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

NCT06180681 | Recruiting DMC

• 2 other identifiers: 804142P50MH126231
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Acceptability, Feasibility, and Appropriateness of Intervention Measure

  This 12-item measure will be completed by parents, teachers, and SMHPs at post-intervention to assess the extent to which the CLS intervention, Team Charters, Handoff protocols, and Team Progress Monitoring and Assessment procedures are appealing, liked, and welcomed in their setting (acceptability); fitting, suitable, and applicable in their setting (appropriateness); possible and doable in their setting (feasible).

  Post-intervention (immediately following intervention)

• Intervention Fidelity

  Fidelity monitoring observation checklists will be adapted in Year 1 from those previously developed for CLS to measure fidelity of SMHP training in standard CLS and CLS-T, as well as SMHP implementation of each component of the CLS and the TBIS. A separate measure of SMHP competence in executing the treatment will be adapted from the CLS Implementation Quality Form used in previous trials, which will be completed by the trainer after each "live" observation. Items assess clarity of skill presentation, thoroughness of homework review, use of practical examples, and effectiveness of handout review rated by the trainer on a 1- 5 scale (from 1=not at all to 5= most). The child-group version includes items such as use of effective commands, prompts and praise, and clarity of skill presentation rated by the trainer on a 1-5 scale (from 1=not at all to 5=most). A second research team member (blinded to group assignment) will rate 15% of sessions to estimate inter-rater reliability.

  Weekly during 3-month long intervention

• DBRC Completion

  The proportion of school days the school eDBRC was implemented each week will be calculated based on the number of completed eDBRCs, divided by the overall count of possible school days during the week, as we have done in previous trials.13 School holidays (coded from the online student calendar for each school), child absence, special school events/field trips and substitute teacher days (when noted on the eDBRC) will not be included in the overall count of possible school days during the week.

  Weekly during 3-month long intervention

• Parenting Skill Use Diary

  This 2-item measures assesses parent's use of behavioral strategies in responses to adaptive, as well as maladaptive child behaviors. It is completed in a daily diary format.

  Daily during 3-month long intervention

• System Usability Scale (SUS)

  Parents, teachers, and SMHPs will completed this 10-item agnostic scale assessing product usability, with SUS scores above 80 indicating good usability.57-59 SUS will be completed by SMHPs, teachers, and parents after pre-intervention focus groups, and at the post-intervention assessment of the randomized trial to assess usability of each TBIS.

  Post-Intervention (immediately following intervention)

• Sustained Use of EBP Strategies

  SMHPs, parents, and teachers will each complete customized measures that query whether they are still using the skills learned in CLS during the subsequent school year, with new students/teachers. The scales will be adapted from scales used in previous clinical trials evaluating CLS and will include questions about use of the TBIS.

  Follow-up (6 months after the end of intervention)

Secondary Outcomes (6)

• Homework Problems Checklist

  Pre-intervention (immediately before intervention begins), Post-intervention (immediately following intervention), Follow-up (6 months after the end of intervention).

• Academic Competency Evaluation Scale

  Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

• Children's Organizational Skills Scales

  Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

• Child and Adolescent Symptom Inventory-5

  Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

• Social Skills Improvement System

  Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)

Other Outcomes (8)

• Card-Sorting Task

  Post-intervention (immediately following intervention)

• Working Alliance Inventory Short Form (WAI-SR)

  Post-intervention (immediately following intervention)

• McAllister Affect-Based Trust

  Post-intervention (immediately following intervention)

Study Arms (2)

Standard Collaborative Life Skills Program Implementation

ACTIVE COMPARATOR

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.

Behavioral: Standard Collaborative Life Skills Program

Team-Enhanced Collaborative Life Skills Program Implementation

EXPERIMENTAL

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.

Behavioral: Team-Enhanced Collaborative Life Skills Program

Interventions

Team-Enhanced Collaborative Life Skills Program 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.

Team-Enhanced Collaborative Life Skills Program Implementation

Standard Collaborative Life Skills Program 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.

Standard Collaborative Life Skills Program Implementation

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Youth ages of 7-11 years (2-5th grade) who are attending a participating school
• Child referred by a school mental health provider (SMHP) with apparent ADHD-related problems,
• ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory
• ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
• Caretaker and teacher consent to participate in treatment and child provides assent.

You may not qualify if:

• 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
• 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)
• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Francisco: collaborator
• San Diego State University: collaborator

Study Sites (1)

IN STEP Children's Mental Health Center

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Miguel Villodas, Ph.D.

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Linda Pfiffner, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilliana Conradi, BA

CONTACT

16196513154; lconradi@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

US (1)