NCT00046059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2000

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2000

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2002

Completed
16.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

19 years

First QC Date

September 18, 2002

Last Update Submit

December 19, 2024

Conditions

Keywords

LinkageGene IdentificationHyperactivityNatural HistoryAttention Deficit Hyperactivity DisorderADHD

Outcome Measures

Primary Outcomes (1)

  • 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.

    Ongoing

Study Arms (1)

ADHD

Children aged 7-17 with ADHD and their families.

Eligibility Criteria

Age7 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1\. Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study). 2. The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings. 3. The parents, both mothers and fathers, of enrolled probands.

You may qualify if:

  • This study will enroll families with the following characteristics:
  • Families with children, seven through 17 years of age, diagnosed with ADHD (defined as the proband for the study).
  • The probands siblings, either affected with ADHD (concordant) or unaffected (discordant), seven years of age and above, including adult siblings.
  • The parents, both mothers and fathers, of enrolled probands.
  • The study will enroll both male and female probands of any ethnic background and race. The prevalence of ADHD is higher in males than in females, so we would expect to have a higher number of male probands than female probands. Both male and female siblings and male and female parents of probands will be enrolled.
  • Adults who are or may be unable to provide informed consent will be excluded.
  • Probands with one parent affected with ADHD or with neither parent affected with ADHD are eligible. Probands from bilineal families, families with both parents affected with ADHD, will be excluded for statistical reasons.
  • \. Ability to read and understand spoken English, since the questionnaires, scales, and interviews that we have license to use in this study are in English.

You may not qualify if:

  • 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:
  • Prematurity
  • Neurological conditions
  • Cardiac surgery
  • Prenatal drug exposure
  • Hydrocephaly
  • Mental Retardation (IQ\<80)
  • Known genetic syndromes
  • Known CNS disorders
  • Known lead toxicity
  • Tourette Disorder
  • Obsessive-Compulsive Disorder
  • Major Depression on both proband and affected sibling
  • Pervasive Developmental Disorder
  • Age under 7 years old
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Irvine Medical Center

Orange, California, 92668, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.

    PMID: 2432848BACKGROUND
  • Biederman J, Faraone S, Milberger S, Guite J, Mick E, Chen L, Mennin D, Marrs A, Ouellette C, Moore P, Spencer T, Norman D, Wilens T, Kraus I, Perrin J. A prospective 4-year follow-up study of attention-deficit hyperactivity and related disorders. Arch Gen Psychiatry. 1996 May;53(5):437-46. doi: 10.1001/archpsyc.1996.01830050073012.

    PMID: 8624187BACKGROUND
  • Faraone SV, Biederman J, Chen WJ, Milberger S, Warburton R, Tsuang MT. Genetic heterogeneity in attention-deficit hyperactivity disorder (ADHD): gender, psychiatric comorbidity, and maternal ADHD. J Abnorm Psychol. 1995 May;104(2):334-345. doi: 10.1037/0021-843X.104.2.334.

    PMID: 7790635BACKGROUND

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria T Acosta, M.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2002

First Posted

September 19, 2002

Study Start

February 8, 2000

Primary Completion

January 30, 2019

Study Completion

January 24, 2020

Last Updated

December 24, 2024

Record last verified: 2024-12

Locations