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Clinical Trial Summary

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.


Clinical Trial Description

The specific aims are: Aim 1. Evaluate the effectiveness of CLS-T implementation, relative to standard CLS, on implementation outcomes. It is hypothesized that parent-teacher-SMHP implementation teams (N = 72) in schools randomized to CLS-T (N = 12) will have a significantly greater proportion of completed daily behavioral report cards, use more intervention strategies, and have greater fidelity and adherence to the intervention protocol than implementation teams (N = 72) in schools randomized to standard CLS (N = 12). The investigators will conduct focus groups with parents and teachers (Ns = 48), and SMHPs and school principals (Ns = 24) at schools assigned to each condition following the effectiveness trial and during the next school year to assess their perceptions and sustained use of the CLS-T and standard CLS implementation and intervention strategies. Aim 2. Evaluate the effectiveness of CLS-T implementation, relative to standard CLS implementation, on child outcomes. It is hypothesized that children in schools randomized to CLS-T implementation will demonstrate significantly greater improvements in their ADHD symptoms, academic, social, and behavioral functioning following the intervention, relative to children in standard CLS implementation schools. Aim 3. Use mixed-methods to examine if key team-based mechanisms are engaged by CLS-T implementation, relative to standard CLS implementation, and mediate its effects on implementation outcomes and child outcomes. It is hypothesized that implementation teams assigned to CLS-T implementation will have significantly stronger team-based emergent cognitive (e.g., shared mental models, situation awareness) and affective (e.g., trust, collective efficacy) states and team-based processes (e.g., communication, coordination) than implementation teams assigned to standard CLS implementation. The investigators will test whether these team-based mechanisms mediate the effects of CLS-T on implementation outcomes and child outcomes. The investigators will analyze qualitative data from focus groups to identify themes related to team-based mechanisms. The investigators will identify and leverage team communication data sources that are feasible, naturally occurring, and appropriate for school settings (e.g., CLS team meetings, CLS website communication) to submit to the Methods Core for the development of Natural Language Processing (NLP) tools. ;


Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/ Hyperactivity Disorder
  • Implementation Science

NCT number NCT06180681
Study type Interventional
Source University of California, San Diego
Contact Lilliana Conradi, BA
Phone 16196513154
Email lconradi@health.ucsd.edu
Status Recruiting
Phase N/A
Start date January 1, 2024
Completion date May 31, 2027

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