Clinical trial NCT04729439: Technology-Enhanced Executive Functioning Intervention for ADHD
Official title: Development of a Technology-Enhanced Executive Functioning Skills Intervention for Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
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
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 only
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Youth ages of 11 to 14 that are attending a participating school
2. referred by school mental health provider as a youth with apparent ADHD-related problems
3. ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
4. ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
5. Parent consent and youth assent must be provided

Exclusion Criteria:

1. 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.
2. 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.
3. 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.

Primary outcomes:
measure: Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Teacher Version
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: Impairment Rating Scale (IRS) Parent Version
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: Impairment Rating Scale (IRS) Teacher Version
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: System Usability Scale
timeFrame: Month 6, Month 10, Month 12, Month 18
Secondary outcomes:
measure: Barkley Deficits in Executive Functioning Scale (BDEFS-CA)
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
measure: Revised Child Anxiety and Depression Scales (RCADS)
timeFrame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Research Institute
state: District of Columbia
Study officials:
References: