Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

663 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2015-05-31

Brief Summary

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The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.

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Detailed Description

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The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Conditions

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Pediatric ADHD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Males and females ages 6-17
2. Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child

Exclusion Criteria

1. History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
2. Any significant medical condition, in the judgment of the investigator
3. Mental retardation
4. Pregnancy or lactation
5. Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
6. Sensory difficulties such as deafness or blindness

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No