Control ConditionPhase 2CLS-DNCT06886217
Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
A Phase 2 study testing Collaborative Life Skills dHealth tool (CLS-D) in people with Control Condition and Intervention Condition, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Control Condition, Intervention Condition
- What is being tested?
- Collaborative Life Skills dHealth tool (CLS-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
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.
Read the 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.
- Conditions
- Control Condition, Intervention Condition
- Being tested
- Collaborative Life Skills dHealth tool (CLS-D)
- Keywords
- ADHD, school mental health, digital health interventions, implementation science, web-based applications
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Life Skills dHealth tool (CLS-D)Behavioural
Also called Collaborative Life Skills (CLS) program
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Life Skills dHealth tool (CLS-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Researchers will rate the school mental health professional's fidelity to the Collaborative Life Skills intervention based on the level of intervention content covered (coverage of each item is rated on a scaled from 0 to 2 where 0 = not covered, 1= partially covered, 2= mostly covered. The quality of intervention implementation regarding school mental health provider's use of clinical skills (e.g., reviewed homework, effectively reviewed handouts, used strategies to promote engagement, asked questions, followed time management guidelines) during each session is also rated on a 1 to 5 scale.
Measured: Weekly during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control ConditionStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Miguel Villodas, PhD, Principal investigator, Department of Psychology, College of Sciences, San Diego State UniversityLinda Pfiffner, PhD, Principal investigator, Department of Psychiatry, School of Medicine, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886217
- Sponsor's protocol ID
- HS-2024-0192
- Other IDs
- R324A240184
- Acronym
- CLS-D
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
- ClinicalTrials.gov ID
- NCT06886217
- Acronym / sponsor ID
- CLS-D / HS-2024-0192
- Conditions
- Control Condition, Intervention Condition
- Keywords
- ADHD, school mental health, digital health interventions, implementation science, web-based applications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Collaborative Life Skills dHealth tool (CLS-D)Student, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Life Skills dHealth tool (CLS-D)Also: Collaborative Life Skills (CLS) programThe 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. | Behavioural | Collaborative Life Skills |
Primary outcome
System Usability Scale
Time frame: During the 4th week of intervention and following the last week of the 8-week intervention
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).
The Feasibility Rating Scale
Time frame: During the 4th week of intervention and following the last week of the 8-week intervention
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.
1 secondary outcome
Collaborative Life Skills (CLS) intervention fidelity checklist for school mental health providers
Time frame: Weekly during intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Collaborative Life Skills Digital Mental Health Project (CLS-D)Link provided by the sponsor.
- IES funded research grant: Extending the Reach of Evidence-Based Practices to Support Student Attention and Behavior Through TechnologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Villodas, PhD principal investigator
Department of Psychology, College of Sciences, San Diego State University
Linda Pfiffner, PhD principal investigator
Department of Psychiatry, School of Medicine, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collaborative Life Skills dHealth tool (CLS-D) in people with Control Condition and Intervention Condition, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: During the 4th week of intervention and following the last week of the 8-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.