Enhanced Collaborative Life Skills Program for ADHD

Overseen By Lilliana Conradi, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Psychotropic

Disqualifiers: Severe impairment, Special education, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD, the Collaborative Life Skills Program (CLS), to enhance its implementation and optimize its effectiveness. The investigators will tailor three empirically-supported team development interventions, Team Charters, Team Communication Training (Student Handoff Protocols), and Team Performance Monitoring, and integrate them into a team-enhanced CLS implementation protocol (CLS-T). Team Charters are a written document developed collaboratively by the team at the outset of their work together outlining expectations, goals, roles and responsibilities, and relevant policies and procedures for team collaborative operations. Research shows that Team Charters strengthen affective emergent states, such as trust and cohesion among team members, as well as cognitive emergent states, such as shared mental models. They also strengthen team processes, such as goal specification, communication, and coordination to optimize team effectiveness. Handoff protocols are widely used interventions for ensuring continuity in patient care and minimizing errors in medical settings. They have also been found to improve affective (e.g., trust, cohesion) and cognitive (e.g., shared mental models, situation awareness) emergent states among team members, enhancing team communication and coordination. Finally, Team Performance Monitoring provides feedback to teams that can motivate performance, provide opportunities for adaptation in the event of challenges, and prompt communication among team members. The investigators will conduct a Hybrid Type III cluster randomized trial in 24 schools in two large urban school districts, to evaluate whether CLS-T implementation results in improved implementation outcomes and child outcomes in comparison to standard CLS implementation.

Do I need to stop my current medications to join the trial?

You can continue taking your current medications as long as your medication regimen is stable and you meet all the entry criteria, including impairment criteria.

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

Research shows that the Collaborative Life Skills (CLS) program, which is part of the Enhanced Collaborative Life Skills Program, helps improve social and behavioral functioning in children with ADHD. The program involves working together with schools and families, and studies have found that children show significant improvements in their behavior and social skills when parents and teachers use the strategies regularly. ^{1 2 3 4 5}

Is the Enhanced Collaborative Life Skills Program for ADHD safe for humans?

The Collaborative Life Skills (CLS) program, which is similar to the Enhanced Collaborative Life Skills Program, has been used in schools for children with ADHD and involves teachers, parents, and students working together. There is no mention of safety concerns in the studies, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

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

The Enhanced Collaborative Life Skills 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 coordinating strategies across home and school to improve social and behavioral functioning, which is different from standard treatments that may not involve such comprehensive collaboration. ^{1 2 3 4 5}

Research Team

Linda Pfiffner, Ph.D.

Principal Investigator

University of California, San Francisco

Miguel Villodas, Ph.D.

Principal Investigator

San Diego State University

Eligibility Criteria

This trial is for schools with teams willing to implement a program to help children with ADHD. The teams will use strategies like Team Charters, Communication Training, and Performance Monitoring to improve the effectiveness of the Collaborative Life Skills Program.

Inclusion Criteria

Caretaker and teacher consent to participate in treatment and child provides assent.

≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)

I am between 7 and 11 years old and attend a participating school.

Exclusion Criteria

My child may start or stop taking medication for mental health.

My child is in a full-time special education program.

I or my child can read and speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the Collaborative Life Skills Program (CLS) and Team-Enhanced CLS (CLS-T) over a 10-12 week period

10-12 weeks

Weekly sessions

Post-Intervention Assessment

Evaluation of intervention outcomes and team-based mechanisms immediately following the intervention

Immediately following intervention

Follow-up

Participants are monitored for sustained use of EBP strategies and child outcomes 6 months after the end of intervention

6 months

Treatment Details

Interventions

• Team-Enhanced Collaborative Life Skills Program

Trial Overview The study compares two methods: the standard Collaborative Life Skills Program versus an enhanced version with team-based strategies (CLS-T). It's a cluster randomized trial in urban schools to see if CLS-T leads to better implementation and child outcomes.

Participant Groups

Group I: Team-Enhanced Collaborative Life Skills Program Implementation Experimental Treatment 1 Intervention

We will integrate three team-based implementation strategies to enhance team effectiveness in CLS, including Team Charters, Team Communication Training via Student Handoff Protocols, and Team Performance Monitoring. These interventions have been shown to improve cognitive (e.g., shared mental models) and affective ((e.g., trust, collective efficacy) team-based emergent states and enhance team-based processes, such as communication and coordination.

Group II: Standard Collaborative Life Skills Program Implementation Active Control 1 Intervention

CLS is a school-delivered intervention coordinating three empirically-supported approaches: teacher consultation and a daily behavior report card, behavioral parent training and child skills training. The three components are integrated over a 10-12 week period to improve symptoms and functional impairment among youth with ADHD.

Team-Enhanced Collaborative Life Skills Program is already approved in United States for the following indications:

Approved in United States as Collaborative Life Skills Program (CLS) for:

• Attention Deficit/Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

Findings from Research

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 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]

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]

References

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

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

5. 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]