NCT06180681 Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD
| NCT ID | NCT06180681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Team-effectiveness Research |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2024-01-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Youth ages of 7-11 years (2-5th grade) who are attending a participating school 2. Child referred by a school mental health provider (SMHP) with apparent ADHD-related problems, 3. ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory 4. ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment) 5. Caretaker and teacher consent to participate in treatment and child provides assent. Exclusion Criteria: 1. 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 2. Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings) 3. Parent/primary caregiver or child does not read or speak English. Note: Participats will need to be able to read/speak English because all measures are in English, and the intervention will be conducted in English. Parents will be given the option of having a research staff member assist them in completing the assessment measures. 4. Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.
Contact & Investigator
Miguel Villodas, Ph.D.
PRINCIPAL INVESTIGATOR
San Diego State University
Frequently Asked Questions
Who can join the NCT06180681 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 11 Years, studying Team-effectiveness Research. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06180681 currently recruiting?
Yes, NCT06180681 is actively recruiting participants. Contact the research team at lconradi@health.ucsd.edu for enrollment information.
Where is the NCT06180681 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06180681 clinical trial?
NCT06180681 is sponsored by University of California, San Diego. The principal investigator is Miguel Villodas, Ph.D. at San Diego State University. The trial plans to enroll 144 participants.