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

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ClinicalTrials.gov Identifier: NCT04018794
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: One 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
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  2. Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Teacher Version [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater teacher-rated ADHD symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  3. Impairment Rating Scale (IRS) Parent Version [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels parent-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  4. Impairment Rating Scale (IRS) Teacher Version [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels teacher-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  5. System Usability Scale [ Time Frame: Month 6, Month 10, Month 12 ]
    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 change system usability at the end of software development (month 6), during the intervention trial (month 10), and at post-treatment (month 12).


Secondary Outcome Measures :
  1. Behavior Rating Inventory of Executive Function (BRIEF 2) Parent Version [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The BRIEF is a 86-item measures of executive functioning abilities (Gioia et al., 2000) and generates two index scores: the behavioral regulation index and the metacognition index (MI), and eight clinical scales: Shift, Inhibit, Emotion Control, Initiate, Working Memory, Organization of Materials, Plan/Organize, and Monitor scales. Higher scale scores on the BRIEF represent greater severity of executive functioning difficulties. The present study will examine change in executive functioning from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  2. Revised Child Anxiety and Depression Scales (RCADS) [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The RCADS (Chorpita et al., 2005) is a 47-item measure (in the public domain) that assesses adolescent-report of DSM-based anxiety and depression symptoms. The RCADS has been validated for use with students in 3rd through 12th grade. The RCADS has excellent reliability and validity in clinical and school-based samples (Ebesutani et al., 2010). Items are rated from 0 (Never) to 3 (Always), with higher scores indicating higher levels of anxiety and depressive symptoms. The present study will examine change in anxiety and depressive symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).

  3. Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    The BIS/BAS Scales (Carver & White, 1994; Pagliaccio et al., 2016) is a 24-item (includes 4 filler items) self-report measure of reinforcement/reward sensitivity rated on a four-point scale to assess theoretical concepts of BIS and BAS function and their roles in motivation, behavior, and affect. Specifically, items on BAS assess pursuit of appetitive goals, reward responsivity, tendencies to seek new, potentially rewarding experiences, and tendencies to act quickly towards goals. Items assessing BIS sensitivity focus more narrowly on concerns about possible negative/punishing events and sensitivity to the occurrence of such events. Higher scores on the BIS and BASC scales indicate greater sensitivity to rewards and punishments. The present study will examine change in reward and reinforcement sensitivity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later).


Other Outcome Measures:
  1. Services Use in Children and Adolescents - Parent Interview (SCA-PI) [ Time Frame: Change from Baseline (month 0) to Post-Intervention (up to 12 weeks later) ]
    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 (up to 12 weeks later).

  2. Demographics/Background Form [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018794


Contacts
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Contact: Melissa R Dvorsky, Ph.D. 415-476-7167 melissa.dvorsky@ucsf.edu

Locations
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United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Melissa R Dvorsky    415-476-7167    melissa.dvorsky@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Melissa R Dvorsky, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04018794     History of Changes
Other Study ID Numbers: RAS# A127552
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders