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

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the Collaborative Life Skills program safe for humans?

The available research on the Collaborative Life Skills program for ADHD does not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

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

The Collaborative Life Skills (CLS) treatment is unique because it integrates school, parent, and student interventions, delivered by school-based mental health providers, to address ADHD symptoms. It includes a 12-week program with booster sessions in the following school year, focusing on improving social skills, independent task completion, and collaboration between teachers and parents, which is not typically emphasized in other treatments. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Collaborative Life Skills for ADHD?

Research shows that the Collaborative Life Skills (CLS) program, which involves school, parent, and student treatments, helps improve social and behavioral functioning in children with ADHD. Studies found that children showed significant improvements in their behavior and social skills when the program was implemented, and these benefits were even greater when parents actively participated in the intervention. ^{1 2 3 6 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, 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 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 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]

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

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

2. 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]

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

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

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

Additive effects of parent adherence on social and behavioral outcomes of a collaborative school-home behavioral intervention for ADHD. [2021]

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

Efficacy of ADHD coaching for adults with ADHD. [2015]

6. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

8. 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]