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Behavioural Intervention

Team-Enhanced Collaborative Life Skills Program Implementation for Implementation Science

N/A

Recruiting

Led By Miguel Villodas, Ph.D.

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth ages of 7-11 years (2-5th grade) who are attending a participating school

≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

Awards & highlights

Study Summary

This trial aims to improve the effectiveness of a program called the Collaborative Life Skills Program (CLS) for children with ADHD. The researchers will use different strategies to enhance the implementation of the program, such

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves educational and organizational interventions rather than medical treatments, traditional side effects are not applicable. However, there may be challenges such as increased workload or changes in team dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been reported to show significant inattention or hyperactivity-impulsivity symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability, Feasibility, and Appropriateness of Intervention Measure

DBRC Completion

Intervention Fidelity

+3 more

Secondary outcome measures

Academic Competency Evaluation Scale

Child and Adolescent Symptom Inventory-5

Children's Organizational Skills Scales

+3 more

Other outcome measures

Card-Sorting Task

Cohesion scale of Teamwork Quality

Collaboration & Satisfaction About Care Decisions (CSACD)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Team-Enhanced Collaborative Life Skills Program ImplementationExperimental Treatment1 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 ImplementationActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,900 Total Patients Enrolled

1 Trials studying Implementation Science

190 Patients Enrolled for Implementation Science

University of California, San FranciscoOTHER

2,507 Previous Clinical Trials

15,238,431 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,555 Total Patients Enrolled

4 Trials studying Implementation Science

783 Patients Enrolled for Implementation Science

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, as stated on clinicaltrials.gov, this ongoing trial is currently seeking eligible candidates. The study was initially posted for recruitment on January 1st, 2024 and its most recent update occurred on December 12th, 2023."

Answered by AI

What is the upper limit for patient enrollment in this medical study?

"Indeed, as per the details provided on clinicaltrials.gov, this trial is presently in the recruitment phase. The initial posting of the clinical trial occurred on January 1st, 2024 and it was last updated on December 12th, 2023. A total of 144 participants are being sought from a single site for this study."

Answered by AI

Is the age limit for participants in this study restricted to individuals below 80 years of age?

"To participate in this clinical trial, individuals must be between 7 and 11 years old."

Answered by AI

Which individuals are eligible to participate in this research investigation?

"In order to meet the eligibility requirements for this trial, potential participants must possess knowledge in implementation science and fall between the ages of 7 and 11. This study aims to enroll approximately 144 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD

Lauren Brookman-Frazee 2024. "Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06180681.

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