Development of a Mobile App for an Executive Functioning Intervention for Adolescents

NCT04018794 | Completed Results FDA Device

• 1 other identifier: RAS# A127552
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Outcome Measures

Primary Outcomes (2)

• System Usability Scale

  10-item technology-agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess system usability at post-treatment (month 3).

  at month 3 (1-month post-intervention)

• Post Stakeholder Feasibility and Usability Rating

  8-item Stakeholder Feasibility and Usability Rating (SFUR) was used to assess stakeholders' perceptions of the overall feasibility and usability of the program. The SFUR score is a mean of all items and ranges from 1 to 5, with higher scores indicating higher feasibility and usability. This measure was developed for the present study. The present study will assess these feasibility ratings at post-treatment (month 3).

  at month 3 (1-month post-intervention)

Other Outcomes (2)

• Services Use in Children and Adolescents - Parent Interview (SCA-PI)

  Change from Baseline (month 0) to Post-Intervention (3 months)

• Demographics/Background Form

  Baseline (month 0)

Study Arms (1)

Behavioral/organizational skills intervention plus mobile app

EXPERIMENTAL

Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)

Device: Behavioral/organizational skills intervention augmented with digital health application

Interventions

Behavioral/organizational skills intervention augmented with digital health application DEVICE

Behavioral/organizational skills intervention with digital health application augmentation

Behavioral/organizational skills intervention plus mobile app

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) Youth ages of 11-14 years (6-8th grade) that are attending a participating school
• \) referred by SMHP 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 adolescent assent must be provided; b)

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Results Point of Contact

• Title: Dr. Melissa Dvorsky
• Organization: University of California, San Francisco

melissa.dvorsky@ucsf.edu

4154767167

Study Officials

• Melissa R Dvorsky, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group with behavioral/organizational skills intervention augmented with digital health application

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: September 30, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-11

Locations

US (1)