Technology-Enhanced Executive Functioning Intervention for ADHD

NCT04729439 | Unknown Phase 1 FDA Device

• 1 other identifier: PRO#00014877
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study develops and refines an online platform that will support clinician-directed behavioral and organizational skills intervention for adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) with input guided from key stakeholders during focus groups and interviews (phase 1), extended usability testing (phase 2), and a pilot randomized trial (phase 3) of the online tool used in conjunction with an organizational skills intervention.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; ADD; ADHD Predominantly Inattentive Type; ADHD - Combined Type; ADHD, Predominantly Hyperactive - Impulsive; Attention-Deficit Disorder in Adolescence; Attention-Deficit Hyperactivity Disorder Symptoms; Attention-Deficit Hyperactivity Disorder

Keywords

ADHD; Attention-Deficit/Hyperactivity Disorder; Executive Functioning

Outcome Measures

Primary Outcomes (5)

• Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version

  The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha \>.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Teacher Version

  The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha \>.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• Impairment Rating Scale (IRS) Parent Version

  The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels parent-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• Impairment Rating Scale (IRS) Teacher Version

  The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels teacher-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• System Usability Scale

  10-item technology agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess change system usability at the end of software development (month 6), during the intervention trial (month 10), at post-treatment (month 12), and at 6-months post-intervention follow-up (month 18).

  Month 6, Month 10, Month 12, Month 18

Secondary Outcomes (3)

• Barkley Deficits in Executive Functioning Scale (BDEFS-CA)

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

• Revised Child Anxiety and Depression Scales (RCADS)

  Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

Study Arms (2)

Organizational/behavioral intervention + digital health tool

EXPERIMENTAL

Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills \[HOPS\]) plus the online digital health application during treatment

Behavioral: Homework Organization and Planning Skills (HOPS) Intervention; Device: Digital Health Application (Online Platform) for Encouraging Skills Practice

Organizational/behavioral intervention only

ACTIVE COMPARATOR

Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills \[HOPS\]) only, without the online digital health application during treatment

Behavioral: Homework Organization and Planning Skills (HOPS) Intervention

Interventions

Homework Organization and Planning Skills (HOPS) Intervention BEHAVIORAL

A behavioral/organizational skills intervention focused on improving adolescents' homework, organization, and planning skills

Organizational/behavioral intervention + digital health tool; Organizational/behavioral intervention only

Digital Health Application (Online Platform) for Encouraging Skills Practice DEVICE

This online platform can be used on participants' personal devices including laptops, phones, tablets, or other computers and is designed to encourage adolescent's skills practice, monitor and reward treatment progress, and optimize motivation in treatment

Also known as: Advanced Tools for Organization Management

Organizational/behavioral intervention + digital health tool

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Youth ages of 11 to 14 that are attending a participating school
• referred by school mental health provider as a youth with apparent ADHD-related problems
• ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
• ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
• Parent consent and youth assent must be provided

You may not qualify if:

• No presence of conditions that are incompatible with this study's treatment including: Parent or adolescent report of a prior diagnosis of either Autism Spectrum Disorder, Bipolar Disorder, a Dissociative Disorder, Severe visual or hearing impairment, severe language delay or intellectual impairment, or a Psychotic Disorder will be excluded. Rationale: Individuals with these disorders often have very dysregulated behavior and impairments that deviate from the focus of this study.
• Adolescent is in all-day special education classes or if core classes not in regular education classrooms. Rationale: The vast majority of adolescent with ADHD are served in regular education classrooms and students in full-day self-contained classrooms often have different challenges than students in regular education.
• Adolescent planning to change (start or stop) psychotropic medication. Note: Adolescents taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Adolescent taking medication for attention or behavior are eligible as long as their medication regimens are stable. Participating parents will also need to be able to read/speak English because all measures are in English, and the intervention will be conducted in English.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Research Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

ALPL protein, human; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Melissa R Dvorsky, Ph.D.

CONTACT

202-476-5000; ATOM@childrensnational.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Model Details: A preliminary feasibility effectiveness trial comparing two groups: (1) organizational/behavioral skills intervention augmented with digital health application and (2) organizational/behavioral skills intervention only

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: February 3, 2021
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)