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Completed

NCT Number: NCT03879343

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, New Territories, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Known diagnosis of attention deficit / hyperactivity disorder

Other

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

Primary outcomes

  1. 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)

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

    Time frame: One month prior to interview

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • Chinese University of Hong Kong

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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