An observational study in ADHD, sponsored by National Human Genome Research Institute (NHGRI). Completed at 2 sites in United States. Open to participants aged 7 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by National Human Genome Research Institute (NHGRI) · Observational
Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioral disorder in childhood, affecting 3-5% of children between the ages of 7 and 17. Family studies suggest that there is a genetic component to ADHD. Scientists believe that it is a complex disorder in which two or more genes may be involved.
Potentially eligible families will be asked to give written consent to participate and will be asked to complete questionnaires for each member in the family. In addition, an interview will be administered to the parent of minors enrolled in the study to determine their eligibility for being in the study. This screening tool is computerized and will take approximately 45 minutes to administer per child.
Once screenings are completed, a blood collection kit will be sent to the family to take to their local medical care provider, have blood samples drawn and sent to NIH. There is no cost to the family to participate. We would like to enroll entire families, with both parents and all children.
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common childhood
disorders and the most common childhood neurodevelopmental behavioral disorder. Symptoms include difficulty staying focused (inattention), difficulty controlling behavior (impulsivity), and hyperactivity. Symptoms typically develop between six and 12 years of age, and frequently persist into adulthood, with serious life-long health and social consequences. Affected children are at increased risk for poor educational achievement, low income, underemployment, legal difficulties, and impaired social relationships. The general belief is that ADHD is caused by a combination of genetic and environmental factors.
The main objective of the study is to conduct genetic and behavioral studies that will closely
characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological
response in ADHD patients. Since the start of the study in 2000, research has contributed to the understanding of the innate susceptibility of ADHD and associated comorbidities; the interaction of genetic, demographic, and environmental factors underpinning the risk of developing ADHD; the extent to which these factors shape the response of ADHD patients to pharmacological interventions (pharmacogenetics); the over-representation of functional and ontological genebased networks implicated in determining synapse structure; and the use of advanced geneticepidemiological models with potential for use in clinical practice (translational genomics). The most significant research finding occurred in 2010, when the study team identified LPHN3, a key gene involved in the etiology of ADHD and comorbid conditions in one of the previously identified regions of strong genetic signal in chromosome 4q13.2.
In order to provide power for the study s statistical analyses, the upper enrollment goal is 4,000 participants. Although the study has several small and genetically distinct cohorts, the majority of subjects come from the United States of America population through outreach recruitment efforts. Recruitment has been very successful and the large cohort numbers provide support for identification of genetic components related to the diagnosis of ADHD. Recent efforts have focused on identifying new areas of the genome associated with ADHD, and identifying genetic (coding and non-coding) variations implicated in the etiology and clinical manifestations of ADHD. A primary aim of the study is to correlate genetic and biological markers for diagnosis and prognosis of ADHD identified through the use of state of the art genomics, which includes enome-wide association studies, linkage analysis, whole genome and exome sequencing, and targeted gene capture in cosmopolitan and isolated populations. As the current diagnosis of ADHD is based on subjective observations, one of the main goals of the study is to develop a more definitive system to diagnose ADHD and to assess and predict prognosis.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 3,481 is above the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
This study will enroll families with the following characteristics:
Additional inclusion criteria for the study include:
EXCLUSION CRITERIA:
Some conditions can confound the diagnosis of ADHD. Probands with the following conditions will be excluded from enrollment or will be withdrawn from the study if the condition is discovered subsequent to enrollment:
Probands with the following conditions may be included, but the conditions will be noted during statistical analysis:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 7-17 with ADHD and their families.
ADHD
The main objective of the study is to conduct genetic and behavioral studies that will closely characterize the genetic influences in diagnosis, prognosis, severity, and pharmacological response in ADHD patients.
Time frame: Ongoing
Plan to share: Undecided — pending
Ran from Feb 2000 to primary completion in Jan 2019, 227 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity →
National Human Genome Research Institute (NHGRI) →