Clinical Study Data Request Registered Users, Please Login


Proposal 1326

Title of the Proposed Research

Reliability and Validity of the Parent Rating of Evening and Morning Behavior Scale, Revised

Lead Researcher

Steven V. Faraone, Ph.D.

Affiliation

SUNY Upstate Medical University

Funding Source

The proposed analyses and publications can be completed without additional funding.

Potential Conflicts of Interest

In the past year, Dr. Faraone received income, potential income, travel expenses and/or research support from Arbor, Pfizer, Ironshore, Shire, Akili Interactive Labs, CogCubed, Alcobra, VAYA Pharma, Neurovance, Impax, NeuroLifeSciences. With his institution, he has US patent US20130217707 A1 for the use of sodium-hydrogen exchange inhibitors in the treatment of ADHD. In previous years, he received income or research support from: Shire, Alcobra, Otsuka, McNeil, Janssen, Novartis, Pfizer and Eli Lilly. Dr. Faraone receives royalties from books published by Guilford Press: Straight Talk about Your Child’s Mental Health, Oxford University Press: Schizophrenia: The Facts and Elsevier: ADHD: Non-Pharmacologic Interventions

Data Sharing Agreement Date

3 Nov 2015

Lay Summary

ADHD is a common disorder among children affecting 4 million children aged 3-17 years. ADHD leads to much impairment at home, at school and in other settings. Relatively little is known about ADHD symptoms in children during the early morning, how such symptoms affect the child and family, and how they respond to treatment. The child’s early morning behavior routine, especially on school days, deserves attention for several reasons. Between waking and arriving at school children must adhere to a series of complex behaviors (e.g., waking, dressing, eating, and self-hygiene/brushing teeth). Completing these behaviors requires time management and working memory skills, which are frequently impaired by ADHD symptoms [1]. One way to improve the outcomes of ADHD youth would be to reduce their symptoms and improve their functioning at home before they go to school. Given the impact of early morning ADHD-associated behaviors on patients and families, more work is needed to assess the reliability and validity of measures for use in clinical and treatment studies.

This project proposes to test the accuracy (reliability and validity) of the early morning behavior scale from a measure called the Daily Parent Rating of Evening and Morning Behavior (DPREMB). This project will use existing data on children with ADHD from another study reported by Michelson [2]. Although Michelson’s study had been designed to assess the effects of ADHD treatment, it includes data which can be used to assess the accuracy of the DPREMB, which have never been published. Findings of the proposed study will be posted within a year of its completion on a website, clinicaltrials.gov, and will be submitted to a journal for publication.

References
1.Whalen, C.K., et al., Toward mapping daily challenges of living with ADHD: maternal and child perspectives using electronic diaries. J Abnorm Child Psychol, 2006. 34(1): p. 115-30.
2.Michelson, D., et al., Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized placebo-controlled study. Am J Psychiatry, 2002. 159: p. 1896-1901.

Study Data Provided

Study LILLY-B4Z-MC-LYAT: Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride versus Placebo in Children with Attention-Deficit/Hyperactivity Disorder

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.