N/A
N=15
Development of a Mobile App for an Executive Functioning Intervention for Adolescents
Attention Deficit Hyperactivity Disorder Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT04018794 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: System Usability Scale — 71 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral/organizational skills intervention augmented with digital health application (Device)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY System Usability Scale |
71 | — |
| PRIMARY Post Stakeholder Feasibility and Usability Rating |
4.3 | — |
Summary
This study develops an initial prototype of a mobile tool that will support clinician-directed behavioral/organizational skills treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) with input guided from key stakeholders.
Eligibility Criteria
Inclusion Criteria
- 1) Youth ages of 11-14 years (6-8th grade) that are attending a participating school
- 2) referred by SMHP 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 adolescent assent must be provided; b)
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.
Data sourced from ClinicalTrials.gov (NCT04018794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.