What this study is
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.
What's being tested
- Collaborative Life Skills dHealth tool (CLS-D)
Intervention · 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.
Study details
- Sponsor
- San Diego State University
- Conditions
- Control Condition · Intervention Condition
- Enrolling
- 216 people
- Starts
- 2024-09-01
- Est. completion
- 2028-10-31
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSan Diego State University
San Diego, California, United States
Study team
Sponsor
San Diego State University
Study ID HS-2024-0192
Principal investigator
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
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.