Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Mass General Brigham

Status: Terminated

Conditions: Pediatric ADHD

Study type: Observational

Funder types: Other

Identifiers

NCT00592436

2003-P-000239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 663 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No 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

Trial design

663 participants in 1 patient group

1