- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018794
Development of a Mobile App for an Executive Functioning Intervention for Adolescents
November 19, 2021 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common childhood mental health disorders, affecting 7-9% of children and adolescents, and leading to substantial impairment in adolescence.
Despite evidence suggesting that behavioral interventions are efficacious, approximately 40-60% 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 (dHealth) strategies and gamification techniques, offer unique opportunities for overcoming the barriers of 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 primary goal of this study is to develop and preliminarily test the integration of a digital health tool into organizational/behavioral skills treatment for adolescents with ADHD by improving executive functioning skills, providing in-vivo skills reinforcement, and monitoring adolescents' skill utilization.
The proposed research will use an iterative stakeholder-centered design to develop, refine, and preliminarily test a novel digital health tool, applied as an adjunct to behavioral treatment for adolescents with ADHD (ages 11-15).
This includes focus groups with key stakeholders and an open preliminary feasibility trial and usability testing.
Data collected from focus groups will inform what content and features could be developed to overcome challenges to adolescent engagement and parent involvement.
During the open trial (N=20) we will assess intervention feasibility, usability, and acceptability.
During and after the clinical trial, we will collect continuous feedback from users on the usability and utility of the tool.
At the end of this study we will complete debugging and programming to maximize usability before a future larger clinical trial.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral/organizational skills intervention plus mobile app
Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks)
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Behavioral/organizational skills intervention with digital health application augmentation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Usability Scale
Time Frame: at month 3 (1-month post-intervention)
|
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).
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at month 3 (1-month post-intervention)
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Post Stakeholder Feasibility and Usability Rating
Time Frame: at month 3 (1-month post-intervention)
|
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).
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at month 3 (1-month post-intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Services Use in Children and Adolescents - Parent Interview (SCA-PI)
Time Frame: Change from Baseline (month 0) to Post-Intervention (3 months)
|
SCA-PI (Hoagwood et al., 2004) will assess medication and psychosocial treatment use and changes in use including any school (e.g., Daily Report Card) or community services during the study from baseline/pre-treatment (month 0) to post-intervention (3 months).
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Change from Baseline (month 0) to Post-Intervention (3 months)
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Demographics/Background Form
Time Frame: Baseline (month 0)
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A background form will collect information sufficient to calculate Hollingshead Socioeconomic Index as well as family income, marital status, and child's developmental and psychiatric history.
Teachers and SMHPs will also complete a brief demographic form to assess age, race, and experience.
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Baseline (month 0)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melissa R Dvorsky, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
November 23, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAS# A127552
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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