A Naturalistic Study of Functional Impairment for Individuals With ADHD in the Early Morning and Late Afternoon/Evening Hours

NCT04473755 | Completed

• 1 other identifier: 800012103
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the burden and impact of ADHD impairment in the early morning and late afternoon/evening hours for adolescents and young adults. Functional impairments will focus on the currently identified areas of functional impairment in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, 2013) - namely, social, academic, and occupational functioning. This is necessary for two reasons: (1) the current literature on ADHD impairment and functioning is concentrated within elementary school children; and (2) studies of intervention effectiveness are typically concentrated during the school day. This current state of the literature ignores the obvious - as ADHD is a chronic disorder, it needs to be addressed as children grow into adolescence and young adulthood, and it needs to be remediated at times outside of the school day such as in the morning and late afternoon/evening. Therefore, the specific areas assessed in the present study will relate to driving, school, work, and family functioning. These are important areas to study, as the research literature has typically focused on elementary school and school-day behavior in assessments of symptom presentation, impairment, and treatment outcome. As individuals with ADHD grow older, the entire day becomes relevant in determinations of functioning (e.g., workdays may begin in the very early morning or last into the evening/night), and productivity can be assessed across waking hours rather than just across the elementary school day. Once areas of functional impairment in these times of day are determined, for this age group, treatment candidates can aim to address these treatment targets.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; impairment; symptoms

Outcome Measures

Primary Outcomes (4)

• Social Impairment

  Ecological, momentary assessment of social interaction impairment

  14 days

• ADHD symptoms

  Ecological, momentary assessment of ADHD symptoms

  14 days

• Driving behavior

  Sum of risky driving events (e.g., texting while driving; hard braking or acceleration

  14 days

• Percent of Behavioral Goals Met

  Percent of daily schedule goals met on time

  14 days

Study Arms (2)

ADHD

This group will include participants who meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.

Non-ADHD

This group will include participants who do not meet DSM-5 diagnostic criteria for ADHD and meet all other study inclusion criteria.

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be between 16-30 years of age and have an identified collateral rater (e.g., parent, partner). Half of the participants will have ADHD and the other half will not meet diagnostic criteria for ADHD. To reduce variability between the ADHD and non-ADHD groups, we will match participants on age (+/- 2 years), sex, and whether they are employed or unemployed.

You may qualify if:

• All participants will have an estimated IQ greater than 70, a valid driving license/permit, and no evidence of psychosis or autism spectrum disorder at level 2 or 3. Individuals will be classified in the ADHD group if they meet DSM-5 criteria for ADHD based on the evaluation. Individuals who do not meet criteria for ADHD will be placed in the non-ADHD group.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Center for Children and Families

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gregory A Fabiano

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: August 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)