NCT00711724

Brief Summary

The primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

1.7 years

First QC Date

July 3, 2008

Last Update Submit

June 21, 2010

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)Adolescent

Outcome Measures

Primary Outcomes (1)

  • The ADHD-RS and ASRS v1.1 Symptom Checklist scales

    Weeks 1, 2, 3, 4, 5, 6, 7, or 8

Study Arms (1)

MGH 1

Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who are enrolled in the study Protocol 2003-P-001313: "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA."

You may qualify if:

  • Diagnosis of ADHD
  • Age 13-65\* \*Parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the MGH site)

You may not qualify if:

  • Inability to reliably report ADHD symptoms at the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Paul Hammerness, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 23, 2010

Record last verified: 2010-06

Locations

US(1)