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

NCT06900673 | Enrolling By Invitation Early Phase 1 DMC

• 2 other identifiers: HS-2024-0193U54MD012397
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Control Condition; Intervention Condition

Keywords

ADHD; digital health technology; school mental health; health equity; child mental health

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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.

  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

  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

  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 (7)

• Intervention Fidelity

  Completed in-vivo during during weekly parent and student group during the 8-week intervention

• Parent Strategy Use Questionnaire

  Completed each week during the 8-week intervention directly following the parent group intervention

• Daily Behavioral Report Card Completion

  Completed throughout each day during the 8-week intervention period

Study Arms (2)

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.

Behavioral: Collaborative Life Skills

Interventions

Collaborative Life Skills BEHAVIORAL

Student, parents, and teachers in the intervention condition will receive the digitally adapted Collaborative Life Skills program.

Collaborative Life Skills

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Francisco: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

San Diego State University HealthLINK Center for Transdisciplinary Health Disparities Research

San Diego, California, 92182, United States

Location

Related Links

• NIH Reporter: Reducing Disparities in Access to Evidence-based Services for ADHD Through Technology

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Miguel Villodas, PhD

  Department of Psychology, College of Sciences, San Diego State University

  PRINCIPAL INVESTIGATOR

• Linda Pfiffner, PhD

  Department of Psychiatry, School of Medicine, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 28, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)