Attention-Deficit Hyperactivity DisorderNCT00339729
Johnston County ADHD Study: Environmental, Reporductive, and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)
An observational study of Attention-Deficit Hyperactivity Disorder, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 1997to 24 May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- During the first phase of the study, all children will be screened by the homeroom teacher, EXCEPT for those students in certain self-contained classrooms. Self-contained classrooms for students with an IQ less than 70 or autism will be omitted from the screening. In the second phase of the study, children designated as "LEP", or Low English Proficiency, will be excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: Johnston County ADHD Study: Environmental, Reproductive and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
Read the detailed description
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
- Conditions
- Attention-Deficit Hyperactivity Disorder
- Keywords
- Children, Behavior, Epidemiology, Lead, Learning Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Behavior, Learning Disabilities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 May 1997
- Study completion24 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 8,000 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339729
- Sponsor's protocol ID
- 999997029
- Other IDs
- OH97-E-N029
- Status last verified
- 24 May 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Johnston County ADHD Study: Environmental, Reproductive and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00339729
- Acronym / sponsor ID
- 999997029
- Conditions
- Attention-Deficit Hyperactivity Disorder
- Keywords
- Children, Behavior, Epidemiology, Lead, Learning Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 7 May 1997
- Study completion
- 24 May 2007
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
Detailed description
We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.
Study design
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- During the first phase of the study, all children will be screened by the homeroom teacher, EXCEPT for those students in certain self-contained classrooms. Self-contained classrooms for students with an IQ less than 70 or autism will be omitted from the screening. In the second phase of the study, children designated as "LEP", or Low English Proficiency, will be excluded from the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit Hyperactivity Disorder, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.