NCT03380078

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,206

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Oct 2017Aug 2027

Study Start

First participant enrolled

October 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

9.9 years

First QC Date

November 27, 2017

Last Update Submit

December 3, 2025

Conditions

Keywords

Implementation MechanismAutism Spectrum DisorderChildren's Mental Health ServicesSchool Services

Outcome Measures

Primary Outcomes (1)

  • 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.

    Certification will be determine at POST training (6 mos)

Secondary Outcomes (2)

  • Child Improvements on The Eyberg Child Behavior Inventory (ECBI)

    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)

    Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos)

Other Outcomes (4)

  • Training/consultation attendance

    Attendance will be tracked throughout intervention training and compiled at Post Intervention (6 months)

  • Evidence-Based Practice Attitude Scale (EBPAS-15)

    Measures will be completed at PRE (intake) and POST intervention (6 mos)

  • Implementation Leadership Scales

    Measures will be completed at PRE (intake) and POST intervention (6 mos)

  • +1 more other outcomes

Study Arms (4)

Standard

ACTIVE COMPARATOR

Programs assigned to the Standard condition will receive standard EBI training only

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.

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.

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

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)

Interventions

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.

Motivational Enhancement (TIPS for Training) ONLYStandardTEAMS Leadership Institute (TLI) ONLYTIPS + TLI

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.

Motivational Enhancement (TIPS for Training) ONLYStandardTEAMS Leadership Institute (TLI) ONLYTIPS + 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.

TEAMS Leadership Institute (TLI) ONLY

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.

TEAMS Leadership Institute (TLI) ONLYTIPS + TLI

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.

Motivational Enhancement (TIPS for Training) ONLYTIPS + TLI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Diego

San Diego, California, 92123, United States

Location

University of California, Los Angeles

Westwood, Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • 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.

  • Brookman-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.

  • Brookman-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.

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Coders assessing provider outcomes are masked from study condition and aims.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 20, 2017

Study Start

October 20, 2017

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
At completion of study
Access Criteria
we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations