ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

ME Intervention

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Emotional problems

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Mental Health

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]

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]

Acceptability

Timepoint [1]

Baseline and 3-months post-randomisation

Primary outcome [2]

Feasibility.

Timepoint [2]

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.

Secondary outcome [1]

Physical activity

Timepoint [1]