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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital tool that integrates with the Collaborative Life Skills Program to assist students with ADHD in resource-limited schools. The goal is to enhance accessibility and effectiveness for students who often face attention and behavior challenges. The trial compares the usual school services with this new digital approach to determine if it improves support for these students. Students in grades 2-5, who experience attention and behavior challenges and qualify for free or reduced lunch, may be suitable candidates for this study. As a Phase 2 trial, this research measures the effectiveness of the digital tool in an initial, smaller group of students, providing an opportunity to participate in an innovative approach to ADHD support.

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 prior data suggests that the Collaborative Life Skills dHealth tool (CLS-D) is safe for students with ADHD?

Research has shown that the Collaborative Life Skills Program (CLS) is a trusted school-based program for students with ADHD. The program is now being updated to include a digital tool called CLS-D. Since schools already use the CLS program, it is considered very safe, with no reports of serious side effects in students.

The current study is in the early stages of testing the digital version, so researchers are still gathering information on how well students handle it. However, because the original program has been safely used in schools, the digital version is also expected to be safe. This ongoing research will help confirm that the digital version is as well-tolerated as the original. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Collaborative Life Skills dHealth tool (CLS-D) for treating ADHD because it offers a unique digital approach to skill-building for students, parents, and teachers. Unlike traditional treatments for ADHD, which often rely on medication like stimulants or behavior therapy conducted in person, CLS-D is a digitally adapted program that can be accessed from anywhere. This makes it more accessible and flexible for busy families and educators, potentially increasing engagement and consistency in the treatment process. Additionally, by directly involving students, parents, and teachers, this tool fosters a collaborative environment that might enhance the overall effectiveness of ADHD management.

What evidence suggests that the Collaborative Life Skills dHealth tool (CLS-D) is effective for ADHD?

Research has shown that the Collaborative Life Skills Program (CLS) helps reduce ADHD symptoms. Studies have found that both parents and teachers noticed improvements in ADHD and oppositional defiant disorder symptoms after using CLS. Known as a school-based behavioral intervention, this program will be tested in a trial where some participants receive the new digital version, CLS-D. This version aims to make the benefits more accessible, especially in schools with fewer resources. Early results suggest that digital health tools can help spread this effective program more widely. ^{1 2 3 4 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. psych.ucsf.edu psych.ucsf.edu/HALP/research/CLSD

Collaborative Life Skills Digital Mental Health Project (CLS- ... The Collaborative Life Skills Program's (CLS) effectiveness is well established. This four-year project aims to enhance the feasibility and usability of CLS ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06886217

Study Details | NCT06886217 | Extending the Reach of ... The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based ...

3. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-collaborative-life-skills-program

Efficacy of the Collaborative Life Skills Program | IES Student outcomes across the following four domains will be measured: (a) Attention-Deficit/Hyperactivity Disorder (ADHD) symptom severity as indicated by parent ...

4. withpower.com withpower.com/trial/phase-2-control-condition-8-2024-f4aef

Collaborative Life Skills Tool for ADHD (CLS-D Trial) The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890856718300546

Sustained Effects of Collaborative School-Home ... Within-group analyses indicated that parent- and teacher-reported post-treatment gains for CLS in ADHD and oppositional defiant disorder symptoms, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619661/

Randomized Controlled Trial of CLS-R-FUERTE - PMC Many of the participating students showed reliable change in ADHD/ODD symptom counts and the pre-post effect sizes for ADHD symptom and ...