Michigan Model for HealthTM Learning to Enhance and Adapt for Prevention (Mi-LEAP): protocol of a pilot randomized trial comparing Enhanced Replicating Effective Programs versus standard implementation to deliver an evidence-based drug use prevention curriculum

Andria B Eisman, Lawrence A Palinkas, Christine Koffkey, Todd I Herrenkohl, Umaima Abbasi, Judy Fridline, Leslie Lundahl, Amy M Kilbourne, Andria B Eisman, Lawrence A Palinkas, Christine Koffkey, Todd I Herrenkohl, Umaima Abbasi, Judy Fridline, Leslie Lundahl, Amy M Kilbourne

Abstract

Background: School-based drug use prevention programs have demonstrated notable potential to reduce the onset and escalation of drug use, including among youth at risk of poor outcomes such as those exposed to trauma. Researchers have found a robust relationship between intervention fidelity and participant (i.e., student) outcomes. Effective implementation of evidence-based interventions, such as the Michigan Model for HealthTM (MMH), is critical to achieving desired public health objectives. Yet, a persistent gap remains in what we know works and how to effectively translate these findings into routine practice. The objective of this study is to design and test a multi-component implementation strategy to tailor MMH to meet population needs (i.e., students exposed to trauma), and improve the population-context fit to enhance fidelity and effectiveness.

Methods: Using a 2-group, mixed-method randomized controlled trial design, this study will compare standard implementation versus Enhanced Replicating Effective Programs (REP) to deliver MMH. REP is a theoretically based implementation strategy that promotes evidence-based intervention (EBI) fidelity through a combination of EBI curriculum packaging, training, and as-needed technical assistance and is consistent with standard MMH implementation. Enhanced REP will tailor the intervention and training to integrate trauma-informed approaches and deploy customized implementation support (i.e., facilitation). The research will address the following specific aims: (1) design and test an implementation strategy (Enhanced REP) to deliver the MMH versus standard implementation and evaluate feasibility, acceptability, and appropriateness using mixed methods, (2) estimate the costs and cost-effectiveness of Enhanced REP to deliver MMH versus standard implementation.

Discussion: This research will design and test a multi-component implementation strategy focused on enhancing the fit between the intervention and population needs while maintaining fidelity to MMH core functions. We focus on the feasibility of deploying the implementation strategy bundle and costing methods and preliminary information on cost input distributions. The substantive focus on youth at heightened risk of drug use and its consequences due to trauma exposure is significant because of the public health impact of prevention. Pilot studies of implementation strategies are underutilized and can provide vital information on designing and testing effective strategies by addressing potential design and methods uncertainties and the effects of the implementation strategy on implementation and student outcomes.

Trial registration: NCT04752189-registered on 8 February 2021 on ClinicalTrials.gov PRS.

Keywords: Adolescents; Adverse childhood experiences; Cost-effectiveness; Costs; Drug use disorders; Implementation science; Prevention.

Conflict of interest statement

The authors declare they have no competing interests to report.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Conceptual model for applying implementation strategies to evidence-based interventions (EBIs), adapted from Proctor et al. [19]; Lyon & Bruns [20]
Fig. 2
Fig. 2
Group randomized controlled trial pilot study design. ATOD: alcohol, tobacco and other drugs
Fig. 3
Fig. 3
Aim 1 convergent mixed methods design (adapted from Creswell & Plano-Clark [58])

References

    1. Herrenkohl T, Hong S, Verbrugge B. Trauma-informed programs based in schools: linking concepts to practices and assessing the evidence. Am J Community Psychol. 2019;64(3–4):373–388. doi: 10.1002/ajcp.12362.
    1. Temkin D, Harper K, Stratford B, Sacks V, Rodriguez Y, Bartlett JD. Moving policy toward a whole school, whole community, whole child approach to support children who have experienced trauma. J Sch Health. 2020;90(12):940–947. doi: 10.1111/josh.12957.
    1. O’Connell M, Boat T, Warner K, Warner K. Preventing mental, emotional and behavioral disorders among young people: progress and possibilities. Washington, DC: Board on Children, Youth, and Families, Division of Behavioral and Social Sciences and Education, National Academies Press; 2009. p. 549.
    1. Greenberg M. School-based prevention: current status and future challenges. Effect Educ. 2010;2(1):27–52. doi: 10.1080/19415531003616862.
    1. Hale D, Fitzgerald-Yau N, Viner R. A systematic review of effective interventions for reducing multiple health risk behaviors in adolescence. Am J Public Health. 2014;104(5):e19–e41. doi: 10.2105/AJPH.2014.301874.
    1. Hill KG, Bailey JA, Steeger CM, Hawkins JD, Catalano RF, Kosterman R, et al. Outcomes of childhood preventive intervention across 2 generations: a nonrandomized controlled trial. JAMA Pediatr. 2020;174(8):764–771. doi: 10.1001/jamapediatrics.2020.1310.
    1. Lee R, Gortmaker S. Health dissemination and implementation within schools. In: Brownson R, Colditz G, Proctor E, editors. Dissemination and implementation research in health: translating science to practice. 2. New York: Oxford University Press; 2018. pp. 401–416.
    1. SAMHSA . Trauma-informed approach and trauma-specific interventions. Substance Abuse and Mental Health Services Administration (SAMHSA); 2014.
    1. Bethell CD, Newacheck P, Hawes E, Halfon N. Adverse childhood experiences: assessing the impact on health and school engagement and the mitigating role of resilience. Health Aff. 2014;33(12):2106–2115. doi: 10.1377/hlthaff.2014.0914.
    1. CDC . Preventing Adverse Childhood Experiences (ACES): leveraging the best available evidence. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2019.
    1. Klevens J, Metzler M. Bringing a health equity perspective to the prevention of child abuse and neglect. In: Lonne B, Higgins D, Scott D, Herrenkohl, editors. Re-visioning public health approaches for protecting children. 2019. pp. 330–359.
    1. Chafouleas SM, Johnson AH, Overstreet S, Santos NM. Toward a Blueprint for Trauma-Informed Service Delivery in Schools. School Mental Health. 2016;8(1):144–62.
    1. Durlak JA, Weissberg RP, Dymnicki AB, Taylor RD, Schellinger KB. The impact of enhancing students’ social and emotional learning: a meta-analysis of school-based universal interventions. Child Dev. 2011;82(1):405–32.
    1. Castro FG, Yasui M. Advances in EBI Development for Diverse Populations: Towards a Science of Intervention Adaptation. Prev Sci. 2017;18(6):623–9.
    1. Durlak J, DuPre E. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008;41(3):327. doi: 10.1007/s10464-008-9165-0.
    1. U.S. Department of Education . Prevalence and implementation fidelity of research-based prevention programs in public schools: final report. Washington, D.C.: U.S. Department of Education, Office of Planning, Evaluation and Policy Development, Policy and Programs Study Service; 2011.
    1. Grol R, Grimshaw J. Evidence-based implementation of evidence-based medicine. Jt Comm J Qual Improv. 1999;25(10):503–513.
    1. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implementation Science. 2013;8(1).
    1. Proctor E, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: An emerging science with conceptual, methodological, and training challenges. Administration and Policy in Mental Health and Mental Health Services Research. 2009;36(1):24–34.
    1. Lyon A, Bruns E. From Evidence to Impact: Joining Our Best School Mental Health Practices with Our Best Implementation Strategies. School Mental Health. 2019;11(1):106–14.
    1. O’Neill J, Clark J, Jones J. Promoting mental health and preventing substance abuse and violence in elementary students: a randomized control study of the michigan model for health. J Sch Health. 2011;81(6):320–330. doi: 10.1111/j.1746-1561.2011.00597.x.
    1. Shope J, Copeland L, Maharg R, Dielman T. Effectiveness of a high school alcohol misuse prevention program. Alcohol Clin Exp Res. 1996;20(5):791–798. doi: 10.1111/j.1530-0277.1996.tb05253.x.
    1. Bandura A. Human agency in social cognitive theory. Am Psychol. 1989;44(9):1175–1184. doi: 10.1037/0003-066X.44.9.1175.
    1. Rosenstock IM. Historical origins of the health belief model. Health Educ Monogr. 1974;2(4):328–335. doi: 10.1177/109019817400200403.
    1. CASEL. Program Guide CASEL: Collaborative for Academic Social and Emotional Learning. [Internet]. Program Guide. 2022. Available from: . Cited 8 Feb 2022.
    1. CDC. National Health Education Standards [Internet]. CDC Healthy Schools. 2019. Available from: . Cited 21 Dec 2021.
    1. Rockhill S. Use of the Michigan Model for Health Curriculum among Michigan Public Schools. Lansing MI; 2017.
    1. Durlak J, Weissberg R, Pachan M. A meta-analysis of after-school programs that seek to promote personal and social skills in children and adolescents. Am J Community Psychol. 2010;45(3–4):294–309. doi: 10.1007/s10464-010-9300-6.
    1. Eisman A, Kilbourne A, Ngo Q, Fridline K, Zimmerman M, Greene D, et al. Implementing a state-adopted high school health curriculum: a case study. J Sch Health. 2020;90(6):447–456. doi: 10.1111/josh.12892.
    1. Neumann M, Sogolow E. Replicating effective programs: HIV/AIDS prevention technology transfer. AIDS education and prevention: official publication of the International Society for AIDS Education. 2000;12(5 Suppl):35–48.
    1. Kilbourne AM, Smith SN, Choi SY, Koschmann E, Liebrecht C, Rusch A, et al. Adaptive School-based Implementation of CBT (ASIC): clustered-SMART for building an optimized adaptive implementation intervention to improve uptake of mental health interventions in schools. Implementation Sci. 2018;13(1):119.
    1. Bandura A. Social learning theory. Prentice-Hall; 1977.
    1. Rogers E. Diffusion of innovations. 2003.
    1. Kilbourne AM, Almirall D, Eisenburg D, Waxmonsky J, Goodrich DE, Fortney JC, et al. Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program. Implement Sci. 2014;9(1):132. doi: 10.1186/s13012-014-0132-x.
    1. Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2015;11(1):33. doi: 10.1186/s13012-016-0398-2.
    1. Kilbourne AM, Almirall D, Goodrich DE, et al. Enhancing outreach for persons with serious mental illness: 12-month results from a cluster randomized trial of an adaptive implementation strategy. Implement Sci. 2014;9:163. Published 2014 Dec 28. 10.1186/s13012-014-0163-3.
    1. Raghavan R. Dissemination and implementation research in health: translating science to practice. 2. New York: Oxford University Press; 2018. The role of economic evaluation in dissemination and implementation research.
    1. Eisman A, Kilbourne A, Dopp A, Saldana L, Eisenberg D. Economic evaluation in implementation science: making the business case for implementation strategies. Psychiatry Res. 2020;283:112433. doi: 10.1016/j.psychres.2019.06.008.
    1. Kilbourne A, Goodrich D, Nord K, Van Poppelen C, Kyle J, Bauer M, et al. Long-Term Clinical Outcomes from a Randomized Controlled Trial of Two Implementation Strategies to Promote Collaborative Care Attendance in Community Practices. Administration and policy in mental health. 2015;42(5):642–53.
    1. Eisman A, Kiperman S, Rupp L, Kilbourne A, Palinkas L. Understanding Key Implementation Determinants for a School-Based Universal Prevention Intervention: A qualitative study. Translational Behavioral Medicine. 2022;12(3):411–22.
    1. Eisman A, Palinkas L, Herrenkohl T, Boyd C, Kilbourne A. Meeting the needs of trauma-exposed youth: enhancing implementation fidelity to a state-wide health curriculum. Washington DC: Academy Health and NIH; 2020.
    1. Baumann A, Cabassa L. Reframing implementation science to address inequities in healthcare delivery. BMC Health Serv Res. 2020;20(190):9.
    1. LeTendre M, Reed M. The effect of adverse childhood experience on clinical diagnosis of a substance use disorder: results of a nationally representative study. Subst Use Misuse. 2017;52(6):689–697. doi: 10.1080/10826084.2016.1253746.
    1. Pearson N, Naylor P, Ashe M, Fernandez M, Yoong S, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020;6(1):167. doi: 10.1186/s40814-020-00634-w.
    1. Eisman A, Kilbourne A, Greene D, Walton M, Cunningham R. The user-program interaction: how teacher experience shapes the relationship between intervention packaging and fidelity to a state-adopted health curriculum. Prev Sci. 2020;21(6):820–829. doi: 10.1007/s11121-020-01120-8.
    1. United Health Foundation. Adverse childhood experiences: America’s health rankings analysis of U.S. HHS, HRSA, Maternal and Child Health Bureau (MCHB), Child and Adolescent Health Measurement Initiative (CAHMI), National Survey of Children’s Health Indicator Data Set, Data Resource Center for Child and Adolescent Health. 2020. Available from: . Cited 2020 Jul 10.
    1. MiSHCA. MiSHCA. Available from: . Cited 2021 Feb 25.
    1. Escoffery C, Lebow-Skelley E, Haardoerfer R, Boing E, Udelson H, Wood R, et al. A systematic review of adaptations of evidence-based public health interventions globally. Implement Sci. 2018;13(1):125. doi: 10.1186/s13012-018-0815-9.
    1. Wiltsey Stirman S, Baumann A, Miller C. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019;14(1):58. doi: 10.1186/s13012-019-0898-y.
    1. Kirchner J, Waltz T, Powell B, Smith J, Proctor E. Implementation strategies. In: Brownson R, Colditz G, Proctor E, editors. Dissemination and implementation research in health: translating science to practice. 2. New York: Oxford University Press; 2018.
    1. Ritchie M, Dollar K, Miller C, Oliver K, Smith J, Lindsay J, et al. Using implementation facilitation to improve care in the Veterans Health Administration (version 2) Veterans Health Administration, Quality Enhancement Research Initiative (QUERI) for Team-Based Behavioral Health; 2017.
    1. Neumann PJ, Sanders GD, Russell LB, Siegel JE, Ganiats TG. Cost-effectiveness in health and medicine. Oxford University Press; 2016. p. 537.
    1. Drummond M, Coyle D. The role of pilot studies in the economic evaluation of health technologies. Int J Technol Assess Health Care. 1998;14(3):405–418. doi: 10.1017/S0266462300011399.
    1. Crespi CM. Improved designs for cluster randomized trials. Annu Rev Public Health. 2016;37(1):1–16. doi: 10.1146/annurev-publhealth-032315-021702.
    1. Brener N, Kann L, Shanklin S, Kinchen S, Eaton D, Hawkins J, et al. Methodology of the youth risk behavior surveillance system--2013. MMWR Recomm Rep. 2013;62(RR-1):1–20.
    1. Morse JMR. Approaches to qualitative-quantitative methodological triangulation. Nurs Res. 1991;40(2):120–123. doi: 10.1097/00006199-199103000-00014.
    1. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. doi: 10.1186/s13012-017-0635-3.
    1. Creswell J, Plano Clark V. Designing and conducting mixed methods research. 3. Los Angeles: SAGE; 2018. p. 492.
    1. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–1288. doi: 10.1177/1049732305276687.
    1. Miles MB, Huberman AM, Saldaña J. Qualitative data analysis: a methods sourcebook. 3. Thousand Oaks: SAGE Publications, Inc; 2014. p. 381.
    1. Corbin JM, Strauss AL, Strauss AL. Basics of qualitative research: techniques and procedures for developing grounded theory. 1. 1998. p. 312.
    1. Boyatzis RE. Transforming qualitative information: thematic analysis and code development. Thousand Oaks: Sage Publications; 1998. p. 184.
    1. Saldana L. The stages of implementation completion for evidence-based practice: protocol for a mixed methods study. Implement Sci. 2014;9(1):43. doi: 10.1186/1748-5908-9-43.
    1. Bowser D, Henry B, McCollister K. Cost analysis in implementation studies of evidence-based practices for mental health and substance use disorders: a systematic review. Implement Sci. 2021;16(26):15.
    1. Holmes L, Landsverk J, Ward H, Rolls-Reutz J, Saldana K, Wulczyn F, et al. Cost calculator methods for estimating casework time in child welfare services: a promising approach for use in implementation of evidence-based practices and other service innovations. Child Youth Serv Rev. 2014;39:169–176. doi: 10.1016/j.childyouth.2013.10.003.
    1. Chamberlain P, Snowden L, Padgett C, Saldana L, Roles J, Holmes L, et al. A strategy for assessing costs of implementing new practices in the child welfare system: adapting the english cost calculator in the United States. Adm Policy Ment Health. 2011;38(1):24–31. doi: 10.1007/s10488-010-0318-8.
    1. Eisman A, Hutton D, Prosser L, Smith S, Kilbourne A. Cost-effectiveness of the Adaptive Implementation of Effective Programs Trial (ADEPT): approaches to adopting implementation strategies. Implement Sci. 2020;15(1):1–13. doi: 10.1186/s13012-020-01069-w.
    1. EuroQol Research Foundation. EQ-5D-5L User Guide, 2019. Available from: .
    1. Barrera M, Berkel C, Castro FG. Directions for the advancement of culturally adapted preventive interventions: local adaptations, engagement, and sustainability. Prev Sci. 2017;18(6):640–648. doi: 10.1007/s11121-016-0705-9.
    1. Johnston LD, Miech RA, O’Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the future national survey results on drug use: 1975-2017. Ann Arbor: Institute for Social Research; 2018. p. 126.
    1. 2018 National Survey on Drug Use and Health (NSDUH): CAI Specifications for Programming. Rockville, MD: Center for Behavioral Health Statistics and Quality; 2017.
    1. Giles SM, Harrington NG, Fearnow-Kenney M. Evaluation of the All Stars Program: Student and Teacher Factors That Influence Mediators of Substance Use. J Drug Educ. 2001;31(4):385–97.
    1. Home | Michigan Model for Health [Internet]. Available from: . Cited 14 Dec 2020.
    1. Stirman S, Miller C, Toder K, Calloway A. Development of a framework and coding system for modifications and adaptations of evidence-based interventions. Implement Sci. 2013;8(1):65. doi: 10.1186/1748-5908-8-65.
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10(1):10. doi: 10.1186/1471-2288-10-1.
    1. Sim J. Should treatment effects be estimated in pilot and feasibility studies? Pilot Feasibility Stud. 2019;5(1):1–7. doi: 10.1186/s40814-019-0493-7.
    1. West BT, Welch KB, Galecki AT. Linear Mixed Models: A Practical Guide Using Statistical Software. 2nd ed. Chapman and Hall/CRC; 2014. [cited 2020 Feb 28].
    1. Miller T, Hendrie D. Substance abuse prevention dollars and cents: a cost-benefit analysis. Rockville: Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration; 2008.

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