Autism Spectrum DisorderTEAMSNCT03380078
Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy
A study testing Teams Leadership Institute (TLI), Motivational Enhancement (TIPS for Training) and Classroom Pivotal Response Teaching (CPRT) in people with Autism Spectrum Disorder, run by University of California, Davis at 3 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Teams Leadership Institute (TLI), Motivational Enhancement (TIPS for Training) and Classroom Pivotal Response Teaching (CPRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Oct 2017to 31 Aug 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identified as Program Managers at an enrolled site or identified as Program Specialist in an enrolled program/district
- Employed at a participating program/district
- Employed for at least the next 7 months
- Has an eligible child on current caseload/classroom (see below)
- Did not participate in the AIM HI or CPRT effectiveness studies
- Inclusion Criteria for Parent Participants (enrolled in a dyad with participating provider)
Show all 10Show fewer
- Has a child age 3-13 years.
- Has a child with a current ASD diagnosis on record or a primary educational classification of autism as indicated in school records
- Identified as a leader or provider at enrolled site
- Linked to a participant leader (either as a supervisor or direct report)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of California, Davis
Sacramento, California, 95817
University of California, San Diego
San Diego, California, 92123
University of California, Los Angeles
Westwood, Los Angeles, California, 90095
About this study
Official title: Effectiveness of a Multi-Level Implementation Strategy for ASD Interventions
The purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS- Leadership Institute (TLI) module includes training to program/school district leaders in implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS) module applies Motivational Interviewing strategies to facilitate individual provider behavior change. TEAMS will be tested in combination with two clinical interventions in two community service setting contexts (1) AIM HI intervention in mental health programs and (2) CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will improve use of EBI by community providers.
Read the detailed description
Overview of Collaborative R01. The investigators propose to conduct two, coordinated studies testing the impact of the "Translating Evidence-based Interventions for ASD: A Multi-Level Implementation Strategy" (TEAMS). TEAMS focuses on improving implementation leadership, organizational climate (Teams Leadership Institute; TLI), and provider attitudes and engagement (TEAMS Individualized Provider Strategy for Training; TIPS) in order to improve two key implementation outcomes - ASD evidence-based intervention (EBI) fidelity, and subsequent child outcomes. The TLI module applies the LOCI ("Leadership and Organizational Change for Implementation") strategies, and the TIPS module applies MI (Motivational Interviewing) strategies to facilitate individual leader and provider level behavior change. These studies will use a randomized Hybrid implementation/effectiveness, Type 3, trial. Study #1 (PI: L Brookman-Frazee/UCSD) will test the TEAMS model with An Individualized Mental Health Intervention for ASD (AIM HI) in publicly-funded mental health services. Study #2 (PI: A Stahmer/UC Davis) will test TEAMS with Classroom Pivotal Response Teaching (CPRT) in school settings.
The Collaborative R01 mechanism will advance implementation science by allowing the research team to: 1) obtain a sufficient sample size to isolate the impact of individual and combined modules targeting different change mechanisms (implementation leadership/climate, attitudes); examine change mechanisms as mediators of outcomes; and provider background and organizational structure as moderators of outcomes; 2) enhance generalizability by testing TEAMS in combination with two clinical EBI in two public service systems critical for children with ASD; and maximize the diversity of the target population. Each site has unique expertise in one of the two EBI to be tested. The PIs have a strong history of collaboration and a clear management plan.
The Centers for Disease Control (CDC) estimates that 1 in 68 children have ASD. Long term outcomes for this populations are poor and the annual cost in the US is estimated to be $268 billion. Research on the effectiveness of methods to scale up EBI in routine care is critical to meet this growing public health need. The efficacy of a growing number of ASD EBI has been established. Emerging data from AIM HI and CPRT studies support the overall effectiveness of ASD EBI for improving child outcomes only when providers complete training and deliver interventions with fidelity. Unfortunately, adoption and provider training outcomes, considered key implementation outcomes, are variable (e.g., up to 35% of providers in our studies either do not complete training or have poor fidelity). These findings are especially concerning given the link between fidelity and child outcomes and the rapid increase of large-scale usual care implementation of EBI with little attention to training completion or fidelity, even with well-established training and consultation methods. Therefore, testing methods of improving implementation outcomes is key to ensuring positive child-level outcomes when EBI are implemented in routine care.
AIM HI and CPRT data indicate that (1) implementation leadership/climate and (2) provider attitudes towards EBI are promising targets of implementation interventions. The roles of both factors have been indicated for broader patient populations and also in current AIM HI and CPRT projects. As such, the project will apply two, established interventions (LOCI, MI) in the TEAMS model to target these specific mechanisms of change. This study will test the impact of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. A dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. The specific aims and hypotheses are:
- Test the effectiveness of the TEAMS modules individually and in combination on implementation outcomes when paired with two ASD EBI.
- Compared to standard ASD EBI training (control) and individual TEAMS modules (LEAD or PROV), the full TEAMS model will lead to more positive implementation outcomes for providers (training completion, fidelity), and children (improvements in targeted symptoms).
- Test the impact of TEAMS modules on organization and provider level mechanisms of change.
- TEAMS-LEAD will increase use of implementation leadership strategies and TEAMS-PROV will lead to greater changes in provider attitudes and engagement in EBI training.
- Identify moderators and mediators of implementation outcomes.
- Identify provider and organization characteristics that moderate implementation outcomes; and
- Identify provider and leader level mechanisms of change that mediate implementation outcomes.
Team Enhanced TLI Supplemental study Our supplemental study will examine whether a team-enhanced version of TLI results in better provider and child outcomes outcomes compared to TLI.
Impact: This implementation intervention has the potential to increase quality of care for ASD by improving effectiveness of EBI implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in mental health, educational and community services.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Teams Leadership Institute (TLI), Motivational Enhancement (TIPS for Training), Classroom Pivotal Response Teaching (CPRT), An Individualized Mental Health Intervention for ASD (AIM HI), Team-Enhanced Teams Leadership Institute (TLI)
- Keywords
- Implementation Mechanism, Autism Spectrum Disorder, Children's Mental Health Services, School Services
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teams Leadership Institute (TLI)Behavioural
TLI is training for leaders in how to improve implementation of evidence-based interventions in community settings. TLI includes 5 key components : 1. Assessment: The Implementation Leadership Scale (ILS) and Implementation Climate Scale (ICS) will be completed by first-level leaders participating in the intervention, his/her subordinates (i.e. providers) and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training in implementation leadership Leaders will develop a plan for using specific implementation support strategies. 3. Coaching: Weekly, brief (15-30 min) coaching calls keep leaders on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up : At month 4, leaders attend a 2-hour booster session . 5. Graduation: TLI programs will have a group-based graduation for the leaders and provider trainees at EBI training completion.
Motivational Enhancement (TIPS for Training)Behavioural
The TIPS module applies MI principles and strategies to address attitudinal barriers and improve engagement in training. I AIM HI and CPRT trainers (in the TIPS Conditions ) will incorporate MI during training and ongoing consultation/coaching with providers to increase provider engagement and problem solving throughout training: 1. Providers will receive a call designed to provide information about training and the intervention. 2. During the workshop, trainers will assess concerns about participating and will use reflective problem solving to address barriers . Trainers will work with the provider to develop a plan through the use of Planning Worksheets . 3. During each consultation , planning worksheets will be updated collaboratively with the provider. 4. Providers will receive a weekly motivational text to encourage on-going participation.
Classroom Pivotal Response Teaching (CPRT)Behavioural
CPRT is a naturalistic behavioral intervention adapted from pivotal response training (PRT) for use during classroom activities to target social, communication, behavior, and learning skills. CPRT is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. CPRT has an established training plan and the training curriculum that follows the manual. Training and coaching including standard EBI training is conducted by MA or postdoctoral level researchers with extensive training and experience with CPRT.
An Individualized Mental Health Intervention for ASD (AIM HI)Behavioural
A package of well-established, evidence-based behavioral strategies designed to reduce challenging behaviors in children served in MH service settings. AIM HI is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. AIM HI is a package of evidence-based parent-mediated and child focused strategies, designed to reduce behavior problems in children with ASD ages 5 to 13 served in MH programs. AIM HI has an established training plan and the training curriculum follows the manual. Training and coaching is conducted by MA or postdoctoral level researchers with extensive training and experience with AIM HI.
Team-Enhanced Teams Leadership Institute (TLI)Behavioural
TLI-2 enhances TLI training by (a) including additional team members important to EBI implementation (e.g., supervisors, support staff) and (b) including the team in the development of an implementation plan using a team charter process. TLI-2 includes 5 components : 1. Assessment: The Implementation Climate Scale (ICS) will be completed by team members, providers, and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training for the implementation team in implementation climate and development of an implementation plan. 3. Coaching: Bi-monthly, brief (15-30 min) coaching calls keep the team on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up: At month 4, team members attend a 2-hour booster session . 5. Graduation: TLI-2 programs will have a group-based graduation for the leaders and provider trainees at EBI training completion.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Programs assigned to the Standard condition will receive standard EBI training only Receives: Behavioral: Classroom Pivotal Response Teaching (CPRT); Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI) |
| TEAMS Leadership Institute (TLI) ONLY | Experimental | Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI. Receives: Behavioral: Teams Leadership Institute (TLI); Behavioral: Classroom Pivotal Response Teaching (CPRT); Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI); Behavioral: Team-Enhanced Teams Leadership Institute (TLI) |
| Motivational Enhancement (TIPS for Training) ONLY | Experimental | Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers. Receives: Behavioral: Motivational Enhancement (TIPS for Training); Behavioral: Classroom Pivotal Response Teaching (CPRT); Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI) |
| TIPS + TLI | Experimental | Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI Receives: Behavioral: Teams Leadership Institute (TLI); Behavioral: Motivational Enhancement (TIPS for Training); Behavioral: Classroom Pivotal Response Teaching (CPRT); Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Training Completion / Certification
Provider training/consultation completion will be measured through completion of requirements for certification, including attendance at workshops and training, completion of appropriate planning tools to program standards and meeting trainer rated fidelity of implementation standards.
Measured: Certification will be determine at POST training (6 mos)
Secondary outcomes (2)
Child Improvements on The Eyberg Child Behavior Inventory (ECBI)
The ECBI is a 36 item paper-and-pencil rating scales completed by parents that assesses the severity of conduct problems in children as well as the extent to which parents find the behaviors troublesome. It assesses the frequency of disruptive behaviors occurring in the home setting. It provides an Intensity Raw Score and a Problem Raw Score. Internal consistency reliability (Cronbach's alpha): .95 for the Intensity scale and .93 for the Problem scale; (2) Test-retest reliability: .75 to .86 for the Intensity scale and .75 to .88 for the Problem scale; (3) Inter-rater reliability: .86 for the Intensity scale and .79 for the Problem scale.
Measured: Child measures will be rated at PRE (intake) and POST intervention (6 mos)
Child Improvements on the PDD Behavior Inventory, Parent Extended Version (PDDBI-PX)
PDDBI-PX is a 188-item, paper-and-pencil rating scale completed by parents designed to assess symptoms of autism spectrum disorder and responsiveness to intervention in children. Subscales measure maladaptive (sensory/perceptual approach behaviors; fears; arousal problems; aggressiveness /behavior problems; social pragmatic problems) and adaptive behaviors (social approach; learning, memory and receptive language; phonological skills; pragmatic ability). Domain, composite, and total autism scores are provided. (1) Internal consistency reliability (Cronbach's alpha): ranged from .79 to .97 for all subscales; (2) Test-retest reliability: ranged from .38 to .91 over a 12-month interval; (3) Inter-rater reliability: Parent-Teacher ranged from .55-.67.
Measured: Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start20 Oct 2017
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will use a randomized factorial dismantling design to examine the independent and combined effectiveness of the TEAMS modules. MH programs (AIM HI study) and School districts (CPRT study) from San Diego, Sacramento, and LA Counties will be randomized to one of four conditions (STANDARD EBI-specific training only (control condition); TIPS (Motivational Module); TLI (LOCI Implementation Leadership Module). The Extension Study will use a "scale-out" open pilot design to examine the impact of a team enhanced TLI on provider and child outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380078
- Sponsor's protocol ID
- 990914
- Other IDs
- R01MH1198101, RO1MH1195001
- Acronym
- TEAMS
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2017
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1\. Submit an NIMH Data Archive Data Submission Agreement and work with NDCT staff to develop a data submission schedule and outline data elements to be submitted. 2. Data collection will be carefully organized and documented following best practices for data file management to allow for data sharing. 3. Include appropriate language in subject consent documents to allow for the broad sharing of data through NDCT. 4. Use our existing query to pull the required data fields (i.e. Child first, middle, last name, DOB, City of birth, gender) to obtain the Global Unique Identifier (GUIDs). 5\. Descriptive/raw data will be submitted semi-annually (January and June); submission of all other data will be done at the time of publication and/or prior to the end of the grant. Positive and negative results will be shared. In addition to the NDCT, we are open to accepting requests for data use subsequent to publication of primary research findings.
Publications
Stahmer AC, Lau AS, Roesch S, Rangel E, Aarons GA, Brookman-Frazee L. Understanding mechanisms of multi-level implementation strategies for autism interventions in a randomized trial across service systems. Implement Sci. 2025 Dec 15;20(1):54. doi: 10.1186/s13012-025-01466-z.
PubMed 41398285Brookman-Frazee L, Lau AS, Roesch SC, Jobin A, Chlebowski C, Mello M, Caplan B, Naar S, Aarons GA, Stahmer AC. Effectiveness of Multilevel Implementation Strategies for Autism Interventions: Outcomes of Two Linked Implementation Trials. J Am Acad Child Adolesc Psychiatry. 2025 Dec;64(12):1386-1400. doi: 10.1016/j.jaac.2025.01.003. Epub 2025 Jan 13.
PubMed 39814315Brookman-Frazee L, Stahmer AC. Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials. Implement Sci. 2018 May 9;13(1):66. doi: 10.1186/s13012-018-0757-2.
PubMed 29743090
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-Level Implementation Strategy for ASD Interventions
- ClinicalTrials.gov ID
- NCT03380078
- Acronym / sponsor ID
- TEAMS / 990914
- Conditions
- Autism Spectrum Disorder
- Keywords
- Implementation Mechanism, Autism Spectrum Disorder, Children's Mental Health Services, School Services
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,206 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Dec 2017 (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 purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS- Leadership Institute (TLI) module includes training to program/school district leaders in implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS) module applies Motivational Interviewing strategies to facilitate individual provider behavior change. TEAMS will be tested in combination with two clinical interventions in two community service setting contexts (1) AIM HI intervention in mental health programs and (2) CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will improve use of EBI by community providers.
Detailed description
Overview of Collaborative R01. The investigators propose to conduct two, coordinated studies testing the impact of the "Translating Evidence-based Interventions for ASD: A Multi-Level Implementation Strategy" (TEAMS). TEAMS focuses on improving implementation leadership, organizational climate (Teams Leadership Institute; TLI), and provider attitudes and engagement (TEAMS Individualized Provider Strategy for Training; TIPS) in order to improve two key implementation outcomes - ASD evidence-based intervention (EBI) fidelity, and subsequent child outcomes. The TLI module applies the LOCI ("Leadership and Organizational Change for Implementation") strategies, and the TIPS module applies MI (Motivational Interviewing) strategies to facilitate individual leader and provider level behavior change. These studies will use a randomized Hybrid implementation/effectiveness, Type 3, trial. Study #1 (PI: L Brookman-Frazee/UCSD) will test the TEAMS model with An Individualized Mental Health Intervention for ASD (AIM HI) in publicly-funded mental health services. Study #2 (PI: A Stahmer/UC Davis) will test TEAMS with Classroom Pivotal Response Teaching (CPRT) in school settings.
The Collaborative R01 mechanism will advance implementation science by allowing the research team to: 1) obtain a sufficient sample size to isolate the impact of individual and combined modules targeting different change mechanisms (implementation leadership/climate, attitudes); examine change mechanisms as mediators of outcomes; and provider background and organizational structure as moderators of outcomes; 2) enhance generalizability by testing TEAMS in combination with two clinical EBI in two public service systems critical for children with ASD; and maximize the diversity of the target population. Each site has unique expertise in one of the two EBI to be tested. The PIs have a strong history of collaboration and a clear management plan.
The Centers for Disease Control (CDC) estimates that 1 in 68 children have ASD. Long term outcomes for this populations are poor and the annual cost in the US is estimated to be $268 billion. Research on the effectiveness of methods to scale up EBI in routine care is critical to meet this growing public health need. The efficacy of a growing number of ASD EBI has been established. Emerging data from AIM HI and CPRT studies support the overall effectiveness of ASD EBI for improving child outcomes only when providers complete training and deliver interventions with fidelity. Unfortunately, adoption and provider training outcomes, considered key implementation outcomes, are variable (e.g., up to 35% of providers in our studies either do not complete training or have poor fidelity). These findings are especially concerning given the link between fidelity and child outcomes and the rapid increase of large-scale usual care implementation of EBI with little attention to training completion or fidelity, even with well-established training and consultation methods. Therefore, testing methods of improving implementation outcomes is key to ensuring positive child-level outcomes when EBI are implemented in routine care.
AIM HI and CPRT data indicate that (1) implementation leadership/climate and (2) provider attitudes towards EBI are promising targets of implementation interventions. The roles of both factors have been indicated for broader patient populations and also in current AIM HI and CPRT projects. As such, the project will apply two, established interventions (LOCI, MI) in the TEAMS model to target these specific mechanisms of change. This study will test the impact of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. A dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. The specific aims and hypotheses are:
- Test the effectiveness of the TEAMS modules individually and in combination on implementation outcomes when paired with two ASD EBI.
- Compared to standard ASD EBI training (control) and individual TEAMS modules (LEAD or PROV), the full TEAMS model will lead to more positive implementation outcomes for providers (training completion, fidelity), and children (improvements in targeted symptoms).
- Test the impact of TEAMS modules on organization and provider level mechanisms of change.
- TEAMS-LEAD will increase use of implementation leadership strategies and TEAMS-PROV will lead to greater changes in provider attitudes and engagement in EBI training.
- Identify moderators and mediators of implementation outcomes.
- Identify provider and organization characteristics that moderate implementation outcomes; and
- Identify provider and leader level mechanisms of change that mediate implementation outcomes.
Team Enhanced TLI Supplemental study Our supplemental study will examine whether a team-enhanced version of TLI results in better provider and child outcomes outcomes compared to TLI.
Impact: This implementation intervention has the potential to increase quality of care for ASD by improving effectiveness of EBI implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in mental health, educational and community services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- We will use a randomized factorial dismantling design to examine the independent and combined effectiveness of the TEAMS modules. MH programs (AIM HI study) and School districts (CPRT study) from San Diego, Sacramento, and LA Counties will be randomized to one of four conditions (STANDARD EBI-specific training only (control condition); TIPS (Motivational Module); TLI (LOCI Implementation Leadership Module). The Extension Study will use a "scale-out" open pilot design to examine the impact of a team enhanced TLI on provider and child outcomes.
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Classroom Pivotal Response Teaching (CPRT), Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI)Programs assigned to the Standard condition will receive standard EBI training only |
| TEAMS Leadership Institute (TLI) ONLY | Experimental | Behavioral: Teams Leadership Institute (TLI), Behavioral: Classroom Pivotal Response Teaching (CPRT), Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI), Behavioral: Team-Enhanced Teams Leadership Institute (TLI)Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI. |
| Motivational Enhancement (TIPS for Training) ONLY | Experimental | Behavioral: Motivational Enhancement (TIPS for Training), Behavioral: Classroom Pivotal Response Teaching (CPRT), Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI)Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers. |
| TIPS + TLI | Experimental | Behavioral: Teams Leadership Institute (TLI), Behavioral: Motivational Enhancement (TIPS for Training), Behavioral: Classroom Pivotal Response Teaching (CPRT), Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI)Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Identified as Program Managers at an enrolled site or identified as Program Specialist in an enrolled program/district
- Employed at a participating program/district
- Employed for at least the next 7 months
- Has an eligible child on current caseload/classroom (see below)
- Did not participate in the AIM HI or CPRT effectiveness studies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Teams Leadership Institute (TLI)TLI is training for leaders in how to improve implementation of evidence-based interventions in community settings. TLI includes 5 key components : 1. Assessment: The Implementation Leadership Scale (ILS) and Implementation Climate Scale (ICS) will be completed by first-level leaders participating in the intervention, his/her subordinates (i.e. providers) and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training in implementation leadership Leaders will develop a plan for using specific implementation support strategies. 3. Coaching: Weekly, brief (15-30 min) coaching calls keep leaders on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up : At month 4, leaders attend a 2-hour booster session . 5. Graduation: TLI programs will have a group-based graduation for the leaders and provider trainees at EBI training completion. | Behavioural | TEAMS Leadership Institute (TLI) ONLY, TIPS + TLI |
| Motivational Enhancement (TIPS for Training)The TIPS module applies MI principles and strategies to address attitudinal barriers and improve engagement in training. I AIM HI and CPRT trainers (in the TIPS Conditions ) will incorporate MI during training and ongoing consultation/coaching with providers to increase provider engagement and problem solving throughout training: 1. Providers will receive a call designed to provide information about training and the intervention. 2. During the workshop, trainers will assess concerns about participating and will use reflective problem solving to address barriers . Trainers will work with the provider to develop a plan through the use of Planning Worksheets . 3. During each consultation , planning worksheets will be updated collaboratively with the provider. 4. Providers will receive a weekly motivational text to encourage on-going participation. | Behavioural | Motivational Enhancement (TIPS for Training) ONLY, TIPS + TLI |
| Classroom Pivotal Response Teaching (CPRT)CPRT is a naturalistic behavioral intervention adapted from pivotal response training (PRT) for use during classroom activities to target social, communication, behavior, and learning skills. CPRT is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. CPRT has an established training plan and the training curriculum that follows the manual. Training and coaching including standard EBI training is conducted by MA or postdoctoral level researchers with extensive training and experience with CPRT. | Behavioural | Motivational Enhancement (TIPS for Training) ONLY, Standard, TEAMS Leadership Institute (TLI) ONLY, TIPS + TLI |
| An Individualized Mental Health Intervention for ASD (AIM HI)A package of well-established, evidence-based behavioral strategies designed to reduce challenging behaviors in children served in MH service settings. AIM HI is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. AIM HI is a package of evidence-based parent-mediated and child focused strategies, designed to reduce behavior problems in children with ASD ages 5 to 13 served in MH programs. AIM HI has an established training plan and the training curriculum follows the manual. Training and coaching is conducted by MA or postdoctoral level researchers with extensive training and experience with AIM HI. | Behavioural | Motivational Enhancement (TIPS for Training) ONLY, Standard, TEAMS Leadership Institute (TLI) ONLY, TIPS + TLI |
| Team-Enhanced Teams Leadership Institute (TLI)TLI-2 enhances TLI training by (a) including additional team members important to EBI implementation (e.g., supervisors, support staff) and (b) including the team in the development of an implementation plan using a team charter process. TLI-2 includes 5 components : 1. Assessment: The Implementation Climate Scale (ICS) will be completed by team members, providers, and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training for the implementation team in implementation climate and development of an implementation plan. 3. Coaching: Bi-monthly, brief (15-30 min) coaching calls keep the team on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up: At month 4, team members attend a 2-hour booster session . 5. Graduation: TLI-2 programs will have a group-based graduation for the leaders and provider trainees at EBI training completion. | Behavioural | TEAMS Leadership Institute (TLI) ONLY |
Primary outcome
Provider Training Completion / Certification
Time frame: Certification will be determine at POST training (6 mos)
Provider training/consultation completion will be measured through completion of requirements for certification, including attendance at workshops and training, completion of appropriate planning tools to program standards and meeting trainer rated fidelity of implementation standards.
2 secondary outcomes
Child Improvements on The Eyberg Child Behavior Inventory (ECBI)
Time frame: Child measures will be rated at PRE (intake) and POST intervention (6 mos)
Child Improvements on the PDD Behavior Inventory, Parent Extended Version (PDDBI-PX)
Time frame: Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos)
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 5 Dec 2025.
- Derived from this study: PubMed 41398285Stahmer AC, Lau AS, Roesch S, Rangel E, Aarons GA, Brookman-Frazee L. Understanding mechanisms of multi-level implementation strategies for autism interventions in a randomized trial across service systems. Implement Sci. 2025 Dec 15;20(1):54. doi: 10.1186/s13012-025-01466-z.
- Derived from this study: PubMed 39814315Brookman-Frazee L, Lau AS, Roesch SC, Jobin A, Chlebowski C, Mello M, Caplan B, Naar S, Aarons GA, Stahmer AC. Effectiveness of Multilevel Implementation Strategies for Autism Interventions: Outcomes of Two Linked Implementation Trials. J Am Acad Child Adolesc Psychiatry. 2025 Dec;64(12):1386-1400. doi: 10.1016/j.jaac.2025.01.003. Epub 2025 Jan 13.
- Derived from this study: PubMed 29743090Brookman-Frazee L, Stahmer AC. Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials. Implement Sci. 2018 May 9;13(1):66. doi: 10.1186/s13012-018-0757-2.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 1. Submit an NIMH Data Archive Data Submission Agreement and work with NDCT staff to develop a data submission schedule and outline data elements to be submitted. 2. Data collection will be carefully organized and documented following best practices for data file management to allow for data sharing. 3. Include appropriate language in subject consent documents to allow for the broad sharing of data through NDCT. 4. Use our existing query to pull the required data fields (i.e. Child first, middle, last name, DOB, City of birth, gender) to obtain the Global Unique Identifier (GUIDs). 5. Descriptive/raw data will be submitted semi-annually (January and June); submission of all other data will be done at the time of publication and/or prior to the end of the grant. Positive and negative results will be shared. In addition to the NDCT, we are open to accepting requests for data use subsequent to publication of primary research findings.
Related trials for Autism Spectrum Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teams Leadership Institute (TLI), Motivational Enhancement (TIPS for Training) and Classroom Pivotal Response Teaching (CPRT) in people with Autism Spectrum Disorder, run by University of California, Davis at 3 sites 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 10 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Training Completion / Certification (time frame: Certification will be determine at POST training (6 mos)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380078, which also lists 3 linked publications.
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 5 Dec 2025.