Attention Deficit Disorder With HyperactivityNCT03879343
The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder
An observational study of Attention Deficit Disorder With Hyperactivity and Gastrointestinal Diseases, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
This study is to examine the gut problems in children with attention deficit hyperactivity disorders (ADHD) and is conducted by the Department of Psychiatry of Alice Ho Miu Ling Nethersole Hospital. Children with ADHD who attend our department will be recruited with their parents/guardians' consent. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Gastrointestinal Diseases
- What is being tested?
- Known diagnosis of attention deficit / hyperactivity disorder
- How many people
- 142 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will recruit children who attend a local district child and adolescent psychiatry outpatient department during the study period. A consecutively selected sample of participants is recruited until it reaches the target number of sample size. The normal controls will be recruited via primary schools.
Who may be able to join
- The study group will be recruited if the following criteria are met:
- Aged 6 to 11 years old
- Children with a diagnosis of ADHD made by psychiatrists according to Diagnostic and Statistical Manual for Mental Disorder, fifth edition criteria
- Currently study in mainstream schools in Hong Kong
- The control group will be recruited if the following criteria are met:
- Age 6 to 11 years old
- Currently study in mainstream schools in Hong Kong
- Typically developing in good mental and physical health
Who cannot join
- For both groups, the participant will be excluded if the following criterion is met:
- Children who are suffering from mental retardation
- Children who are suffering from organic illnesses that affect gastrointestinal function
- Children who are suffering from severe mental illnesses
- Children who have ever received, or are currently on, medication for ADHD
- Children who are currently taking medication for illnesses other than ADHD
- Primary caregiver does not understand Chinese
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Alice Ho Miu Ling Nethersole Hospital
Tai Po, New Territories
About this study
This study is to examine the gut problems in children with attention deficit hyperactivity disorders (ADHD) and is conducted by the Department of Psychiatry of Alice Ho Miu Ling Nethersole Hospital. Children with ADHD who attend our department will be recruited with their parents/guardians' consent. Only the primary caregiver will be invited for an interview to assess the recruited children's gut problems, autistic features, emotional problems, diet pattern and medical history. The data will be compared with normal children who are recruited as control in local primary schools. The aim of this study is to know whether children with ADHD have higher chance of gut problems, and to assess other factors associated with the linkage.
- Being tested
- Known diagnosis of attention deficit / hyperactivity disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Known diagnosis of attention deficit / hyperactivity disorderOther
Clinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder
| Study group | Role | What they receive |
|---|---|---|
| Clinical group | Children aged six to eleven with clinical diagnosis of attention deficit / hyperactivity disorder were recruited for interview and completion of questionnaires Receives: Other: Known diagnosis of attention deficit / hyperactivity disorder | |
| Control group | Normally developing children aged six to eleven studying in local mainstream primary schools were recruited for completion of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of children with ADHD had gastrointestinal (GI) symptoms
Functional gastrointestinal symptoms as measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PGD)
Measured: One month prior to interview
Secondary outcomes (1)
The number of children with ADHD had GI symptoms after controlling for the potential confounding factors including co-morbid autism spectrum disorder (ASD) symptoms, emotional symptoms and diet pattern
Measured: One month prior to interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, NG SIU FUNG JONATHAN, Hospital Authority, Hong Kong
- Investigators
- Jonathan Siu Fung Ng, Principal investigator, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879343
- Sponsor's protocol ID
- 2018.285
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2019
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03879343
- Acronym / sponsor ID
- 2018.285
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to examine the gut problems in children with attention deficit hyperactivity disorders (ADHD) and is conducted by the Department of Psychiatry of Alice Ho Miu Ling Nethersole Hospital. Children with ADHD who attend our department will be recruited with their parents/guardians' consent. Only the primary caregiver will be invited for an interview to assess the recruited children's gut problems, autistic features, emotional problems, diet pattern and medical history. The data will be compared with normal children who are recruited as control in local primary schools. The aim of this study is to know whether children with ADHD have higher chance of gut problems, and to assess other factors associated with the linkage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical group | – | Other: Known diagnosis of attention deficit / hyperactivity disorderChildren aged six to eleven with clinical diagnosis of attention deficit / hyperactivity disorder were recruited for interview and completion of questionnaires |
| Control group | – | –Normally developing children aged six to eleven studying in local mainstream primary schools were recruited for completion of questionnaires |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will recruit children who attend a local district child and adolescent psychiatry outpatient department during the study period. A consecutively selected sample of participants is recruited until it reaches the target number of sample size. The normal controls will be recruited via primary schools.
Key inclusion criteria (8 listed)
- The study group will be recruited if the following criteria are met:
- Age 6 to 11 years old
- Currently study in mainstream schools in Hong Kong
- Typically developing in good mental and physical health
Key exclusion criteria (7 listed)
- For both groups, the participant will be excluded if the following criterion is met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Known diagnosis of attention deficit / hyperactivity disorderClinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder | Other | Clinical group |
Primary outcome
The number of children with ADHD had gastrointestinal (GI) symptoms
Time frame: One month prior to interview
Functional gastrointestinal symptoms as measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PGD)
1 secondary outcome
The number of children with ADHD had GI symptoms after controlling for the potential confounding factors including co-morbid autism spectrum disorder (ASD) symptoms, emotional symptoms and diet pattern
Time frame: One month prior to interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Siu Fung Ng principal investigator
Hospital Authority, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity and Gastrointestinal Diseases, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of children with ADHD had gastrointestinal (GI) symptoms (time frame: One month prior to interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.