Recruiting
Phase 1

ADHD Intervention

Sponsor:

Children's National Research Institute

Code:

NCT04729439

Conditions

ADHD

Attention Deficit Hyperactivity Disorder

Attention Deficit Disorder

ADD

ADHD Predominantly Inattentive Type

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

Interventions

Homework Organization and Planning Skills (HOPS) Intervention

Digital Health Application (Online Platform) for Encouraging Skills Practice

Study Details

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

Study ID

NCT04729439

Start date

Feb 3, 2021

Status verified date

Feb, 2023

Completion date

Nov 14, 2024

Anticipated

Primary completion date

Nov 14, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Organizational/behavioral intervention + digital health tool

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

active comparator: Organizational/behavioral intervention only

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

Interventions

Homework Organization and Planning Skills (HOPS) Intervention

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

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

Primary outcome measure

  • Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention ]
  • System Usability Scale [ Time Frame: Month 6, Month 10, Month 12, Month 18 ]

Central Contacts and Locations

Central contacts

Locations

Children's National Research Institute

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Principal Investigator:

Melissa R Dvorsky, Ph.D.

More Information

Sponsor

Children's National Research Institute

Last update posted

Feb 21, 2023

Last verified

Feb, 2023

Keywords

  • ADHD
  • Attention-Deficit/Hyperactivity Disorder
  • Executive Functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2023-02-21.