Recruiting

Collaborative Intervention

Sponsor:

UCLA

Code:

NCT06180681

Conditions

Team-effectiveness Research

School-based Interventions

Attention Deficit/ Hyperactivity Disorder

Implementation Science

Eligibility Criteria

Sex: All

Age: 7 - 11

Healthy Volunteers: Not accepted

Interventions

Team-Enhanced Collaborative Life Skills Program

Standard Collaborative Life Skills Program

Study Details

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.

Conditions

Team-effectiveness Research

School-based Interventions

Attention Deficit/ Hyperactivity Disorder

Implementation Science

Study ID

NCT06180681

Start date

Jan 1, 2024

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 11

Healthy Volunteers: Not accepted

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 or Spanish. Note: Participants will need to be able to read/speak English or Spanish because all measures are in English or Spanish, and the intervention will be conducted in English or Spanish. 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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Collaborative Life Skills Program Implementation

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.

experimental: Team-Enhanced Collaborative Life Skills Program Implementation

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.

Interventions

Team-Enhanced Collaborative Life Skills Program

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.

Standard Collaborative Life Skills Program

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.

Primary outcome measure

  • Acceptability, Feasibility, and Appropriateness of Intervention Measure [ Time Frame: Post-intervention (immediately following intervention) ]
  • Intervention Fidelity [ Time Frame: Weekly during 3-month long intervention ]
  • DBRC Completion [ Time Frame: Weekly during 3-month long intervention ]
  • Parenting Skill Use Diary [ Time Frame: Daily during 3-month long intervention ]
  • System Usability Scale (SUS) [ Time Frame: Post-Intervention (immediately following intervention) ]
  • Sustained Use of EBP Strategies [ Time Frame: Follow-up (6 months after the end of intervention) ]

Central Contacts and Locations

Central contacts

Lilliana Conradi, BA

16196513154lconradi@health.ucsd.edu

Locations

IN STEP Children's Mental Health Center

Recruiting

San Diego, California, United States, 92123

Contacts

Lilliana R Conradi

16196513154lconradi@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-30.