The Feasibility of a Dietary Intervention in Children With ADHD

Study Overview
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Brief Summary
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The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Detailed Description
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Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Research suggests dietary manipulations may be a helpful treatment option for children with ADHD, although the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria in individuals with ADHD may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. We propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Official Title
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The Feasibility of a Microbiome Dietary Intervention in Children With ADHD

Conditions
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ADHD, Diet Modification

Intervention / Treatment
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* Other: Diet modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent-reported diagnosis of ADHD. Children aged between 8 years - 13 years 11 months at onset of study. Children not taking ADHD medication (such as methylphenidate) at the time of the study. Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments. Both males and females are eligible to take part. Children with a co-occurring diagnosis will be accepted onto the trial. Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial. Exclusion Criteria: Children undergoing a current course of behavioural therapy. Children currently on ADHD medication (such as methylphenidate). Children who have taken antibiotics in the past 3 months

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet modification<br> | Other: Diet modification<br>* The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles: Eat at least seven portions of different varieties of fruit and vegetables each day. Have a 12 hour overnight break from food (water only during this time). Drink a Kefir drink each day - provided free of charge. Eat a microbiome friendly, protein rich, breakfast from our menu. Reduce sugar and artificial sweeteners.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of study | What proportion of participants completed the study? | final week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to diet | Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence). | week 6 of diet | 
| Side-effects | Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome). | duration of the 6 week diet | 
| The Conners Clinical Index (Conners CI) - Parent-report | Parental report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) Disruptive Behavior Indicator Learning and Language Disorder Indicator Mood Disorder Indicator Anxiety Disorder Indicator ADHD Indicator | Baseline and week 6 of diet | 
| The Conners Clinical Index (Conners CI) - Teacher-report | Teacher report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) Disruptive Behavior Indicator Learning and Language Disorder Indicator Mood Disorder Indicator Anxiety Disorder Indicator ADHD Indicator | Baseline and week 6 of diet | 
| The Conners Clinical Index (Conners CI) - Self-report | Child self-report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) Disruptive Behavior Indicator Learning and Language Disorder Indicator Mood Disorder Indicator Anxiety Disorder Indicator ADHD Indicator | Baseline and week 6 of diet | 
| Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected). | Computerised test of visual working memory DMS Percent Correct (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-100% - higher score reflects greater accuracy. DMS Mean & Median Correct Latency (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-∞ ms - higher score reflects worse performance. DMS Correct Latency Standard Deviation. Range 0-∞ ms - higher score reflects worse performance. DMS Mean Choices to Correct response. Range 0-4 - higher score reflects worse performance. DMS Probability of Error Given Error. Range 0-1 - higher score reflects worse performance. | Baseline and week 6 of diet | 
| The Consensus Sleep Diary | Record of sleep - used qualitatively to detect and remove artefacts from the data. | Baseline and week 6 of diet | 
| Children's Sleep Habits Questionnaire | Parental report of child's sleep A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A higher score indicates more problematic sleep. | Baseline and week 6 of diet | 
| Sleep self-report questionnaire | Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties). | Baseline and week 6 of diet | 
| Actigraphy recordings | Objective measure of sleep quality and daytime activity Mean activity during sleep. Range 0-∞. A higher score = less sound sleep (worse). Minutes spent awake during the down period. Range 0-∞. A higher score = less sound sleep (worse). Sleep latency (time taken to fall asleep). Range 0-∞. A higher score = more time taken to fall asleep (worse). Sleep efficiency (% down period spent asleep, after removing sleep latency). A higher score = better. Wake after sleep onset (minutes spent awake during the down period after removing sleep latency). Range 0-∞. A higher score = less sound sleep (worse). Sleep fragmentation (number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse). Mean daytime activity (0-∞) not necessarily worse or better. | Baseline and week 6 of diet | 
| The Gastrointestinal Symptom Rating | Questionnaire to evaluate common gastrointestinal symptoms Total scores range from 15-105 (with higher scores reflecting more/more severe gastrointestinal symptoms). Subscales: Abdominal pain (abdominal pain, hunger pains and nausea). Range 3-21 - a high score reflects worse symptoms. Reflux syndrome (heartburn and acid regurgitation). Range 3-21 - a high score reflects worse symptoms. Diarrhoea syndrome (diarrhoea, loose stools and urgent need for defecation). Range 3-21 - a high score reflects worse symptoms. Indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus). Range 3-21 - a high score reflects worse symptoms. Range 3-21 - a high score reflects worse symptoms. Constipation syndrome (constipation, hard stools and feeling of incomplete evacuation). Range 3-21 - a high score reflects worse symptoms. | Baseline and week 6 of diet | 
| Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing | Analysis of bacterial strains and diversity within stool sample | Baseline and week 6 of diet | 
| Treatment Acceptability Scale | Questionnaire to assess the acceptability of the diet to parents of the children taking part in the study Score range 6-42 (High score reflects more positive attitude to treatment) | Baseline and week 6 of diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Diet Modification