Clinical trial NCT06180681: Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD
Official title: Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Team-effectiveness Research
School-based Interventions
Attention Deficit/ Hyperactivity Disorder
Implementation Science
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, San Francisco
name: San Diego State University
First posted: 2023-12-22
Enrollment: 144
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Acceptability, Feasibility, and Appropriateness of Intervention Measure
timeFrame: Post-intervention (immediately following intervention)
measure: Intervention Fidelity
timeFrame: Weekly during 3-month long intervention
measure: DBRC Completion
timeFrame: Weekly during 3-month long intervention
measure: Parenting Skill Use Diary
timeFrame: Daily during 3-month long intervention
measure: System Usability Scale (SUS)
timeFrame: Post-Intervention (immediately following intervention)
measure: Sustained Use of EBP Strategies
timeFrame: Follow-up (6 months after the end of intervention)
Secondary outcomes:
measure: Homework Problems Checklist
timeFrame: Pre-intervention (immediately before intervention begins), Post-intervention (immediately following intervention), Follow-up (6 months after the end of intervention).
measure: Academic Competency Evaluation Scale
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
measure: Children's Organizational Skills Scales
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
measure: Child and Adolescent Symptom Inventory-5
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
measure: Social Skills Improvement System
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
measure: Impairment Rating Scale
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Other outcomes:
measure: Card-Sorting Task
timeFrame: Post-intervention (immediately following intervention)
measure: Working Alliance Inventory Short Form (WAI-SR)
timeFrame: Post-intervention (immediately following intervention)
measure: McAllister Affect-Based Trust
timeFrame: Post-intervention (immediately following intervention)
measure: Collaboration & Satisfaction About Care Decisions (CSACD)
timeFrame: Post-intervention (immediately following intervention)
measure: Cohesion scale of Teamwork Quality
timeFrame: Post-intervention (immediately following intervention)
measure: Situation Awareness Rating Technique (SART)
timeFrame: Post-intervention (immediately following intervention)
measure: Parent Strategy Use Questionnaire
timeFrame: Weekly during 3-month long intervention
measure: Services for Children and Adolescents Parent Interview
timeFrame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Locations:
city: San Diego
country: United States
facility: IN STEP Children's Mental Health Center
state: California
Study officials:
affiliation: San Diego State University
name: Miguel Villodas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Linda Pfiffner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: