Control ConditionEarly Phase 1NCT06900673
Reducing Disparities in Access to Evidence-Based Services for Attention Deficit Hyperactivity Disorder (ADHD) Through Technology
A Early Phase 1 study testing Collaborative Life Skills in people with Control Condition and Intervention Condition, run by San Diego State University at 1 site in United States.
Trial summary
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and… 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Mar 2029
- Phase
- Early Phase 1
- 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
- Participants in study must be be teachers, parents of children with ADHD, and school mental health providers.
- Students will be identified by school staff and administrators, with whom the investigators have existing relationships.
- Caregivers/parents will be included if their students are:
- Enrolled full-time in a participating elementary schools.
- In a mainstream classroom for the majority of the school day
- In 2nd- 5th grade
- Are eligible for free or reduced lunch
- Parents must also live with the identified child.
Who cannot join
- Parents are excluded from the study if their children have:
- Significant visual impairment
- Significant hearing impairment
- Severe language delay
- Psychosis
- Pervasive developmental disorder
- Global intellectual impairment.
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 HealthLINK Center for Transdisciplinary Health Disparities Research
San Diego, California, 92182
About this study
Official title: Reducing Disparities in Access to Evidence-Based Services for ADHD Through Technology
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
Read the detailed description
The proposed pilot project aims to extend the reach of evidence-based behavioral intervention services for children from low-SES and ERM families by developing the first school-based after-school intervention model for elementary school children with ADHD and enhancing it with mobile health (mHealth) technology. In partnership with an urban elementary school, the investigators will recruit panels of key opinion leaders representing five stakeholder groups, including teachers, school mental health professionals, after-school staff, parents, and children with ADHD to participate in a series of three focus groups that aim to:
Aim 1: Assess the existing resources, organizational capacity, and unmet needs of low-SES and ERM children with ADHD at the school. Focus groups will be conducted with each stakeholder panel to identify the service capacity and unmet needs of children with ADHD. A logic model of the problem will be developed to inform the identification of existing evidence-based interventions and mHealth solutions that could fit the context.
Aim 2: Adapt existing interventions and design mock mHealth application prototypes. Intervention models and mHealth solutions will be presented to stakeholder panels in a second set of focus groups to solicit feedback about the perceived need for adaptations to the interventions and fit of the mHealth solutions with the needs, environment, conditions, capacity, and culture of the target school/population. Adaptations will be made the to intervention and mock mHealth examples based on stakeholder feedback will produce an intervention model prototypes.
Aim 3: Evaluate the perceived usability, acceptability and feasibility of the intervention model and mock mHealth prototypes. A third set of focus groups with stakeholder panels will assess their perceptions of the intervention model and mock mHealth prototypes. Usability testing of the mHealth prototypes will be conducted with three members of each panel to identify design issues, assess task completion, and solicit user feedback.
Impact: The findings of the present project will lay the foundation for a subsequent proposal for funding (e.g., R21, R34) to further develop the intervention materials and mHealth applications and evaluate their feasibility and initial impact in a pilot implementation trial.
- Conditions
- Control Condition, Intervention Condition
- Being tested
- Collaborative Life Skills
- Keywords
- ADHD, digital health technology, school mental health, health equity, child mental health
- 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 SkillsBehavioural
Student, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Adolescent Symptom Inventory-5
Parents and teachers will complete the Child and Adolescent Symptom Inventory-5 , which includes 78 items assessing DSM-5 symptoms of ADHD, ODD, CD, Mood, and Anxiety. It has demonstrated adequate reliability (rs = .66-.78) and internal consistency (αs = .90-.94).
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Children's Organizational Skills Scales
Parents and teachers will complete the Children's Organizational Skills Scales (COSS), which includes subscales assessing organizational skills, management of materials/supplies, and task planning skills (parent = 58 items, teacher = 35 items), with items rated on a 4-point scale. The parent and teacher versions both have excellent internal consistency (αs = .98 and .97, respectively), test-retest reliability (rs = .99 and .94, respectively), and evidence of structural, convergent, and discriminant validity.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Impairment Rating Scale
Parents and teachers will report about students' functioning (e.g., academic, behavioral, peer, etc.) on the Impairment Rating Scale using a 6-point scale (0 = "needs no treatment" to 6 = "definitely requires treatment") with a rating greater than 2 suggests significant impairment requiring intervention.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Homework Problems Checklist
Parents will complete the Homework Problems Checklist which consists of 20 items rated on a 4-point scale and has evidence of excellent internal consistency (α = .90-.92) to assess child problems related to homework.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Academic Competency Evaluation Scale
Teachers will complete the Academic Enablers scale of the Academic Competency Evaluation Scale, which measures behaviors that support adaptive learning in the classroom. This subscale demonstrates excellent psychometric properties, including high test-retest reliability (r = .96) and internal consistency (α = .98) for children in grades 3-5.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Secondary outcomes (2)
Alabama Parenting Questionnaire
Parents will complete the Alabama Parenting Questionnaire (APQ), which consists of 42 parent-reported items and five subscales: involvement, positive parenting, monitoring, inconsistent discipline, and corporal punishment. The subscales have been validated using confirmatory factor analysis and have demonstrated evidence of reliability and validity.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parent-Teacher Involvement Questionnaire
Parents and teachers will complete the Parent-Teacher Involvement Questionnaire (PTIQ) which consists of 47 items and six subscales: parent-teacher contact, parent involvement at school, quality of parent-teacher relationship, teacher's perception of the parent, parent involvement at home, and parent endorsement of school. The subscales have been validated using confirmatory factor analysis and have demonstrated evidence of reliability and validity.
Measured: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Sep 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute on Minority Health and Health Disparities (NIMHD)
- 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
- NCT06900673
- Sponsor's protocol ID
- HS-2024-0193
- Other IDs
- U54MD012397
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Access to Evidence-Based Services for ADHD Through Technology
- ClinicalTrials.gov ID
- NCT06900673
- Acronym / sponsor ID
- HS-2024-0193
- Conditions
- Control Condition, Intervention Condition
- Keywords
- ADHD, digital health technology, school mental health, health equity, child mental health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 28 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.
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
Detailed description
The proposed pilot project aims to extend the reach of evidence-based behavioral intervention services for children from low-SES and ERM families by developing the first school-based after-school intervention model for elementary school children with ADHD and enhancing it with mobile health (mHealth) technology. In partnership with an urban elementary school, the investigators will recruit panels of key opinion leaders representing five stakeholder groups, including teachers, school mental health professionals, after-school staff, parents, and children with ADHD to participate in a series of three focus groups that aim to:
Aim 1: Assess the existing resources, organizational capacity, and unmet needs of low-SES and ERM children with ADHD at the school. Focus groups will be conducted with each stakeholder panel to identify the service capacity and unmet needs of children with ADHD. A logic model of the problem will be developed to inform the identification of existing evidence-based interventions and mHealth solutions that could fit the context.
Aim 2: Adapt existing interventions and design mock mHealth application prototypes. Intervention models and mHealth solutions will be presented to stakeholder panels in a second set of focus groups to solicit feedback about the perceived need for adaptations to the interventions and fit of the mHealth solutions with the needs, environment, conditions, capacity, and culture of the target school/population. Adaptations will be made the to intervention and mock mHealth examples based on stakeholder feedback will produce an intervention model prototypes.
Aim 3: Evaluate the perceived usability, acceptability and feasibility of the intervention model and mock mHealth prototypes. A third set of focus groups with stakeholder panels will assess their perceptions of the intervention model and mock mHealth prototypes. Usability testing of the mHealth prototypes will be conducted with three members of each panel to identify design issues, assess task completion, and solicit user feedback.
Impact: The findings of the present project will lay the foundation for a subsequent proposal for funding (e.g., R21, R34) to further develop the intervention materials and mHealth applications and evaluate their feasibility and initial impact in a pilot implementation trial.
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 SkillsStudent, 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 (8 listed)
- Participants in study must be be teachers, parents of children with ADHD, and school mental health providers.
- Students will be identified by school staff and administrators, with whom the investigators have existing relationships.
- Caregivers/parents will be included if their students are:
- Parents must also live with the identified child.
Key exclusion criteria (7 listed)
- Parents are excluded from the study if their children have:
- Significant visual impairment
- Significant hearing impairment
- Severe language delay
- Psychosis
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 SkillsStudent, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program. | Behavioural | Collaborative Life Skills |
Primary outcome
Child and Adolescent Symptom Inventory-5
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parents and teachers will complete the Child and Adolescent Symptom Inventory-5 , which includes 78 items assessing DSM-5 symptoms of ADHD, ODD, CD, Mood, and Anxiety. It has demonstrated adequate reliability (rs = .66-.78) and internal consistency (αs = .90-.94).
Children's Organizational Skills Scales
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parents and teachers will complete the Children's Organizational Skills Scales (COSS), which includes subscales assessing organizational skills, management of materials/supplies, and task planning skills (parent = 58 items, teacher = 35 items), with items rated on a 4-point scale. The parent and teacher versions both have excellent internal consistency (αs = .98 and .97, respectively), test-retest reliability (rs = .99 and .94, respectively), and evidence of structural, convergent, and discriminant validity.
Impairment Rating Scale
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parents and teachers will report about students' functioning (e.g., academic, behavioral, peer, etc.) on the Impairment Rating Scale using a 6-point scale (0 = "needs no treatment" to 6 = "definitely requires treatment") with a rating greater than 2 suggests significant impairment requiring intervention.
Homework Problems Checklist
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parents will complete the Homework Problems Checklist which consists of 20 items rated on a 4-point scale and has evidence of excellent internal consistency (α = .90-.92) to assess child problems related to homework.
Academic Competency Evaluation Scale
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Teachers will complete the Academic Enablers scale of the Academic Competency Evaluation Scale, which measures behaviors that support adaptive learning in the classroom. This subscale demonstrates excellent psychometric properties, including high test-retest reliability (r = .96) and internal consistency (α = .98) for children in grades 3-5.
2 secondary outcomes
Alabama Parenting Questionnaire
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Parent-Teacher Involvement Questionnaire
Time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
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 13 Apr 2026.
- NIH Reporter: Reducing Disparities in Access to Evidence-based Services for ADHD 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 Early Phase 1 study testing Collaborative Life Skills 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 8 inclusion and 7 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 13 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Child and Adolescent Symptom Inventory-5 (time frame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.). The study lists 5 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 13 Apr 2026.