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

NCT03879343 | Completed DMC

• 1 other identifier: 2018.285
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Attention Deficit Disorder With Hyperactivity; Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 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

  One month prior to interview

Study Arms (2)

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

Control group

Normally developing children aged six to eleven studying in local mainstream primary schools were recruited for completion of questionnaires

Interventions

Known diagnosis of attention deficit / hyperactivity disorder OTHER

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

Clinical group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Tai Po, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Digestive System Diseases

Study Officials

• Jonathan Siu Fung Ng

  Hospital Authority, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: July 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

HK (1)