Team-effectiveness ResearchNCT06180681
Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD
A study testing Team-Enhanced Collaborative Life Skills Program and Standard Collaborative Life Skills Program in people with Team-effectiveness Research and School-based Interventions, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Team-effectiveness Research, School-based Interventions, Attention Deficit/ Hyperactivity Disorder
- What is being tested?
- Team-Enhanced Collaborative Life Skills Program and Standard Collaborative Life Skills Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IN STEP Children's Mental Health Center
San Diego, California, 92123
Lilliana R Conradi, 16196513154, lconradi@health.ucsd.edu
About this study
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.
Read the 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
- Being tested
- Team-Enhanced Collaborative Life Skills Program, Standard Collaborative Life Skills Program
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Enhanced Collaborative Life Skills ProgramBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Team-Enhanced Collaborative Life Skills Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up (6 months after the end of intervention)
Secondary outcomes (6)
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.
Measured: Pre-intervention (immediately before intervention begins), Post-intervention (immediately following intervention), Follow-up (6 months after the end of intervention).
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
Measured: 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
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.
Measured: 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
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).
Measured: 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
Parents and teachers will complete the Social Skills scale (standard scores) will be used in analyses. The SSIS has excellent psychometric properties, including high internal consistency for the parent and teacher versions (.94 and .95, respectively) adequate test-retest reliability (.84 and .81 for teacher and parent versions respectively) and has been sensitive to CLS in previous trials
Measured: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Impairment Rating Scale
Parents and teachers will report about students' functioning (e.g., academic, behavioral, peer, etc.) on the Impairment Rating Scale using a 6-point scale (0 = "needs no treatment" to 6 = "definitely requires treatment") with ratings of > 2 indicating impairment.
Measured: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Team-effectiveness ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Francisco, San Diego State University
- Responsible party
- Principal investigator, Lauren Brookman-Frazee, University of California, San Diego
- Investigators
- Miguel Villodas, Ph.D., Principal investigator, San Diego State UniversityLinda Pfiffner, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180681
- Sponsor's protocol ID
- 804142
- Other IDs
- P50MH126231
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD
- ClinicalTrials.gov ID
- NCT06180681
- Acronym / sponsor ID
- 804142
- Conditions
- Team-effectiveness Research, School-based Interventions, Attention Deficit/ Hyperactivity Disorder, Implementation Science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Francisco, San Diego State University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Collaborative Life Skills Program Implementation | Active comparator | Behavioral: Standard Collaborative Life Skills ProgramCLS 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 | Experimental | Behavioral: Team-Enhanced Collaborative Life Skills ProgramWe 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-Enhanced Collaborative Life Skills ProgramWe 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. | Behavioural | Team-Enhanced Collaborative Life Skills Program Implementation |
| Standard Collaborative Life Skills ProgramCLS 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. | Behavioural | Standard Collaborative Life Skills Program Implementation |
Primary outcome
Acceptability, Feasibility, and Appropriateness of Intervention Measure
Time frame: Post-intervention (immediately following intervention)
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
Time frame: Weekly during 3-month long intervention
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
Time frame: Weekly during 3-month long intervention
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
Time frame: Daily during 3-month long intervention
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.
System Usability Scale (SUS)
Time frame: Post-Intervention (immediately following intervention)
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.
Sustained Use of EBP Strategies
Time frame: Follow-up (6 months after the end of intervention)
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.
6 secondary outcomes
Homework Problems Checklist
Time frame: Pre-intervention (immediately before intervention begins), Post-intervention (immediately following intervention), Follow-up (6 months after the end of intervention).
Academic Competency Evaluation Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Impairment Rating Scale
Time frame: Pre-intervention (immediately before intervention begins), post-intervention (immediately following intervention), and follow up (6 months after the end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Villodas, Ph.D. principal investigator
San Diego State University
Linda Pfiffner, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-Enhanced Collaborative Life Skills Program and Standard Collaborative Life Skills Program in people with Team-effectiveness Research and School-based Interventions, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilliana Conradi, BA (16196513154, lconradi@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability, Feasibility, and Appropriateness of Intervention Measure (time frame: Post-intervention (immediately following intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.