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

NCT ID: NCT06180681

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-05-31

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.

Detailed 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.

Conditions

Team-effectiveness Research; School-based Interventions; Attention Deficit/ Hyperactivity Disorder; Implementation Science

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Collaborative Life Skills Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Team-Enhanced Collaborative Life Skills Program

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Lauren Brookman-Frazee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Villodas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Linda Pfiffner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

IN STEP Children's Mental Health Center

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lilliana Conradi, BA

Role: CONTACT

lconradi@health.ucsd.edu

16196513154

Facility Contacts

Lilliana R Conradi

Role: primary

lconradi@health.ucsd.edu

619-651-3154

Other Identifiers

P50MH126231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

804142

Identifier Type: -

Identifier Source: org_study_id