About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 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.
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.
Trial design
Parallel
Treatments tested in this trial
Team-Enhanced Collaborative Life Skills Program
BehavioralWe 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
BehavioralCLS 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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.
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.
Secondary outcomes
Homework Problems Checklist
Parents will complete the HPC, which consists of 20 items rated on a 4-point scale and has evidence of excellent internal consistency (αs between .90 and .92. assess child problems related to homework.75 (Langberg et al., 2010), which includes 20 items rated on a 4-point scale.
Academic Competency Evaluation Scale
Teachers will complete the Academic Enablers scales measures behaviors that support adaptive learning in the classroom. This subscale has evidence of excellent reliability. which has excellent psychometric properties including test-retest reliability (r=.96) and internal consistency (α=.98) for 3rd - 5th grade children
Children's Organizational Skills Scales
Parents and teachers will complete the COSS includes subscales assessing organizational skills, management of materials/supplies, and task planning skills (parent=58 items, teacher=35 items), with items are rated on a 4-point scale. The parent and teacher versions both have excellent internal consistency (αs=.98 and .97, respectively), test-retest reliability (rs = .99 and .94, respectively), and evidence of structural, convergent, and discriminant validity.
Child and Adolescent Symptom Inventory-5
Parents and teachers will complete the CASI-5 includes 78 items assessing DSM-5 symptoms of ADHD ODD, CD, Mood, and Anxiety. It has demonstrated adequate reliability (rs=.66-.78) and internal consistency (αs=.90-.94).
Other outcomes
Card-Sorting Task
Card sorting elicits individual mental models to understand how participants structure their knowledge. In open card sorts participants are provided with a set of key concepts and asked to sort them into categories. Each participant then creates a label for each category. In closed card sorts, participants are similarly given a set of key concepts, but participants are given pre-defined categories that each concept must be sorted into. Within team environments, card sorting can be used to examine the degree to which team members are thinking about key concepts in a similar manner (e.g., team mental models) by comparing the categories and sorted content across members. For this proposal, the card sorting task will assess CLS/CLS-T team mental models by examining perceptions of member roles, responsibilities, and goals across CLS/CLS-T team members. In doing so, the concepts contained in the card sort will be representative of specific CLS roles, task responsibilities, and goals.
Working Alliance Inventory Short Form (WAI-SR)
The WAI-SR will be completed by parents, teachers, and SMHPs at post-intervention. The WAI-SR is a 12-item version of the Horvath and Greenberg's (1989) Working Alliance Inventory. Each of the subscales will measure proposed mechanisms, while the overall scale will measure proposed outcomes. The 4-item Goal subscale will be used to determine team member agreement on goals for CLS daily behavior plan (goal specification). The 4-item Bond subscale will be used to determine the personal bond between CLS team members (trust). The overall scale score assesses the collaborative relationship between relevant parties; consensus and willingness by all to engage in and do the work that leads to improvement.
McAllister Affect-Based Trust
This 5-item scale will be completed by parents, teachers, and SMHPs at post-intervention. It assesses perceptions of affect-based trust amongst CLS members. Items center around individual's perceptions that team members can share ideas freely, that team members listen to one another, that team members care for one another, and that team members are invested in working well with one another.
Collaboration & Satisfaction About Care Decisions (CSACD)
The 6-item collaboration subscale will be completed by parents, teachers, and SMHPs at post-intervention to assesses collaboration, shared responsibilities for planning, open communication, and coordination. The 3-item satisfaction subscale assesses satisfaction with the decision making process, and satisfaction with the decision itself. Although originally developed about care decisions for intensive care patients, it has since been used to measure collaboration and satisfaction with treatment planning plans associated with the proposed team-based strategies.
Sponsors and contacts
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University of California, San Diego
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of California, San Francisco
Collaborator
San Diego State University
Collaborator