Reducing Disparities in Access to Evidence-Based Services for Attention Deficit Hyperactivity Disorder (ADHD) Through Technology

Early Phase 1

• Conditions: Control Condition; Intervention Condition

• Registration Number: NCT06900673
• Lead Sponsor: San Diego State University

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.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child and Adolescent Symptom Inventory-5	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).
Impairment Rating Scale	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	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	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.
Children's Organizational Skills Scales	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.

Secondary Outcome Measures

Name	Time	Method
Alabama Parenting Questionnaire	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 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.
Parent-Teacher Involvement Questionnaire	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 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.

Trial Locations

Locations (1)

San Diego State University HealthLINK Center for Transdisciplinary Health Disparities Research; 🇺🇸 San Diego, California, United States