Completed

Understanding Gastrointestinal Conditions in Children With ASD

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What is being collected

Data Collection

Other
Who is being recruted

Mental Disorders+4

+ Child Development Disorders, Pervasive

+ Digestive System Diseases

From 2 to 17 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2008
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: August 30, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2008

Actual date on which the first participant was enrolled.

The purpose of this research study is to help us learn if children with Autism Spectrum Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than children without ASD do. The investigators hope to learn if children with ASD and gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and aggression, more than children with ASD but no GI disorders do. The investigators want to learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children with ASD also have gastrointestinal disorders. Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not identified by current diagnostic evaluation. Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing children. The investigators anticipate that the proposed study will raise the standard of medical care for children with ASD by improving current methods of identifying GI dysfunction and determining whether there is a significant relationship between GI dysfunction and PB in this population.

Principal SponsorMassachusetts General Hospital
Last updated: August 30, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

131 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersChild Development Disorders, PervasiveDigestive System DiseasesNeurodevelopmental DisordersAutism Spectrum DisorderAutistic DisorderGastrointestinal Diseases

Criteria

2 inclusion criteria required to participate
Children who are ATN Registry subjects between 2 and 17 years old (inclusive)

Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an established ATN center within the last 18 months

1 exclusion criteria prevent from participating
Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic disorders (e.g. Fragile X, Down syndrome, etc.)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

LADDERS, Massachusetts General Hospital

Boston, United StatesOpen LADDERS, Massachusetts General Hospital in Google Maps
CompletedOne Study Center