Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology

NCT06886217 | Enrolling By Invitation Phase 2

• 2 other identifiers: HS-2024-0192R324A240184
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Control Condition; Intervention Condition

Keywords

ADHD; school mental health; digital health interventions; implementation science; web-based applications

Outcome Measures

Primary Outcomes (2)

• System Usability Scale

  This is a psychometrically validated questionnaire will be administered to school mental health professionals, teachers, and parents to assess how easy and user-friendly an interface or digital tool is for its users. This is a 10-item technology agnostic scale assessing technology product usability, with scores above 80 indicating good usability (Brooke, 2014; Lewis \& Sauro, 2009, 2018). The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8).

  During the 4th week of intervention and following the last week of the 8-week intervention

• The Feasibility Rating Scale

  This will be completed by principals, teachers, and school mental health professionals. This measure will contain items regarding the amount of time required to participate in the program, the level of effort needed to identify and enroll students in the program, the availability of physical space needed to run in-person groups, etc. We will query SMHPs weekly (real time) about CLS-D demands on their time, with specific questions regarding their use of the dHealth tool.

  During the 4th week of intervention and following the last week of the 8-week intervention

Secondary Outcomes (1)

• Collaborative Life Skills (CLS) intervention fidelity checklist for school mental health providers

  Weekly during intervention

Other Outcomes (2)

• Student Academics

  Baseline; Post-intervention; Follow-up at the end of the first quarter during the subsequent school year

• Student Behavioral Progress

  Weekly during intervention

Study Arms (2)

Business As Usual

NO INTERVENTION

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.

Collaborative Life Skills

EXPERIMENTAL

Student, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program.

Behavioral: Collaborative Life Skills dHealth tool (CLS-D)

Interventions

Collaborative Life Skills dHealth tool (CLS-D) BEHAVIORAL

The purpose of this adapted intervention 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-researchers 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.

Also known as: Collaborative Life Skills (CLS) program

Collaborative Life Skills

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Links

• Collaborative Life Skills Digital Mental Health Project (CLS-D)
• IES funded research grant: Extending the Reach of Evidence-Based Practices to Support Student Attention and Behavior Through Technology

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Miguel Villodas, PhD

  Department of Psychology, College of Sciences, San Diego State University

  PRINCIPAL INVESTIGATOR

• Linda Pfiffner, PhD

  Department of Psychiatry, School of Medicine, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)