Reducing Disparities in Access to Evidence-Based Services for Attention Deficit Hyperactivity Disorder (ADHD) Through Technology
NCT06900673 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2026-04-13
Summary
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
Conditions
- Control Condition
- Intervention Condition
Interventions
- BEHAVIORAL
-
Collaborative Life Skills
Student, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program.
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
San Diego State University
lead OTHER
Principal Investigators
-
Miguel Villodas, PhD · Department of Psychology, College of Sciences, San Diego State University
-
Linda Pfiffner, PhD · Department of Psychiatry, School of Medicine, University of California San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2029-03-31
- Completion
- 2029-03-31
Countries
- United States
Study Locations
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