Trial record 7 of 668 for:    adolescent health | Open Studies

Initial Validation of the Vanderbilt ADHD Measure for Adolescent Patients in the ICISS Project

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Joshua Borus, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01964209
First received: October 10, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

This proposal is to evaluate the reliability and validity of the Vanderbilt ADHD screening tool for use with adolescents and young adults aged 13-21 years. The Vanderbilt is a previously developed, freely available set of parent- and teacher-report questionnaires designed to identify ADHD and related disorders in children. The Vanderbilt measures have been chosen for inclusion in the new computerized Integrated Clinical Information Sharing System (ICISS) being rolled out in five Boston Children's Hospital (BCH) departments/divisions (Adolescent/Young Adult Practice, Children's Hospital Primary Care Center, Developmental Medicine Center, Department of Neurology, Department of Psychiatry). The Vanderbilt was developed and validated for use among children up to age 12 years (Wolraich et al., 2003; Wolraich et al., 2013; Bard et al., 2013), and little is known about its appropriateness for use among older youth. In addition, there is no self-report version of the Vanderbilt that can be administered directly to adolescents and young adults (ages 13-21 years), for whom parents and teachers are often less knowledgeable reporters. To address these shortcomings, a multidisciplinary team of BCH adolescent health clinicians and researchers modified the parent and teacher Vanderbilt questionnaires to make them age-appropriate for adolescents and young adults and created a complementary self-report version for adolescents and young adults. The goal of the current study is to 1) assess the feasibility and acceptability of online administration through the ICISS system of the new parent, teacher, and youth self-report Vanderbilt measures among adolescent and young adult BCH patients aged 13-21 years; 2) test their reliability in terms of internal consistency reliability, temporal stability of responses over a one-month test-retest, and inter-rater agreement across all informants (parents, teachers, and youths); and 3) test their validity by evaluating their convergence with a similar set of ADHD screening tools, the Conners scales, already validated for use with adolescents and young adults.


Condition
ADHD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Validation of the Vanderbilt Attention Deficit Hyperactive Disoder (ADHD) Measure for Adolescent Patients in the Integrated Clinical Information Sharing System (ICISS) Project

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Reliability of the Vanderbilt [ Time Frame: One month after initial administration of Vanderbilt ] [ Designated as safety issue: No ]
    We will assess for each measure the level of internal consistency reliability, temporal stability of responses over a one-month test-retest, and inter-rater agreement across all informants (parents, teachers, and youths).


Secondary Outcome Measures:
  • Validity of Vanderbilt [ Time Frame: One month after initial administration of Conners ] [ Designated as safety issue: No ]
    We will assess construct validity by evaluating the degree to which the Vanderbilt measures show convergence with a similar set of ADHD screening tools, the Conners scales, already validated for use with adolescents up to age 18 years (the Conners 3rd Edition Parent, Teacher, and youth Self-Report scales) and with young adults ages 19-21 years (the Conners Adult ADHD Rating Scale - Self-Report and Observer-Report versions).


Estimated Enrollment: 400
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
This is a psychometric study of a screening tool for ADHD, so we will not be administering any treatments or interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Boston Children's Hospital patients which will be recruited from the following divisions: Adolescent/Young Adult Practice, Developmental Medicine Center and Department of Psychiatry.

Criteria

Inclusion Criteria:

  • Patients ages 13-21 who already have an ADHD diagnosis or are being evaluated for ADHD.
  • Parent/guardian will be asked to participate for patients ages 13-21.
  • Teachers will be asked to participate for patients ages 13-21.
  • All informants should be able to read and understand English at a 5th grade reading level; and enrolled in the ICISS system.

Exclusion Criteria:

  • Cognitive impairment or developmental delay.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964209

Contacts
Contact: Griselda Potka, BA 617-355-6168 Griselda.Potka@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital, Adolescent/ Young Adult Clinic Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Griselda Potka, BA    617-355-6168    Griselda.Potka@childrens.harvard.edu   
Contact: Joshua Borus, MD,MPH    617-355-7181    Joshua.Borus@childrens.harvard.edu   
Principal Investigator: Joshua Borus, MD,MPH         
Sub-Investigator: Elizabeth R. Woods, MD,MPH         
Sub-Investigator: Sion K. Harris, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Joshua Borus, MD,MPH Children's Hospital Boston
  More Information

Publications:
Responsible Party: Joshua Borus, Fellow, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01964209     History of Changes
Other Study ID Numbers: 83064
Study First Received: October 10, 2013
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
ADHD
Validation
Quality Improvement
Vanderbilt
Conners 3rd Edition
ADHD Measures
ADHD Adolescent
ADHD Questionnaire
ICISS
Integrated Clinical Information Sharing System

ClinicalTrials.gov processed this record on September 18, 2014