Clinical trial NCT03380078: Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy
Official title: Effectiveness of a Multi-Level Implementation Strategy for ASD Interventions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Implementation Mechanism
Autism Spectrum Disorder
Children's Mental Health Services
School Services
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2017-12-20
Enrollment: 1206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

1. Test the effectiveness of the TEAMS modules individually and in combination on implementation outcomes when paired with two ASD EBI.

   a) 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).
2. Test the impact of TEAMS modules on organization and provider level mechanisms of change.

   a) 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.
3. Identify moderators and mediators of implementation outcomes.

   1. Identify provider and organization characteristics that moderate implementation outcomes; and
   2. 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.

Eligibility criteria: The combined multi-level sample for both studies will include 74 programs/districts, 148 agency/district leaders, 590 providers (average of 8 per program/district) and 590 parents (1 per provider). It is estimated that an additional 590 participants will complete the 360 Organizational Assessment. Providers are expected to be approximately 85% female and 35% Hispanic. Parent participants are expected to be approximately 80% female and 60% Hispanic.

Mental health programs will be those providing publicly funded psychotherapy services to children in San Diego, Sacramento and LA Counties for in person training and throughout California for distance training. Districts will be those providing public education services to elementary school children with ASD in San Diego, Sacramento and LA Counties for in person training and throughout California for distance training.

Inclusion Criteria for Leaders

(1) Identified as Program Managers at an enrolled site or identified as Program Specialist in an enrolled program/district

Inclusion Criteria for Providers

1. Employed at a participating program/district
2. Employed for at least the next 7 months
3. Has an eligible child on current caseload/classroom (see below)
4. Did not participate in the AIM HI or CPRT effectiveness studies

Inclusion Criteria for Parent Participants (enrolled in a dyad with participating provider)

1. Has a child age 3-13 years.
2. Has a child with a current ASD diagnosis on record or a primary educational classification of autism as indicated in school records

Inclusion Criteria for 360 degree Organizational Assessment

1. Identified as a leader or provider at enrolled site
2. Linked to a participant leader (either as a supervisor or direct report)

Primary outcomes:
measure: Provider Training Completion / Certification
timeFrame: Certification will be determine at POST training (6 mos)
Secondary outcomes:
measure: Child Improvements on The Eyberg Child Behavior Inventory (ECBI)
timeFrame: Child measures will be rated at PRE (intake) and POST intervention (6 mos)
measure: Child Improvements on the PDD Behavior Inventory, Parent Extended Version (PDDBI-PX)
timeFrame: Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos)
Other outcomes:
measure: Training/consultation attendance
timeFrame: Attendance will be tracked throughout intervention training and compiled at Post Intervention (6 months)
measure: Evidence-Based Practice Attitude Scale (EBPAS-15)
timeFrame: Measures will be completed at PRE (intake) and POST intervention (6 mos)
measure: Implementation Leadership Scales
timeFrame: Measures will be completed at PRE (intake) and POST intervention (6 mos)
measure: Implementation Climate Scales
timeFrame: Measures will be completed at PRE (intake) and POST intervention (6 mos)
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Westwood
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
citation: 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.