The Feasibility of a Dietary Intervention in Children With ADHD

Not Applicable

• Conditions: ADHD; Diet Modification
• Interventions: Other: Diet modification

• Registration Number: NCT03737877
• Lead Sponsor: St Mary's University College

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Study Start: 2019-05-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Parent-reported diagnosis of ADHD.
2. Children aged between 8 years - 13 years 11 months at onset of study.
3. Children not taking ADHD medication (such as methylphenidate) at the time of the study.
4. Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments.
5. Both males and females are eligible to take part.
6. Children with a co-occurring diagnosis will be accepted onto the trial.
7. Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.

Exclusion Criteria

1. Children undergoing a current course of behavioural therapy.
2. Children currently on ADHD medication (such as methylphenidate).
3. Children who have taken antibiotics in the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet modification	Diet modification	-

Primary Outcome Measures

Name	Time	Method
Completion of study	final week	What proportion of participants completed the study?

Secondary Outcome Measures

Name	Time	Method
Side-effects	duration of the 6 week diet	Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
Adherence to diet	week 6 of diet	Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence).
The Conners Clinical Index (Conners CI) - Parent-report	Baseline and week 6 of diet	Parental report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms); 1. Disruptive Behavior Indicator; 2. Learning and Language Disorder Indicator; 3. Mood Disorder Indicator; 4. Anxiety Disorder Indicator; 5. ADHD Indicator
The Conners Clinical Index (Conners CI) - Teacher-report	Baseline and week 6 of diet	Teacher report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms); 1. Disruptive Behavior Indicator; 2. Learning and Language Disorder Indicator; 3. Mood Disorder Indicator; 4. Anxiety Disorder Indicator; 5. ADHD Indicator
The Consensus Sleep Diary	Baseline and week 6 of diet	Record of sleep - used qualitatively to detect and remove artefacts from the data.
Children's Sleep Habits Questionnaire	Baseline and week 6 of diet	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.
Sleep self-report questionnaire	Baseline and week 6 of diet	Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties).
Actigraphy recordings	Baseline and week 6 of diet	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.
The Gastrointestinal Symptom Rating	Baseline and week 6 of diet	Questionnaire to evaluate common gastrointestinal symptoms Total scores range from 15-105 (with higher scores reflecting more/more severe gastrointestinal symptoms).; Subscales: 1. Abdominal pain (abdominal pain, hunger pains and nausea). Range 3-21 - a high score reflects worse symptoms.; 2. Reflux syndrome (heartburn and acid regurgitation). Range 3-21 - a high score reflects worse symptoms.; 3. Diarrhoea syndrome (diarrhoea, loose stools and urgent need for defecation). Range 3-21 - a high score reflects worse symptoms.; 4. 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.; 5. Constipation syndrome (constipation, hard stools and feeling of incomplete evacuation). Range 3-21 - a high score reflects worse symptoms.
Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing	Baseline and week 6 of diet	Analysis of bacterial strains and diversity within stool sample
The Conners Clinical Index (Conners CI) - Self-report	Baseline and week 6 of diet	Child self-report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms); 1. Disruptive Behavior Indicator; 2. Learning and Language Disorder Indicator; 3. Mood Disorder Indicator; 4. Anxiety Disorder Indicator; 5. ADHD Indicator
Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).	Baseline and week 6 of diet	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.
Treatment Acceptability Scale	Baseline and week 6 of diet	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)

Trial Locations

Locations (1)

St Mary's University; 🇬🇧 London, United Kingdom