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Behavioural Intervention
Enhanced Collaborative Life Skills Program for ADHD
N/A
Recruiting
Led By Linda Pfiffner, 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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am between 7 and 11 years old and attend a participating school.
Select...
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), 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), follow-up (6 months after the end of intervention).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability, Feasibility, and Appropriateness of Intervention Measure
DBRC Completion
Intervention Fidelity
+3 moreSecondary study objectives
Academic Competency Evaluation Scale
Child and Adolescent Symptom Inventory-5
Children's Organizational Skills Scales
+3 moreOther study objectives
Card-Sorting Task
Cohesion scale of Teamwork Quality
Collaboration & Satisfaction About Care Decisions (CSACD)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,903 Total Patients Enrolled
1 Trials studying Implementation Science
190 Patients Enrolled for Implementation Science
University of California, San FranciscoOTHER
2,587 Previous Clinical Trials
14,901,032 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,028 Total Patients Enrolled
4 Trials studying Implementation Science
783 Patients Enrolled for Implementation Science
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