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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral/organizational skills intervention augmented with digital health application | Device | Behavioral/organizational skills intervention with digital health application augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Services Use in Children and Adolescents - Parent Interview (SCA-PI) | 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). | Change from Baseline (month 0) to Post-Intervention (3 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa R Dvorsky, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral/Organizational Skills Intervention Plus Mobile App | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral/Organizational Skills Intervention Plus Mobile App | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Full Range | score on a scale | at month 3 (1-month post-intervention) |
|
3 months
Adverse events were assessed at the time of data collection for each participant and monitored by the study coordinator and study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral/Organizational Skills Intervention Plus Mobile App | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Dvorsky | University of California, San Francisco | 4154767167 | melissa.dvorsky@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 9, 2020 | Sep 25, 2021 | Prot_SAP_ICF_000.pdf |
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One group with behavioral/organizational skills intervention augmented with digital health application
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| Demographics/Background Form | 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. | Baseline (month 0) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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). | Posted | Mean | Full Range | units on a scale | at month 3 (1-month post-intervention) |
|
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| Other Pre-specified | Services Use in Children and Adolescents - Parent Interview (SCA-PI) | 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). | Not Posted | Change from Baseline (month 0) to Post-Intervention (3 months) | Participants |
| Other Pre-specified | Demographics/Background Form | 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. | Not Posted | Baseline (month 0) | Participants |
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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