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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist children with ADHD in schools by enhancing an existing program with team-based strategies. The goal is to determine if adding strategies like improved team communication and coordination makes the program more effective at improving ADHD symptoms and daily functioning. Children who may be suitable for the trial have noticeable ADHD-related challenges and have been referred by a school mental health provider. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative educational strategies that could significantly improve ADHD management in school settings.

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 prior data suggests that this program is safe for children with ADHD?

Research has shown that the Collaborative Life Skills Program (CLS) is generally manageable for participants. Previous studies found that CLS combines activities at school and home without major safety issues. By enhancing communication and collaboration through methods like Team Charters and Communication Training, the Team-Enhanced CLS aims to amplify these benefits. Studies using these methods have reported no serious problems, suggesting that this approach is safe for schools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Team-Enhanced Collaborative Life Skills Program for ADHD because it offers a fresh approach by integrating team-based strategies to existing methods. Unlike traditional ADHD treatments, which often focus on medication or isolated behavioral interventions, this program emphasizes teamwork through Team Charters, improved communication via Student Handoff Protocols, and Team Performance Monitoring. These strategies aim to boost how well teams work together, improving trust and coordination, which could lead to better outcomes for kids with ADHD. This innovative approach could reshape how we support students with ADHD by enhancing the effectiveness of school-based interventions.

What evidence suggests that the Team-Enhanced Collaborative Life Skills Program is effective for ADHD?

Research has shown that the Collaborative Life Skills Program (CLS), a treatment arm in this trial, improves symptoms and daily functioning in children with ADHD. This program involves working with teachers, training parents, and teaching skills to children over 10-12 weeks. Studies have found that these components work together to reduce ADHD symptoms in kids.

The Team-Enhanced Collaborative Life Skills Program (CLS-T), another treatment arm in this trial, incorporates team-based methods like Team Charters and Communication Training. These methods enhance team communication and collaboration, potentially increasing the program's effectiveness. Early results suggest that these additions might lead to better outcomes for children with ADHD compared to the regular CLS. ^{1 2 3 5 6}

Who Is on the Research Team?

Miguel Villodas, Ph.D.

Principal Investigator

San Diego State University

Linda Pfiffner, Ph.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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 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 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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11091493

Enhancing team effectiveness for a collaborative school ... The specific aims are to 1) Evaluate the effectiveness of CLS-T implementation, relative to standard CLS, on implementation outcomes; 2) Evaluate the ...

2. 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 ...

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06180681

Enhancing Team Effectiveness for a Collaborative School ... The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ...

4. 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 ...

5. trialx.com trialx.com/clinical-trials/listings/268749/enhancing-team-effectiveness-for-a-collaborative-school-based-intervention-for-adhd/

Enhancing Team Effectiveness for a Collaborative School ... The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD ...

6. withpower.com withpower.com/trial/phase-team-effectiveness-research-2024-76cbf

Enhanced Collaborative Life Skills Program for ADHD 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 ...