Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ADD
  • ADHD
  • ADHD - Combined Type
  • ADHD Predominantly Inattentive Type
  • ADHD, Predominantly Hyperactive - Impulsive
  • Attention Deficit Disorder
  • "Attention Deficit Hyperactivity Disorder"
  • Attention-Deficit Disorder in Adolescence
  • Attention Deficit Hyperactivity Disorder Symptoms
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A preliminary feasibility effectiveness trial comparing two groups: (1) organizational/behavioral skills intervention augmented with digital health application and (2) organizational/behavioral skills intervention onlyMasking: Single (Outcomes Assessor)Masking Description: The outcomes assessor will be masked to invention condition when collecting baseline and post-intervention measures with the participants.Primary Purpose: Treatment

Participation Requirements

Age
Between 11 years and 15 years
Gender
Both males and females

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 behavi...

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.

Tracking Information

NCT #
NCT04729439
Collaborators
Not Provided
Investigators
Not Provided