Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Terminated

• Conditions: Pediatric ADHD

• Registration Number: NCT00592436
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-14
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 663

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening Protocol	Screening	This is a prescreening for potential participation in research studies.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States