoria, 3800 , Australia
Country 138563 0
Australia
Phone 138563 0
+61 3 9905 4393
Fax 138563 0
Email 138563 0
david.moseley@monash.edu
Contact person for scientific queries
Name 138564 0
David Moseley
Address 138564 0
Monash University, Faculty of Medicine, Nursing and Health Sciences, School of Psychological Sciences, 18 Innovation Walk, Monash University, Victoria, 3800 , Australia
Country 138564 0
Australia
Phone 138564 0
+61 3 9905 4393
Fax 138564 0
Email 138564 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?

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.