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

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 Overview

• Status: Unknown
• Conditions: Gastrointestinal Diseases; Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Other: Known diagnosis of attention deficit / hyperactivity disorder

• Study Type: Observational
• Enrollment (Anticipated): 137

Contacts and Locations

• Study Contact: Name: Jonathan Siu Fung Ng; Phone Number: 852 26892000; Email: nsf600@ha.org.hk

Study Locations

• Hong Kong
  • New Territories
    • Tai Po, New Territories, Hong Kong
      • Recruiting
      • Alice Ho Miu Ling Nethersole Hospital
      • Contact: Jonathan Siu Fung Ng; Phone Number: 852 26892000; Email: nsf600@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinical group; Children aged six to eleven with clinical diagnosis of attention deficit / hyperactivity disorder were recruited for interview and completion of questionnaires	Other: Known diagnosis of attention deficit / hyperactivity disorder; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One month prior to interview

Secondary Outcome Measures

Outcome Measure	Time Frame
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	One month prior to interview

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Jonathan Siu Fung Ng, Hospital Authority, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Gastrointestinal Diseases; Digestive System Diseases; Hyperkinesis
• Other Study ID Numbers: 2018.285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No