Clinical trial NCT06900673: Reducing Disparities in Access to Evidence-Based Services for Attention Deficit Hyperactivity Disorder (ADHD) Through Technology
Official title: Reducing Disparities in Access to Evidence-Based Services for ADHD Through Technology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Control Condition
Intervention Condition
Keywords: ADHD
digital health technology
school mental health
health equity
child mental health
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-28
Enrollment: 350
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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.

Primary outcomes:
measure: Child and Adolescent Symptom Inventory-5
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
measure: Children's Organizational Skills Scales
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
measure: Impairment Rating Scale
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
measure: Homework Problems Checklist
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
measure: Academic Competency Evaluation Scale
timeFrame: 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:
measure: Alabama Parenting Questionnaire
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
measure: Parent-Teacher Involvement Questionnaire
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Other outcomes:
measure: Intervention Fidelity
timeFrame: Completed in-vivo during during weekly parent and student group during the 8-week intervention
measure: Parent Strategy Use Questionnaire
timeFrame: Completed each week during the 8-week intervention directly following the parent group intervention
measure: Daily Behavioral Report Card Completion
timeFrame: Completed throughout each day during the 8-week intervention period
measure: Feasibility Rating Scale
timeFrame: Completed each week during the 8-week intervention directly following weekly intervention groups
measure: Intervention Satisfaction
timeFrame: Completed each week during the 8-week intervention directly following weekly intervention groups
measure: System Usability Scale
timeFrame: Following usability testing; the week after the end of the 8-week intervention
measure: Services for Children and Adolescents Parent Interview
timeFrame: Screening, Baseline, the week after the end of the 8-week intervention, and follow-up approximately 2 months after the subsequent school year starts.
Locations:
city: San Diego
country: United States
facility: San Diego State University HealthLINK Center for Transdisciplinary Health Disparities Research
state: California
Study officials:
affiliation: Department of Psychology, College of Sciences, San Diego State University
name: Miguel Villodas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, School of Medicine, University of California San Francisco
name: Linda Pfiffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: