PMID- 29743090 OWN - NLM STAT- MEDLINE DCOM- 20190124 LR - 20231112 IS - 1748-5908 (Electronic) IS - 1748-5908 (Linking) VI - 13 IP - 1 DP - 2018 May 9 TI - Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials. PG - 66 LID - 10.1186/s13012-018-0757-2 [doi] LID - 66 AB - BACKGROUND: The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health need. This project includes two, coordinated studies testing the effectiveness of the Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy (TEAMS) model. TEAMS focuses on improving implementation leadership, organizational climate, and provider attitudes and motivation in order to improve two key implementation outcomes-provider training completion and intervention fidelity and subsequent child outcomes. The TEAMS Leadership Institute applies implementation leadership strategies and TEAMS Individualized Provider Strategies for training applies motivational interviewing strategies to facilitate provider and organizational behavior change. METHODS: A cluster randomized implementation/effectiveness Hybrid, type 3, trial with a dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. Study #1 will test the TEAMS model with AIM HI (An Individualized Mental Health Intervention for ASD) in publicly funded mental health services. Study #2 will test TEAMS with CPRT (Classroom Pivotal Response Teaching) in education settings. Thirty-seven mental health programs and 37 school districts will be randomized, stratified by county and study, to one of four groups (Standard Provider Training Only, Standard Provider Training + Leader Training, Enhanced Provider Training, Enhanced Provider Training + Leader Training) to test the effectiveness of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. Implementation outcomes including provider training completion, fidelity (coded by observers blind to group assignment) and child behavior change will be examined for 295 mental health providers, 295 teachers, and 590 children. DISCUSSION: This implementation intervention has the potential to increase quality of care for ASD in publicly funded settings by improving effectiveness of intervention implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in community services. TRIAL REGISTRATION: This study is registered with Clinicaltrials.gov ( NCT03380078 ). Registered 20 December 2017, retrospectively registered. FAU - Brookman-Frazee, Lauren AU - Brookman-Frazee L AD - Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093-0812, USA. lbrookman@ucsd.edu. AD - Child and Adolescent Services Research Center, 3020 Children's Way MC 5033, San Diego, CA, 92123, USA. lbrookman@ucsd.edu. FAU - Stahmer, Aubyn C AU - Stahmer AC AD - Child and Adolescent Services Research Center, 3020 Children's Way MC 5033, San Diego, CA, 92123, USA. AD - Department of Psychiatry and Behavioral Sciences, University of California, Davis, UC Davis MIND Institute, 2825 50th Street, Sacramento, CA, 95817, USA. LA - eng SI - ClinicalTrials.gov/NCT03380078 GR - R25 MH080916/MH/NIMH NIH HHS/United States GR - U54 HD079125/HD/NICHD NIH HHS/United States GR - R01MH111981/MH/NIMH NIH HHS/United States GR - R01MH111950/MH/NIMH NIH HHS/United States GR - R01 MH111981/MH/NIMH NIH HHS/United States GR - R01 MH111950/MH/NIMH NIH HHS/United States GR - R01 MH094317/MH/NIMH NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, U.S. Gov't, Non-P.H.S. DEP - 20180509 PL - England TA - Implement Sci JT - Implementation science : IS JID - 101258411 SB - IM MH - *Autism Spectrum Disorder MH - Child MH - *Community Mental Health Services MH - Humans MH - Mental Health MH - Program Evaluation/*methods MH - Randomized Controlled Trials as Topic MH - Retrospective Studies PMC - PMC5944167 OTO - NOTNLM OT - Autism OT - Education services OT - Fidelity OT - Implementation strategy OT - Leadership OT - Mental health services OT - Provider training COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by the University of California, San Diego, Human Research Protections Program (HRPP; Protocol # 161234) and is being relied upon by the University of California, Davis, and the University of California, Los Angeles. Informed consent will be obtained from all relevant participants. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/05/11 06:00 MHDA- 2019/01/25 06:00 PMCR- 2018/05/09 CRDT- 2018/05/11 06:00 PHST- 2018/02/28 00:00 [received] PHST- 2018/04/24 00:00 [accepted] PHST- 2018/05/11 06:00 [entrez] PHST- 2018/05/11 06:00 [pubmed] PHST- 2019/01/25 06:00 [medline] PHST- 2018/05/09 00:00 [pmc-release] AID - 10.1186/s13012-018-0757-2 [pii] AID - 757 [pii] AID - 10.1186/s13012-018-0757-2 [doi] PST - epublish SO - Implement Sci. 2018 May 9;13(1):66. doi: 10.1186/s13012-018-0757-2.