UnknownPhase 1

Technology-Enhanced Executive Functioning Intervention for ADHD

United States60 participantsStarted 2021-02-03

Plain-language 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.

Who can participate

Age range11 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. 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.
✕. 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.

What they're measuring

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

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

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

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

System Usability Scale

Timeframe: Month 6, Month 10, Month 12, Month 18

Trial details

NCT IDNCT04729439

SponsorChildren's National Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-14

Contact for this trial

Melissa R Dvorsky, Ph.D.

202-476-5000 ATOM@childrensnational.org

View on ClinicalTrials.gov More ADHD trials

Plain-language summary

Who can participate

Age range11 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. 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.
✕. 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.

What they're measuring

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

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

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

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

System Usability Scale

Timeframe: Month 6, Month 10, Month 12, Month 18