Collaborative Life Skills Tool for ADHD

(CLS-D Trial)

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: San Diego State University

Disqualifiers: Visual impairment, Hearing impairment, Language delay, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

216 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Collaborative Life Skills dHealth tool (CLS-D) for ADHD?

Research shows that the Collaborative Life Skills (CLS) program, which is similar to CLS-D, helps improve ADHD symptoms and functioning in children by involving schools, parents, and students in a coordinated effort. Studies have documented beneficial effects of CLS on ADHD symptoms and related impairments, even after the program ends. ^{1 2 3 4 5}

Is the Collaborative Life Skills Tool for ADHD safe for humans?

The available research on the Collaborative Life Skills (CLS) program for ADHD does not specifically mention any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 5 6 7}

How is the Collaborative Life Skills Tool for ADHD different from other treatments?

The Collaborative Life Skills (CLS) program is unique because it integrates school, parent, and student treatments, delivered by school-based mental health providers, and includes booster sessions to maintain benefits over time. This approach focuses on collaboration between home and school environments, which is not typically emphasized in other ADHD treatments. ^{1 2 3 5 8}

What is the purpose of this trial?

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.

Research Team

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

Eligibility Criteria

This trial is for students in grades 2-5 with attention and behavior issues, enrolled in San Diego or San Francisco Bay area schools that offer free/reduced lunch. It includes their caregivers, school mental health professionals, and teachers. Excluded are those with severe language delays, psychosis, pervasive developmental disorders, global intellectual impairments, significant sensory impairments or other disabilities related to ADHD.

Inclusion Criteria

Students must be enrolled in the school districts in the San Diego or San Francisco Bay area

Students must be eligible for free or reduced lunch

Students must be identified by teachers, school mental health professionals, and/or parents with students who have inattention and behavioral problems

Exclusion Criteria

Students with severe language delay, psychosis

Students with pervasive developmental disorder

Students with global intellectual impairment

Timeline

Discovery and Design

Focus groups with SMHPs, teachers, students, and parents to inform CLS adaptations and dHealth tool development

4 weeks

Focus groups and design sessions

Test and Refine

Iterative usability testing and open trials to refine the CLS-D prototype

6 weeks

Weekly usability testing sessions

Evaluation

Pilot randomized trial to evaluate the feasibility and promise of CLS-D

10 weeks

Regular monitoring and data collection

Follow-up

Collection of follow-up data on student outcomes

End of the first quarter during the subsequent school year

Treatment Details

Interventions

• Collaborative Life Skills dHealth tool (CLS-D)

Trial Overview The study tests the Collaborative Life Skills dHealth tool (CLS-D), a digital adaptation of an established behavioral intervention for ADHD students. The goal is to make it feasible for resource-limited schools serving low-SES backgrounds to support these students effectively.

Participant Groups

Group I: Collaborative Life Skills Experimental Treatment 1 Intervention

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

Group II: Business As Usual Active Control 1 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.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

The Collaborative Life Skills (CLS) program, a 12-week psychosocial intervention for primary-school students with ADHD, showed significant improvements in ADHD symptoms and organizational functioning compared to usual school services, based on a study involving 135 students across 23 schools.

Students in the CLS program also demonstrated better academic performance and reduced symptoms of oppositional defiant disorder, indicating that this evidence-based approach can effectively enhance functional outcomes for children with ADHD in a school setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a School-Implemented School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. Pfiffner, LJ., Rooney, M., Haack, L., et al.[2019]

The Collaborative Life Skills (CLS) program, which integrates treatments for students with ADHD, showed significant improvements in parent-reported symptoms and functional impairment even after a maintenance period into the next school year, based on a study involving 135 students across 23 schools.

While parents reported sustained benefits in ADHD and oppositional defiant disorder symptoms, the lack of significant improvements in teacher-reported outcomes suggests a need for additional strategies to enhance effectiveness with new teachers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. Pfiffner, LJ., Rooney, ME., Jiang, Y., et al.[2019]

The Collaborative Life Skills (CLS) program provides a comprehensive intervention for children with ADHD, involving training for teachers, parents, and children over 10 to 12 weeks to improve academic and social outcomes.

Booster treatments in subsequent school years are essential for maintaining the benefits of the initial intervention, highlighting the need for ongoing support to prevent long-term negative impacts on education and social relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. DuPaul, GJ.[2019]

The Child Life and Attention Skills (CLAS) program significantly improved inattention, organizational skills, and social skills in children with ADHD-I compared to both parent-focused treatment and treatment as usual, based on a study involving 199 children aged 7-11.

Improvements from the CLAS program were maintained at follow-up for most parent-reported measures, highlighting the effectiveness of integrating treatment components across home and school settings for better outcomes in managing ADHD-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-site randomized clinical trial of integrated psychosocial treatment for ADHD-inattentive type. Pfiffner, LJ., Hinshaw, SP., Owens, E., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a School-Implemented School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Life Participation Scale for Attention-Deficit/Hyperactivity Disorder--Child Version: psychometric properties of an adaptive change instrument. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Development and validation of the ADHD Benefits of Coaching Scale (ABCS). [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A two-site randomized clinical trial of integrated psychosocial treatment for ADHD-inattentive type. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

The social play, social skills and parent-child relationships of children with ADHD 12 months following a RCT of a play-based intervention. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Quality of life of adolescent males with attention-deficit hyperactivity disorder. [2017]