NCT04729439

Technology-Enhanced Executive Functioning Intervention for ADHD

Development of a Technology-Enhanced Executive Functioning Skills Intervention for Adolescents With ADHD

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 11 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common childhood mental health disorders, affecting 7-9% of youth and leading to substantial impairment in adolescence. Despite evidence suggesting that behavioral interventions are efficacious, 41-60% of adolescents receiving behavioral treatment show little to no improvement and skills are rarely generalized beyond treatment sessions. Lack of adolescent motivation and engagement, between-session skills use, reward saliency, and family involvement are key contributors to these limited effects. Mobile digital health strategies and gamification techniques offer transformative opportunities for overcoming the barriers of evidence-based treatments specific to ADHD by using interactive tools to reinforce in-vivo skill practice, providing opportunities for immediate reinforcement, and motivating adolescents with digital rewards. The goal of this proposal is to develop and evaluate an online platform tool that will support clinician-directed behavioral treatment for adolescents with ADHD by improving executive functioning skills acquisition and utilization, providing in-vivo skills reinforcement, and monitoring adolescents' skill utilization. This study will use an empirically supported intervention specifically designed to address the domains of impairment frequently experienced by adolescents with ADHD. This study will use an iterative stakeholder-centered design to develop, refine, and preliminarily test a scalable digital health tool, applied as an adjunct to behavioral treatment for adolescents with ADHD. This includes focus groups with key stakeholders (Define), extended formative usage evaluation (Refine), and an open preliminary feasibility trial and usability testing (Pilot). Our goal is to develop and preliminary test an online platform that increases engagement, skills generalization, and family involvement in an empirically-supported organization skills intervention for adolescents with ADHD.

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

Interventions

Type	Name	Description
BEHAVIORAL	Homework Organization and Planning Skills (HOPS) Intervention	A behavioral/organizational skills intervention focused on improving adolescents' homework, organization, and planning skills
DEVICE	Digital Health Application (Online Platform) for Encouraging Skills Practice	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

Timeline

• Start date: 2021-02-03
• Primary completion: 2024-11-14
• Completion: 2024-11-14
• First posted: 2021-01-28
• Last updated: 2023-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study