Efficacy of broad-spectrum micronutrients delivered via oral mucosa alongside an online mindfulness programme as an intervention for emotional dysregulation in children aged 6–10 years: a randomised controlled trial

Professor Julia Rucklidge0 sites160 target enrollmentMay 27, 2024

Overview

No summary available.

Registry

who.int

Start Date

May 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Professor Julia Rucklidge

•1\)Participants must meet criteria for emotional dysregulation as indicated by scores of 10 or more on the Emotion Dysregulation Inventory\-Reactivity subscale (parent report) and an average score of 1 or more on the Parent\-rated Affective Reactivity Index (ARI) and be assessed as moderate impairment by the Clinical Global Impression Severity (CGI\-S),
•2\)Must be aged between 6 and 10 years of age,
•3\)Participants must have English competency sufficient to correctly interpret and complete study materials and questionnaires,
•4\)Must be medication free (psychiatric) for \>4 weeks,
•5\)Be able to ingest 1 powder sachet per day,
•6\)Have at least one parent/caregiver/whanau member able to attend 6 weekly therapy sessions online with the child and access to the internet. To ensure the data collected are valid, it is important that the same parent/caregiver is available for reviews and sessions. This will be made clear in the consent meeting.

•1\)Any serious medical or psychiatric condition potentially requiring hospitalisation,
•2\)Known allergy to any of the Stick or Placebo ingredients, or known abnormality of mineral metabolism (e.g., Wilson’s disease, hemochromatosis),
•3\)Epilepsy and,
•4\)Any serious mental health or behavioural concerns for either parents or child that may interrupt their ability to engage with the online programme or compromise therapeutic learning (e.g., severe conduct disorder, low intellectual functioning, traumatic brain injury, pervasive developmental disorder, severe parental substance abuse or psychiatric disorder).