None listed
Conditions
Brief summary
The study intends to investigate the efficacy of a broad-spectrum micronutrient (vitamins, minerals, amino acids) intervention delivered alongside an online mindfulness programme to help children who struggle to regulate their emotions. The study will be placebo-controlled, meaning that some children will get the active micronutrient formula and others, an inactive placebo formula. Similarly, some children will get access to the mindfulness programme, and others will be actively monitored throughout the trial. By the end of the study, every child will have tried both interventions, including the active formula for those who initially received the placebo. We believe that both interventions, both individually and in conjunction, will help relieve symptoms of emotional dysregulation in children aged 6–10 years old.
Interventions
Participants will be randomly allocated to one of four groups:
1. micronutrient + active monitoring
2. micronutrient + mindfulness
3. placebo + active monitoring
4. placebo + mindfulness
The micronutrient intervention will begin first over an eight-week period, followed by the mindfulness intervention over a six-week period beginning week 3 of the micronutrient intervention. This initial eight-week period is the Randomised Controlled Trial (RCT) phase and will be followed by a second eight-week
Participants will be randomly allocated to one of four groups: 1. micronutrient + active monitoring 2. micronutrient + mindfulness 3. placebo + active monitoring 4. placebo + mindfulness The micronutrient intervention will begin first over an eight-week period, followed by the mindfulness intervention over a six-week period beginning week 3 of the micronutrient intervention. This initial eight-week period is the Randomised Controlled Trial (RCT) phase and will be followed by a second eight-week period where all participants receive micronutrients, and those who did not receive the mindfulness intervention in the RCT will now have access to the online program. Intervention 1: Micronutrient intervention. Participants will be randomly assigned to receive either a micronutrient formula or a placebo for eight weeks. After eight weeks, all participants will enter into an open-label phase whereby all participants can choose to take the micronutrient formula for another eight weeks. Both the micronutrients and placebo are in powdered form and are to be taken orally (dissolved on the tongue) at one powdered sachet per day (2.6g). The micronutrient intervention is a blend of 36 vitamins, minerals, and amino acids. The formula, Truehope Ultimate Sticks, is being manufactured and donated by Truehope Nutritional Support Ltd. and consists of the following ingredients: Vitamin A (as retinyl palmitate) 0.03 mg, Vitamin C (ascorbic acid) 10.00mg, Vitamin D (as cholecalciferol) 0.60 mcg, Vitamin E (as d-alpha tocopheryl succinate) 4.00 mg, Thiamin (as thiamin mononitrate) 0.30 mg, Riboflavin 0.23 mg, Niacin (as niacinamide) 1.50 mg, Vitamin B6 (as pyridoxine hydrochloride) 0.60 mg, Folic acid 0.02mg, Vitamin B12 (as cyanocobalamin) 0.02 mg, Biotin 0.02mg, Pantothenic acid (as calcium pantothenate) 0.35 mg, Calcium (as chelate) 22.00 mg, Iron (as chelate) 0.23 mg, Phosphorus (as chelate) 14.00 mg, lodine (from pacific kelp) 3.40 mcg, Magnesium (as chelate) 10.00 mg, Zinc (as chelate) 0.80 mg, Selenium (as chelate) 3.40 mcg, Copper (as chelate) 0.12 mg, Manganese (as chelate) 0.16 mg, Chromium (as chelate) 0.01 mg, Molybdenum (as chelate) 2.40 mcg, Potassium (as chelate) 4.00 mg, Proprietary blend 27.72mg: [Choline bitartrate, DL-phenylalanine, vanadium chelate, citrus bioflavonoids, Inositol, L-glutamine, L-methionine, boron chelate, grape seed extract, ginkgo leaf extract, germanium sesquioxide, nickel chelate] Other ingredients: erythritol, natural flavors, malic acid. Adherence to the intervention will be assessed fortnightly with any missed dosages reported via Qualtrics. Intervention 2: Mindfulness programme. Participants will be randomly assigned to receive either access to an online weekly mindfulness programme or to active monitoring (treatment as usual) for eight weeks. After eight weeks, all participants in the active monitoring condition will be given access to the mindfulness programme in the open-label phase. The mindfulness programme is an adaptation of an existing programme; Mindkiwi. The original Mindkiwi programme was created for children with ADHD and their families. The adapted programme for this study is abbreviated (6 weeks instead of 8), and has removed all reference to ADHD in order to make it generic to any child with emotion regulation challenges. It consists of weekly videos to watch which involve interactive activities to promote mindfulness such as meditation, muscle relaxation, and mindful breathing. Participants will be supplied both hard-copy materials (e.g. resources required for activities such as balloons, pens, paper etc) and online materials such as weekly worksheets. These materials have been selected specifically from the original Mindkiwi programme for use in this study. Participation requires both the child and a nominated parent/caregiver to engage with the mindfulness videos. There are separate videos for child and parent/caregiver which can be completed at a convenient time throughout the week. Participants will have exclusive access to this programme via their unique login to the Mindkiwi website. Engagement for children per week is approximately twenty minutes. Engagement for parents/caregivers per week is approximately thirty minutes. For participants who are randomly selected to receive this programme, only the micronutrient/placebo formula will be delivered for the first two weeks, after which the mindfulness programme will commence (hence the adapted programme being only 6 weeks instead of 8). This is to allow for the optimisation of brain function before learning takes place. Adherence to the programme will be monitored by website analytics. Participants must complete modules and click to move on, therefore it is possible to see each participant's progress through the course at any given time. As each week has specific tasks, it will be apparent if participants have not completed the tasks required for that week. It is not possible for participants to skip modules.
Sponsors
Professor Julia Rucklidge
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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).
Outcome results
None listed