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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • ADD
  • ADHD
  • ADHD - Combined Type
  • ADHD Predominantly Inattentive Type
  • ADHD, Predominantly Hyperactive - Impulsive
  • Attention Deficit Disorder
  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Attention-Deficit Disorder in Adolescence
  • Attention-Deficit Hyperactivity Disorder
  • Attention-Deficit Hyperactivity Disorder Symptoms
  • Disease
  • Hyperkinesis

NCT number NCT04729439
Study type Interventional
Source Children's National Research Institute
Contact Melissa R Dvorsky, Ph.D.
Phone 202-476-5000
Email ATOM@childrensnational.org
Status Recruiting
Phase Phase 1
Start date February 3, 2021
Completion date November 14, 2024

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