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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT04018794
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder Symptoms	Device: Behavioral/organizational skills intervention augmented with digital health application	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: One group with behavioral/organizational skills intervention augmented with digital health applicationOne group with behavioral/organizational skills intervention augmented with digital health application
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of a Mobile App for an Executive Functioning Intervention for Adolescents
• Actual Study Start Date: Sep 30, 2019
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. System Usability Scale [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).

2. Post Stakeholder Feasibility and Usability Rating [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).

Other Outcome Measures

1. Services Use in Children and Adolescents - Parent Interview (SCA-PI) [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).

2. Demographics/Background Form [Baseline (month 0)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Youth ages of 11-14 years (6-8th grade) that are attending a participating school
• 1. referred by SMHP as a youth with apparent ADHD-related problems,
• 1. ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
• 1. ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
• 1. 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.
• 1. 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.
• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Melissa R Dvorsky, PhD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 9, 2020

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04018794
• Other Study ID Numbers: RAS# A127552
• First Posted: Jul 15, 2019
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Recruitment Details	All participants were recruited from local schools and enrolled were assigned to a single-arm/group where they all evaluated the usability and feasibility of the ATOM intervention tool as designed. Ratings of usability and feasibility were collected before and after using the ATOM tool.
Pre-assignment Detail	All participants were assigned to a single-arm/group where they all evaluated the usability and feasibility of the ATOM intervention tool as designed. None were excluded upon enrollment.

Arm/Group Title	Behavioral/Organizational Skills Intervention Plus Mobile App
Arm/Group Description	Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks) Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Behavioral/Organizational Skills Intervention Plus Mobile App
Arm/Group Description	Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks) Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
Overall Participants	15
Age (Count of Participants)
<=18 years	15 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	7 46.7%
Male	8 53.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 13.3%
Not Hispanic or Latino	13 86.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 26.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 40%
White	4 26.7%
More than one race	1 6.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	System Usability Scale
Description	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).
Time Frame	at month 3 (1-month post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral/Organizational Skills Intervention Plus Mobile App
Arm/Group Description	Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks) Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
Measure Participants	15
Mean (Full Range) [score on a scale]	71

2. Primary Outcome

Title	Post Stakeholder Feasibility and Usability Rating
Description	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).
Time Frame	at month 3 (1-month post-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral/Organizational Skills Intervention Plus Mobile App
Arm/Group Description	Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks) Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
Measure Participants	15
Mean (Full Range) [units on a scale]	4.3

3. Other Pre-specified Outcome

Title	Services Use in Children and Adolescents - Parent Interview (SCA-PI)
Description	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).
Time Frame	Change from Baseline (month 0) to Post-Intervention (3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Demographics/Background Form
Description	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.
Time Frame	Baseline (month 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Adverse events were assessed at the time of data collection for each participant and monitored by the study coordinator and study staff.
Arm/Group Title	Behavioral/Organizational Skills Intervention Plus Mobile App
Arm/Group Description	Behavioral/organizational skills intervention plus mobile application (16, 20-30 minute sessions, twice/weekly for 8 weeks) Behavioral/organizational skills intervention augmented with digital health application: Behavioral/organizational skills intervention with digital health application augmentation
All Cause Mortality
	Behavioral/Organizational Skills Intervention Plus Mobile App
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Behavioral/Organizational Skills Intervention Plus Mobile App
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral/Organizational Skills Intervention Plus Mobile App
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.