Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: Classroom Pivotal Response Teaching (CPRT)Behavioral: Motivational Enhancement (TIPS for Training)Behavioral: Teams Leadership Institute (TLI)Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI)Behavioral: Team-Enhanced Teams Leadership Institute (TLI)
- Registration Number
- NCT03380078
- Lead Sponsor
- University of California, Davis
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Classroom Pivotal Response Teaching (CPRT) Programs assigned to the Standard condition will receive standard EBI training only Motivational Enhancement (TIPS for Training) ONLY Motivational Enhancement (TIPS for Training) Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers. TIPS + TLI Motivational Enhancement (TIPS for Training) Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI TIPS + TLI Classroom Pivotal Response Teaching (CPRT) Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI Standard 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 Classroom Pivotal Response Teaching (CPRT) Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI. TEAMS Leadership Institute (TLI) ONLY 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 Classroom Pivotal Response Teaching (CPRT) Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers. Motivational Enhancement (TIPS for Training) ONLY An Individualized Mental Health Intervention for ASD (AIM HI) Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers. TEAMS Leadership Institute (TLI) ONLY Teams Leadership Institute (TLI) Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI. TIPS + TLI Teams Leadership Institute (TLI) Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI TEAMS Leadership Institute (TLI) ONLY An Individualized Mental Health Intervention for ASD (AIM HI) Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI. TIPS + TLI 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
- Primary Outcome Measures
Name Time Method Provider Training Completion / Certification 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.
- Secondary Outcome Measures
Name Time Method Child Improvements on The Eyberg Child Behavior Inventory (ECBI) Child measures will be rated at PRE (intake) and POST intervention (6 mos) 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.
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) 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.
Trial Locations
- Locations (3)
University of California, Davis
🇺🇸Sacramento, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
University of California, Los Angeles
🇺🇸Westwood, California, United States