Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00592436

Enrollment

663

Registered

2008-01-14

Start date

2003-03-31

Completion date

2015-05-31

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric ADHD

Keywords

ADHD, pediatric, children

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Screening Protocol	Screening	This is a prescreening for potential participation in research studies.

Countries

United States

Outcome results