Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Throu… (NCT06886217) | Clinical Trial Compass
By InvitationPhase 2
Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
United States216 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
System Usability Scale
Timeframe: During the 4th week of intervention and following the last week of the 8-week intervention
2
The Feasibility Rating Scale
Timeframe: During the 4th week of intervention and following the last week of the 8-week intervention