Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000162718
Ethics application status
Approved
Date submitted
12/01/2022
Date registered
31/01/2022
Date last updated
31/01/2022
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Micronutrients and emotion dysregulation in children: single case research design
Scientific title
Micronutrients and emotion dysregulation in children 5-10 years of age: a two-arm withdrawal single-case design
Secondary ID [1] 306131 0
Nil known.
Universal Trial Number (UTN)
U1111-1271-2241.
Trial acronym
EmotioN dYSregUlatioN childreN multiNutrients (SUNNY Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion dysregulation/irritability 324816 0
Sleep 324818 0
Mood 324823 0
Attention Deficit/Hyperactivity Disorder (ADHD) symptoms 324848 0
Oppositional Defiant Disorder (ODD) symptoms 324849 0
Social behaviours 324850 0
Condition category
Condition code
Mental Health 322263 322263 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Micronutrients are vitamins and minerals that have widely been studied across the globe in the context of mental health, and scientific evidence suggests that they have beneficial effects on various psychological concerns, including stress, anxiety, mood, inattention, hyperactivity/impulsivity, emotion dysregulation, and irritability. Because children often display problems with swallowing pills or taking multinutrient powder (due to the unpleasant taste and smell) as well as can often struggle with emotion dysregulation, a new modality of taking micronutrients might represent a new, more convenient way for children to take micronutrients. For those reasons, the proposed study aims to investigate whether the Lightning Stiks are an effective treatment for children between 5 and 10 years of age who struggle with emotion dysregulation and irritability.

The product being tested is called EMP Lightning Stiks which come as powdered straws that use Direct-to-Mouth technology, meaning that all participants have to do is put the powder directly in their mouth and let it dissolve. The Lightning Stiks consist of a blend of 36 ingredients, including vitamins, minerals and amino acids. The advantage of this mode of delivery is that the doses of the ingredients are much lower than those found in capsules and well below the RDA - as such, no ingredient is given in a medicinal dose. Further, all doses are well below the Tolerable Upper Intake Limit (UL), which is considered the highest amount of daily nutrient intake that is not likely to cause any adverse effects. In addition, as the Lightning Stiks are available in various flavours, such as Tropical Punch, Banana, and Sour Berry, they do not have the usual unpleasant smell or taste that micronutrients given in a capsule form can have, and no swallowing capsules is necessary, all reasons why they might be a more convenient alternative option for children. Participants are asked to take one Lightning Stik a day; however, as anecdotal reports have previously reported headaches in the first few days of taking the Lightning Stiks, participants are advised to start with only ½ a straw in this study for the first two days.

The proposed study will investigate the short and long-term effects of the Lightning Stiks using a two-arm withdrawal design, where n=40 participants will be randomised to two groups (20:20) to start the nutrients right away or have the start delayed by one month. Group 1 will take the intervention for four weeks before it will be withdrawn for four weeks, and then reinstated for another 12 weeks. Group 2 will have a delayed 4-week start, then take the intervention for four weeks before it will be withdrawn for four weeks and finally reinstated for another 12 weeks. Randomisation will be determined in blocks of four. The participants are eligible for the study when they display moderate to severe symptoms of emotion dysregulation/irritability, which will be assessed using a questionnaire during the screening phase of the study. There will be 5 study phases in total, and participation for each participant will last about 6-7 months. Every two weeks, parents will answer various psychometric questionnaires assessing their children’s behaviour, including hyperactivity/impulsivity, inattention, emotion dysregulation, irritability, sleep, side effects, and diet. In addition, once a month, the researcher will meet in person with both the parent and the child to collect data on emotional and behavioural dysregulation and irritability, mood, sleep, and social behaviour. To see if the potential changes in the children’s behaviour impacts the parent’s wellbeing and vice versa, parents will fill out a measure assessing symptoms of depression, anxiety, and stress every four weeks. At the end of each month when taking the intervention, the participants will be asked how much product they have left (via an online questionnaire). Since every participants receives 30 pouches of product for the month, this information will be used to calculate adherence.

Ingredient list (active intervention):
Servings per Container: 30
Serving Size: 1 Stik (2.6 g)
Amount per Serving:
Vitamin A (retinyl palmitate) 0.03 mg
Vitamin C (ascorbic acid) 10.00 mg
Vitamin D (cholecalciferol) 0.60 mcg
Vitamin E (d-alpha tocopheryl succinate) 4.00 mg
Thiamin (thiamin mononitrate) 0.30 mg
Riboflavin 0.23 mg
Niacin (niacinamide) 1.50 mg
Vitamin B6 (pyridoxine hydrochloride) 0.60 mg
Folic Acid 0.02 mg
Vitamin B12 (cyanocobalamin) 0.02 mg
Biotin 0.02 mg
Pantothenic Acid (d-calcium pantothenate) 0.35 mg
Calcium (as chelate) 22.00 mg
Iron (as chelate) 0.23 mg
Phosphorus (as chelate) 14.00 mg
Iodine (from Atlantic 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 (27.72 mg):
Choline Bitartrate, DL-Phenylalanine, Vanadium Chelate, Citrus Bioflavonoids, Inositol, L-Glutamine, L-Methionine, Boron Chelate, Grape Seed Extract, Ginkgo Biloba Leaf, Germanium Sesquioxide, Nickel Chelate
Intervention code [1] 322536 0
Treatment: Other
Comparator / control treatment
The participants will randomly be split into two groups immediately after they completed the baseline period. While individuals allocated to group 1 will start the intervention immediately following the baseline period, individuals allocated to group 2 will have a 4-week delayed start (serving as a waitlist control) and then will proceed as per those assigned to group 1. Participants will be assigned to the groups as soon as they have finished the baseline assessment, and will proceed with their study participation right after they have been assigned, meaning that the individuals won`t go through the study concurrently with members of the same group.
Control group
Active

Outcomes
Primary outcome [1] 330030 0
Revised Clinician-Rated Temper and Irritability Scale (Parent/Child Interview Guide) (CL-ARI). The CL-ARI is a clinician-administered measure that assesses emotion regulation and irritability in children over the past week, asking the parent and child about temper outbursts and irritable mood, including their frequency, severity, and duration. Further, it assesses whether the child’s irritable behaviour causes problems in the family, impairments in school, and assesses potential improvements over time. Final scores range from 0 to 100.
Timepoint [1] 330030 0
Every four weeks, i.e. at baseline, week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2. The primary timepoint is week 20 for group 1 and week 24 for group 2.
Primary outcome [2] 330031 0
Clinical Global Impressions - Improvement Scale (CGI-I). The CGI-I is a clinician-administered scale that rates, based on all information obtained from all raters (parents, child and significant other) how much better/worse the participant is functioning since baseline across mood, stress, anxiety, and energy as well as a global impression. Each item has seven responses, ranging from “very much improved” (1) to “very much worse” (7) and helps to provide a brief, overall assessment of the participant.
Timepoint [2] 330031 0
Every four weeks during the trial in person, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2. The primary timepoint is week 20 for group 1 and week 24 for group 2.
Secondary outcome [1] 404679 0
Clinical Global Impressions – Severity Scale (CGI-S). The CGI-S is a clinician-rated evaluation of symptom severity by means of the question: “Considering your total clinical experience with this particular population, how impaired is the patient at this time?”.
Timepoint [1] 404679 0
At baseline and at the end of each switch point of either (re-)introducing or withdrawing the active intervention.
Secondary outcome [2] 404680 0
Affective Reactivity Index (ARI) (Parent version). The ARI is a concise, parent-rated scale assessing the child’s emotion dysregulation and irritability. It incorporates seven items that ask about feelings of irritability during the past seven days (e.g., “My child is easily annoyed by others”, “My child gets angry frequently”, “Overall, irritability causes my child problems”). How true a statement is can be scored on a 0 (not true) to 2 (certainly true) Likert scale.
Timepoint [2] 404680 0
Screening, baseline, and every two weeks throughout the trial from week 2 to week 20 for group 1 or week 24 for group 2
Secondary outcome [3] 404681 0
Strengths and Difficulties Questionnaire (SDQ). The SDQ consists of 25 items across five subscales, measuring emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior in 4-17 year old children and adolescents over the past six months.
Timepoint [3] 404681 0
At baseline and at week 20 for group 1 and week 24 for group 2
Secondary outcome [4] 404682 0
Adapted Clinical Global Impressions Improvement Scale (CGI-I Parent). The CGI-I Parent represents the parent’s perception of change in their children’s behaviour regarding their mood, anxiety, energy, and global functioning since participating in the trial. Each item has seven responses, ranging from “very much improved” (1) to “very much worse” (7).
Timepoint [4] 404682 0
Every two weeks from week 2 until week 20 for group 1 or week 24 for group 2
Secondary outcome [5] 404683 0
The Child Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV). The child SNAP-IV assesses symptoms of ADHD and oppositional defiant disorder (ODD) in children every 4 weeks. It is a parent- and teacher-rating scale that has three subscales: inattention (item 1-9), hyperactivity-impulsivity (item 10-18), and symptoms of ODD (item 19-26). Each item is assessed from not at all to very much.
Timepoint [5] 404683 0
At baseline and every four weeks throughout the trial, i.e. at baseline, at week 4, 8, 12, 16, 20, for group 1 or week 24 for group 2
Secondary outcome [6] 404684 0
The Children’s Sleep Habits Questionnaire (CSHQ). The CSHQ is a parent-rated measure that assesses sleep in school-aged children. It consists of eight subscales that are both scored individually and make up a total score, identifying sleep problems. In the proposed study, only the total score will be reported, with a score of 41 (larger = more severe) representing the clinical cut-off score for sleep problems. Larger scores indicate more severe sleeping problems.
Timepoint [6] 404684 0
At baseline and every two weeks throughout the trial (from week 2 to week 20 for group 1 or week 24 for group 2
Secondary outcome [7] 404688 0
Parent Target Problem (PTP). The PTP asks the parents to nominate one or two of child's biggest problems, and report on their frequency, duration, impairment, and provide examples. These same 2 problems are reviewed by the clinician at every meeting and assessed for change over time.
Timepoint [7] 404688 0
At baseline and every four weeks throughout the trial, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2
Secondary outcome [8] 404689 0
The Side-Effect Checklist (revised) (ASEC). The ASEC assess side effects, safety and adverse events of the intervention.
Timepoint [8] 404689 0
At baseline and every two weeks throughout the trial, i.e. from week 2 to week 20 for group 1 or week 24 for group 2
Secondary outcome [9] 404690 0
The Measure Yourself Medical Outcome Profile (The MYMOP). Once a month, the research coordinator will meet with the parent and the child to collect information in person regarding the child’s symptoms, including hyperactivity, attention, impulsivity, emotion regulation, irritability, mood, and sleep by means of the MYMOP. Each symptom is scored on a scale from 0 to 5, with a score of 0 representing no problems, whereas a score of 5 indicates that there are lots of problems.
Timepoint [9] 404690 0
At baseline and every four weeks, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2.

Eligibility
Key inclusion criteria
1) Participants must be between 5 and 10 years of age, 2) able to ingest 1 Lightning Stik/day, 3) need to have at least mild-to-moderate levels of emotional dysregulation and irritability based on the Affective-Reactivity-Index (ARI), represented by a total score of 3 or higher.
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Taking psychotropic medications (e.g., Ritalin) in the prior 4 weeks before the trial period, 2) presence of any serious medical or psychiatric condition that might require hospitalisation, 3) any known allergies to the ingredients of the Lightning Stiks.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomised to either group 1 or 2, i.e. to an immediate treatment (group 1) or a waitlist control group (group 2). Randomisation will be determined in blocks of four, where two individual in each block are randomly assigned to group 1, and two to group 2.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will use a two-arm withdrawal open-label design where participants will take the active intervention for four weeks, will be withdrawn from treatment, and will finally take it for another 12 weeks consistently. The participants will be split into two groups. While group 1 will be given one month’s supply of the intervention immediately after the baseline assessment, group 2 will have a delayed four-week start (ie waitlist design) and then will follow the identical protocol as group 1. Every four weeks, participants will meet with the study coordinator to collect data in person regarding emotion dysregulation, irritability, and side effects.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses will be carried out using the software of Lakens (2013) and Cumming (2012), Statistical Package for Social Science (SPSS), Excel, Jamovi, and Sigma Plot. Forty participants will be sought for the study, split 20:20 between group 1 and 2. This number of participants is considered a sufficient sample size to determine whether the intervention is successful in reducing emotion dysregulation with sufficient power. Graphical procedures such as spaghetti plots will be used to examine consistency of individual response over time within the study phases (where there are multiple time points). Modified Brinley Plots (Blampied, 2017) will examine the consistency of patterns of response to treatment and replications of such patterns over study phases. Sigma Plot will be used to examine individual change across time in the context of all other participants’ scores at that time, along with measures of means and SDs. In addition, effect sizes (ES), namely Cohen’s d, the 95%CI on d, and the Common Language ES (CLES; Lakens, 2013) will be reported. The ideographic analysis will also use single-case visual analysis to examine the extent to which there is replication of treatment effects across individuals and replicated phases. Consistency analysis will examine consistency of individual response across primary outcome measures, and baseline demographic variables will be examined using multiple regression and discriminant function analysis to determine if there are predictors of response to treatment. Depending on the characteristics of the sample that will be recruited, demographic and other variables can be explored to identify moderators and other predictors of the treatment response.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
26/08/2022
Actual
Date of last data collection
Anticipated
24/02/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 24470 0
New Zealand
State/province [1] 24470 0
Nationally

Funding & Sponsors
Funding source category [1] 310478 0
University
Name [1] 310478 0
University of Canterbury
Country [1] 310478 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
University of Canterbury
Private Bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 311630 0
Charities/Societies/Foundations
Name [1] 311630 0
UC Foundation
Address [1] 311630 0
Private Bag 4800
Christchurch 8140
Country [1] 311630 0
New Zealand
Secondary sponsor category [2] 311634 0
Charities/Societies/Foundations
Name [2] 311634 0
UC Child Well-being Research Institute
Address [2] 311634 0
Private Bag 4800
Christchurch 8140
Country [2] 311634 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310108 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 310108 0
Ethics committee country [1] 310108 0
New Zealand
Date submitted for ethics approval [1] 310108 0
19/08/2021
Approval date [1] 310108 0
29/11/2021
Ethics approval number [1] 310108 0
21/NTA/169

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

Contacts
Principal investigator
Name 116502 0
Ms Nurina Maria Katta
Address 116502 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 116502 0
New Zealand
Phone 116502 0
+64 220105522
Fax 116502 0
Email 116502 0
nurina.katta@pg.canterbury.ac.nz
Contact person for public queries
Name 116503 0
Nurina Maria Katta
Address 116503 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 116503 0
New Zealand
Phone 116503 0
+64 220105522
Fax 116503 0
Email 116503 0
nurina.katta@pg.canterbury.ac.nz
Contact person for scientific queries
Name 116504 0
Nurina Maria Katta
Address 116504 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 116504 0
New Zealand
Phone 116504 0
+64220105522
Fax 116504 0
Email 116504 0
nurina.katta@pg.canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the small sample size and the relatively small population of New Zealand, it will be too easy to determine the identity of participants from the participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14589Ethical approval    383361-(Uploaded-05-01-2022-01-04-52)-Study-related document.pdf
14590Informed consent form    383361-(Uploaded-05-01-2022-01-04-52)-Study-related document.docx
14593Study protocol    383361-(Uploaded-05-01-2022-01-06-22)-Study-related document.docx



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.