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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00181857
Other study ID # 2004-P-002687
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated October 30, 2013
Start date February 2005
Est. completion date February 2008

Study information

Verified date October 2013
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 2008
Est. primary completion date February 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Must be a biological child of an ADHD NOS proband. The proband must meet the following criterion:

1. Age: above 18 years

2. Sex: male or female

3. Intelligence quotient (IQ) above 80

4. 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

- 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.

5. Had a Clinical Global Impression: ADHD score of 4 (moderately ill) or higher illness severity at a clinical evaluation.

6. Has at least one biological offspring

Exclusion Criteria:

1. No adequate informant is available to answer the survey questions.

2. 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.)

3. Psychosis, autism, schizophrenia.

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ADHD Diagnosis at evaluation No
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