Clinical trial NCT06886217: Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
Official title: Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Control Condition
Intervention Condition
Keywords: ADHD
school mental health
digital health interventions
implementation science
web-based applications
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2025-03-20
Enrollment: 216
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.

Detailed description: Setting: The research will take place in urban elementary schools in California that receive Title 1 funds to support students who qualify for free or reduced lunch.

Sample: Participants will be SMHPs (one per school) who work half or full time in a school with limited resources that serve students from predominantly low-SES backgrounds, students in grades 2-5 who have ADHD-related impairments (referred to as with or at risk for ADHD), and their parents. In the discovery and design phase, 8 SMHPs, 12 teachers, 12 students, and 12 parents will participate. In the test and refine phase, 4 SMHPs, 24 students, and their parents and teachers, will participate. In the evaluation phase, 12 SMHPs and 72 students and their parents and teachers will participate.

Intervention: The CLS-D intervention, which will be designed to maximize usability, feasibility, and acceptability in schools with limited resources, will include CLS's three evidence-based behavioral treatments for ADHD: behavioral parent training, daily report card with teacher consultation, and child skills training. CLS-D's dHealth tool will consist of a web-based portal with user interfaces for SMHPs, teachers, parents, and students that will be designed to mitigate traditional barriers to accessing services among students with ADHD from low-SES backgrounds. CLS-D will be implemented over a 10-week period and be compatible with various operating systems and devices, including smart phones, tablets, and computers.

Research Design and Methods: During the discovery and design phase, researchers will conduct focus groups with panels of SMHPs, teachers, and students with or at risk for ADHD from low-SES backgrounds and their parents to inform CLS adaptations and dHealth tool development. Researchers and consultants will design an initial prototype of the dHealth tool and adapt CLS-D training, fidelity monitoring, and cost evaluation protocols. During the test and refine phase, researchers will refine the prototype through iterative usability testing with stakeholder panels. Researchers will conduct open trials with SMHPs, students with or at risk for ADHD, and their parents and teachers to test the usability, feasibility, and acceptability of CLS-D, training, fidelity monitoring, and cost evaluation tools. Researchers will also conduct focus groups with participants following the open trials and make final refinements to CLS-D protocols. During the evaluation phase, researchers will use a pilot randomized trial, assigning SMHPs/schools to the CLS-D or control condition, to evaluate the feasibility and promise of CLS-D and the associated costs. The pilot will include two staggered cohorts (fall, spring) in which researchers match pairs of schools based on the proportion of students eligible for free or reduced lunch, the number of students, and racial/ethnic composition. In fall of the school year after the pilot randomized trial, researchers will collect follow-up data on student outcomes.

Control Condition: Students in the control condition will receive the usual services their schools provide to students with or at risk for ADHD in grades 2-5.

Key Measures: Key measures during the discovery and design phase will include a psychometrically validated System Usability Scale (SUS) that SMHPs, teachers, and parents will complete, and a researcher-designed satisfaction scale for SMHPs. During the test and refine phase, key measures will include the SUS, CLS-D usage analytics, and researcher-designed pre/post acceptability and feasibility scales that parents, students, teachers, and SMHPs will complete. During the evaluation and follow-up phase, key measures will include the SUS, acceptability, and feasibility scales; a researcher-developed SMHP fidelity checklist; student-level school records of grades, discipline, and services received; and standardized achievement test scores.

Data Analytic Strategy: For the discovery and design phase, researchers will conduct rapid qualitative content analyses of focus group data using the Rigorous and Accelerated Data Reduction (RADaR) technique and analyze quantitative ratings from the focus groups using descriptive statistics. In the test and refine phase, researchers will use the RADaR technique to analyze qualitative data; use descriptive statistics to analyze process measures, cost measures, and usage analytics; and calculate within-subjects mean differences and Cohen's d effect sizes for pre- and post-assessment data. For the evaluation phase and follow up, researchers will conduct an intent-to-treat analysis using hierarchical linear modeling to examine between-group differences in student outcomes.

Cost Analysis: Researchers will conduct a cost analysis based on a societal perspective using the ingredients approach. Researchers will include information from the cost evaluation tools they will develop during the project, and they will calculate total costs, average cost per student served, the range of costs per student served, and marginal costs per student added once CLS-D is established.

Eligibility criteria: Student eligibility criteria:

* Identified by teachers, school mental health professionals, and/or parents with students who have inattention and behavioral problems.
* Must be enrolled in the school districts in the San Diego or San Francisco Bay area
* Must be in 2nd-5th grade
* Placed in a mainstream class
* Eligibility for free or reduced lunch
* Living with a caregiver who is available to participate in treatment
* Must NOT have:

  * Significant visual or hearing impairment
  * Severe language delay, psychosis
  * Pervasive developmental disorder
  * Global intellectual impairment.

Adult participants groups eligibility criteria:

* Parents or caregivers of eligible students can participate in the study.
* School mental health professionals who work with the eligible students can participate in the study.
* Teachers who work with the eligible students can participate in the study.

Exclusion Criteria:

* Researchers will include children with symptoms and impairment of ADHD.
* Researchers would like to involve children in mainstream class placement rather than those who already have services from school (e.g., special education classes).
* Researchers will target those from low SES backgrounds who are eligible for reduced or free lunch.
* All students are expected to be physically healthy, but it should be noted that students with ADHD often have high rates of co-morbid disabilities.
* Furthermore, the researchers would like to invite parents/caregivers, school mental health professionals, and teachers who work with students with ADHD to be involved in focus groups

Primary outcomes:
measure: System Usability Scale
timeFrame: During the 4th week of intervention and following the last week of the 8-week intervention
measure: The Feasibility Rating Scale
timeFrame: During the 4th week of intervention and following the last week of the 8-week intervention
Secondary outcomes:
measure: Collaborative Life Skills (CLS) intervention fidelity checklist for school mental health providers
timeFrame: Weekly during intervention
Other outcomes:
measure: Student Academics
timeFrame: Baseline; Post-intervention; Follow-up at the end of the first quarter during the subsequent school year
measure: Student Behavioral Progress
timeFrame: Weekly during intervention
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: Department of Psychology, College of Sciences, San Diego State University
name: Miguel Villodas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, School of Medicine, University of California San Francisco
name: Linda Pfiffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: