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临床试验/NCT01964209
NCT01964209已完成不适用

Initial Validation of the Vanderbilt Attention Deficit Hyperactive Disoder (ADHD) Measure for Adolescent Patients in the Integrated Clinical Information Sharing System (ICISS) Project

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Reliability of the Vanderbilt

研究概览

简要总结

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.

详细描述

Background and Specific Aims:

Study Design: We will use the ICISS system's capacity for prospective and ongoing collection of data from enrolled patients and their families to conduct our prospective, longitudinal study consisting of a baseline assessment at enrollment into ICISS, a one-month re-test assessment, and a follow-up assessment at either 3 months for patients who were newly-diagnosed with ADHD or had a change in medication, or 6 months for patients with an established diagnosis and no medication changes.

Recruitment and Consent: Once a patient has enrolled in ICISS, they will be asked if they wish to participate in the modified Vanderbilt validation study, initially by phone call. Some patients and/or their parents will want to discuss this in person or may not be reached by phone call, in which case the research assistant will meet with them at the clinic visit. This will take place in a quiet, confidential space.

However, with adolescents it is typical that the parent is not present at the clinic visit. The Vanderbilt validation study will then be discussed with the parent verbally by phone and consent will be implicit in answering the two Conners questionnaires when sent online. Interested and eligible patients will be reminded in this email that participation in this research study is completely voluntary, that a decision not to participate will not affect their medical care in any way and that they may withdraw from the study at any time.

As participation in this study consists simply of answering two Conners questionnaires which represent the standard of care for ADHD both nationally and in our clinics, presents virtually no risk to the participant above the minimal risks associated with the general ICISS study, and the parent, participant and teacher all have the option to simply not respond to the email requesting Conners completion for this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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-
  • Teachers will be asked to participate for patients ages 13-
  • All informants should be able to read and understand English at a 5th grade reading level; and enrolled in the ICISS system.

排除标准

  • Cognitive impairment or developmental delay.

结局指标

主要结局

Reliability of the Vanderbilt

时间窗: One month after initial administration of Vanderbilt

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).

次要结局

  • Validity of Vanderbilt(One month after initial administration of Conners)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Borus

Staff Physician

Boston Children's Hospital

研究点 (1)

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