ADHDNCT00181857
Risk of Attention Deficit Hyperactivity Disorder (ADHD) in the Children of Adults With ADHD Not Otherwise Specified (NOS)
An observational study of ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The researchers plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ADHD
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Feb 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Children of Adults with ADHD NOS
Who may be able to join
- Must be a biological child of an ADHD NOS proband. The proband must meet the following criterion:
- Age: above 18 years
- Sex: male or female
- Intelligence quotient (IQ) above 80
- Met criteria for the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
- having at least 6 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity but < 5 items from either list in childhood, or
Show all 9Show fewer
- having 5 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity, but not having the 6 current symptoms in either category. This second category will be included independent of the presence or absence of ADHD symptoms in childhood.
- Had a Clinical Global Impression: ADHD score of 4 (moderately ill) or higher illness severity at a clinical evaluation.
- Has at least one biological offspring
Who cannot join
- No adequate informant is available to answer the survey questions.
- Sensorimotor deficits. (These include deficits that would impede the survey process, e.g. profound deafness, blindness, inadequate command of the English language, or profound disorders of language.)
- Psychosis, autism, schizophrenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Risk of Attention Deficit Hyperactivity Disorder in the Children of Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified: A Pilot Study
The researchers plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. The researchers hypothesize that the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.
Read the detailed description
We plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. We hypothesize the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.
The proposed study includes a one-time fifteen minute survey derived from the ADHD module of the Kiddie Schedule for Affective Disorders - Epidemiological Version (KSADS-E) with the proband of an ADHD NOS study regarding his/her children, in order to assess possible ADHD symptoms of that child. We also ask "school questions" regarding certain aspects of a child's educational experience.
- Conditions
- ADHD
- Keywords
- ADHD NOS, familial risk, children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children of Adults with ADHD NOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Diagnosis
Measured: at evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig B. Surman, MD, Massachusetts General Hospital
- Investigators
- Craig Surman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181857
- Sponsor's protocol ID
- 2004-P-002687
- Status last verified
- Oct 2013
- First submitted
- 13 Sep 2005
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Attention Deficit Hyperactivity Disorder in the Children of Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified: A Pilot Study
- ClinicalTrials.gov ID
- NCT00181857
- Acronym / sponsor ID
- 2004-P-002687
- Conditions
- ADHD
- Keywords
- ADHD NOS, familial risk, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Sep 2005 (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.
The researchers plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. The researchers hypothesize that the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.
Detailed description
We plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. We hypothesize the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.
The proposed study includes a one-time fifteen minute survey derived from the ADHD module of the Kiddie Schedule for Affective Disorders - Epidemiological Version (KSADS-E) with the proband of an ADHD NOS study regarding his/her children, in order to assess possible ADHD symptoms of that child. We also ask "school questions" regarding certain aspects of a child's educational experience.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children of Adults with ADHD NOS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Children of Adults with ADHD NOS
Key inclusion criteria (9 listed)
- Must be a biological child of an ADHD NOS proband. The proband must meet the following criterion:
- Age: above 18 years
- Sex: male or female
- Intelligence quotient (IQ) above 80
- Met criteria for the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
Key exclusion criteria (3 listed)
- No adequate informant is available to answer the survey questions.
- Sensorimotor deficits. (These include deficits that would impede the survey process, e.g. profound deafness, blindness, inadequate command of the English language, or profound disorders of language.)
- Psychosis, autism, schizophrenia.
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
ADHD Diagnosis
Time frame: at evaluation
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 31 Oct 2013.
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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.
Craig Surman, MD principal investigator
Massachusetts General Hospital
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 ADHD, run by Massachusetts General Hospital 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 9 inclusion and 3 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 31 Oct 2013. 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.
What does the primary outcome measure?
ADHD Diagnosis (time frame: at evaluation). It is what the study was designed to measure, not a finding.
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 31 Oct 2013.