The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder

NCT ID: NCT03879343

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity Gastrointestinal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinical group

Children aged six to eleven with clinical diagnosis of attention deficit / hyperactivity disorder were recruited for interview and completion of questionnaires

Known diagnosis of attention deficit / hyperactivity disorder

Intervention Type OTHER

Clinical group includes subjects with clinical 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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Known diagnosis of attention deficit / hyperactivity disorder

Clinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The study group will be recruited if the following criteria are met:

1. Aged 6 to 11 years old
2. Children with a diagnosis of ADHD made by psychiatrists according to Diagnostic and Statistical Manual for Mental Disorder, fifth edition criteria
3. Currently study in mainstream schools in Hong Kong

The control group will be recruited if the following criteria are met:

1. Age 6 to 11 years old
2. Currently study in mainstream schools in Hong Kong
3. Typically developing in good mental and physical health

Exclusion Criteria

* For both groups, the participant will be excluded if the following criterion is met:

1. Children who are suffering from mental retardation
2. Children who are suffering from organic illnesses that affect gastrointestinal function
3. Children who are suffering from severe mental illnesses
4. Children who have ever received, or are currently on, medication for ADHD
5. Children who are currently taking medication for illnesses other than ADHD
6. Primary caregiver does not understand Chinese
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NG SIU FUNG JONATHAN

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Siu Fung Ng

Role: PRINCIPAL_INVESTIGATOR

Hospital Authority, Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alice Ho Miu Ling Nethersole Hospital

Tai Po, New Territories, Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018.285

Identifier Type: -

Identifier Source: org_study_id