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The Feasibility of a Dietary Intervention in Children With ADHD

Primary Purpose

ADHD, Diet Modification

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diet modification
Sponsored by
St Mary's University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ADHD focused on measuring ADHD, Diet Modification

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Mary's University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diet modification

Arm Description

Outcomes

Primary Outcome Measures

Completion of study
What proportion of participants completed the study?

Secondary Outcome Measures

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).
Side-effects
Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
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
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
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
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.
The Consensus Sleep Diary
Record of sleep - used qualitatively to detect and remove artefacts from the data.
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.
Sleep self-report questionnaire
Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties).
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.
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.
Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing
Analysis of bacterial strains and diversity within stool sample
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)

Full Information

First Posted
November 8, 2018
Last Updated
June 5, 2019
Sponsor
St Mary's University College
Collaborators
Goldsmiths, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT03737877
Brief Title
The Feasibility of a Dietary Intervention in Children With ADHD
Official Title
The Feasibility of a Microbiome Dietary Intervention in Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Mary's University College
Collaborators
Goldsmiths, University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Diet Modification
Keywords
ADHD, Diet Modification

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet modification
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diet modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of study
Description
What proportion of participants completed the study?
Time Frame
final week
Secondary Outcome Measure Information:
Title
Adherence to diet
Description
Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence).
Time Frame
week 6 of diet
Title
Side-effects
Description
Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome).
Time Frame
duration of the 6 week diet
Title
The Conners Clinical Index (Conners CI) - Parent-report
Description
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
Time Frame
Baseline and week 6 of diet
Title
The Conners Clinical Index (Conners CI) - Teacher-report
Description
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
Time Frame
Baseline and week 6 of diet
Title
The Conners Clinical Index (Conners CI) - Self-report
Description
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
Time Frame
Baseline and week 6 of diet
Title
Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected).
Description
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.
Time Frame
Baseline and week 6 of diet
Title
The Consensus Sleep Diary
Description
Record of sleep - used qualitatively to detect and remove artefacts from the data.
Time Frame
Baseline and week 6 of diet
Title
Children's Sleep Habits Questionnaire
Description
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.
Time Frame
Baseline and week 6 of diet
Title
Sleep self-report questionnaire
Description
Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties).
Time Frame
Baseline and week 6 of diet
Title
Actigraphy recordings
Description
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.
Time Frame
Baseline and week 6 of diet
Title
The Gastrointestinal Symptom Rating
Description
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.
Time Frame
Baseline and week 6 of diet
Title
Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing
Description
Analysis of bacterial strains and diversity within stool sample
Time Frame
Baseline and week 6 of diet
Title
Treatment Acceptability Scale
Description
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)
Time Frame
Baseline and week 6 of diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Mary's University
City
London
ZIP/Postal Code
TW14SX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
At the request of individual researchers.
Citations:
PubMed Identifier
35606889
Citation
Lawrence K, Myrissa K, Toribio-Mateas M, Minini L, Gregory AM. Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study. Pilot Feasibility Stud. 2022 May 23;8(1):108. doi: 10.1186/s40814-022-01058-4.
Results Reference
derived

Learn more about this trial

The Feasibility of a Dietary Intervention in Children With ADHD

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