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

• ClinicalTrials.gov Identifier: NCT03879343
• Recruitment Status: Unknown
• First Posted: March 18, 2019
• Last Update Posted: March 19, 2019
• Sponsor: Hospital Authority, Hong Kong
• Collaborator: Chinese University of Hong Kong
• Information provided by (Responsible Party): NG SIU FUNG JONATHAN, Hospital Authority, Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment
Attention Deficit Disorder With Hyperactivity; Gastrointestinal Diseases	Other: Known diagnosis of attention deficit / hyperactivity disorder

Study Design

• Study Type: Observational
• Estimated Enrollment: 137 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Prevalence and Predictors of Gastrointestinal Symptoms in Children With Attention Deficit / Hyperactivity Disorder
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: July 2019
• Estimated Study Completion Date: July 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Jonathan Siu Fung Ng; 852 26892000; nsf600@ha.org.hk

Locations

Hong Kong

Alice Ho Miu Ling Nethersole Hospital; Recruiting

Tai Po, New Territories, Hong Kong

Contact: Jonathan Siu Fung Ng 852 26892000 nsf600@ha.org.hk

Sponsors and Collaborators

Hospital Authority, Hong Kong

Chinese University of Hong Kong

Investigators

• Principal Investigator: Jonathan Siu Fung Ng; Hospital Authority, Hong Kong

More Information

• Responsible Party: NG SIU FUNG JONATHAN, Principal investigator, Hospital Authority, Hong Kong
• ClinicalTrials.gov Identifier: NCT03879343
• Other Study ID Numbers: 2018.285
• First Posted: March 18, 2019
• Last Update Posted: March 19, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastrointestinal Diseases; Digestive System Diseases; Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases