Collaborative Life Skills for ADHD

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: San Diego State University

Disqualifiers: Visual, hearing, language, psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new version of the Collaborative Life Skills Program (CLS) enhanced with mobile health technology (mHealth) to assist 2nd to 5th graders with ADHD in schools. The goal is to make the program more user-friendly and accessible, especially in schools with fewer resources. The trial will determine if this digital version can improve communication and support among teachers, parents, and school mental health providers to better manage ADHD in children. It may suit children in 2nd to 5th grade who qualify for free or reduced lunch and spend most of their school day in a regular classroom. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on behavioral interventions for children with ADHD, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that the Collaborative Life Skills program is safe for children with ADHD?

Research has shown that the Collaborative Life Skills (CLS) program is generally safe for children with ADHD. Studies on CLS report no specific safety concerns, indicating it is well-tolerated. This program involves collaboration among school staff, teachers, and parents to improve children's behavior and social skills. By focusing on creating a supportive environment rather than introducing new medications, it often presents fewer safety issues compared to drug treatments. Overall, CLS aims to help children manage ADHD symptoms through behavioral and social skills training without known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Collaborative Life Skills program for ADHD because it offers a fresh approach by integrating digital tools into traditional support systems. Unlike standard treatments for ADHD, which often rely on medication like stimulants and behavioral therapy, this program involves a digitally adapted method that actively engages students, parents, and teachers. This collaboration aims to improve not just the child's behavior but also the support network around them, potentially leading to more sustainable and holistic improvements in managing ADHD symptoms.

What evidence suggests that the Collaborative Life Skills program could be effective for children with ADHD?

Research has shown that the Collaborative Life Skills (CLS) program, which participants in this trial may receive, helps children with ADHD improve behavior and school performance. Studies have found that CLS leads to better teacher ratings of children's academic skills. The program also offers lasting benefits, with parents observing fewer ADHD symptoms and oppositional behaviors in their children into the next school year. CLS combines efforts from both school and home, involving teachers and parents to support children's social and organizational skills. This teamwork approach addresses the challenges children with ADHD face, making CLS a promising option for managing this condition. ^{1 4 6 7 8}

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 children in 2nd-5th grade with ADHD. It's designed to help schools with limited resources, particularly those serving low-socioeconomic status and ethnic/racial minority backgrounds. The goal is to make evidence-based ADHD services more accessible.

Inclusion Criteria

Participants in study must 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

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, or global intellectual impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline assessments are conducted to establish initial conditions and metrics

1 week

Intervention

Participants receive the digitally adapted Collaborative Life Skills program for 8 weeks

8 weeks

Weekly intervention groups

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 months after the subsequent school year starts

What Are the Treatments Tested in This Trial?

Interventions

• Collaborative Life Skills

Trial Overview The trial tests an adapted Collaborative Life Skills Program (CLS) supported by mHealth technology, aiming to coordinate efforts among school mental health providers, teachers, and parents. A web-based app will be developed for communication and tracking child progress.

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+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

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]

A study involving 45 adults with ADHD showed that ADHD coaching positively impacted various areas of concern, indicating its potential efficacy as a supportive intervention.

The research found significant test-retest reliability for the factors analyzed, suggesting that the benefits of ADHD coaching are consistent over time, although further studies are needed to fully understand its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ADHD coaching for adults with ADHD. Kubik, JA.[2015]

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 Program (CLS) significantly improved social and behavioral functioning in 57 children with attention and behavior problems, as reported by parents, teachers, and through report cards.

The effectiveness of the CLS intervention was enhanced when parents consistently applied the strategies, highlighting the importance of coordinating efforts between home and school for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additive effects of parent adherence on social and behavioral outcomes of a collaborative school-home behavioral intervention for ADHD. Villodas, MT., McBurnett, K., Kaiser, N., et al.[2021]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

Citations

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

Efficacy of the Collaborative Life Skills Program | IES ... this study is to conduct a randomized efficacy trial to evaluate the effects of CLS on behavioral and academic outcomes for students with symptoms of ADHD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4091627/

Educational Outcomes of a Collaborative School–Home ... CLS was associated with improvements in ADHD and multiple measures of important educational outcomes, including teacher ratings of academic skills, parent ...

3. 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 ...

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

Sustained Effects of Collaborative School-Home ... These results extend support for CLS to the following school year by demonstrating sustained benefits on parent-reported ADHD and oppositional defiant disorder ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01686724

Study of the Collaborative Life Skills Program | ... This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity ...

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

Collaborative Life Skills Tool for ADHD (CLS-D Trial) The available research on the Collaborative Life Skills (CLS) program for ADHD does not specifically mention any safety concerns, suggesting it is generally ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6587063/

Social skills training for attention deficit hyperactivity disorder ... We examined the benefits and harms of social skills training on social skills, emotional competencies, general behaviour, ADHD symptoms, performance in school ...

8. psych.ucsf.edu psych.ucsf.edu/HALP/research/CLS

Collaborative Life Skills Program (CLS) CLS combines three existing behavioral treatments: behavioral parent training, a daily report card with teacher consultation, and child skills training.