National Institute on Aging NIH Stage Model: A Translational Framework for Principle-Driven Behavioral Intervention Development Lisa Onken, Ph.D. RCCN Meeting National Institute on Aging December 11, 2018

The importance of principle-driven intervention development Understanding mechanisms is essential. Not simply to maximize potency: Also to understand intervention principles, how to personalize, when and when not to generalize, and to generally improve ease of implementation. Both neuroscience & technology can play critical roles in understanding mechanisms, and can help, ultimately, to improve implementability. Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

An Abundance of Riches “By the turn of this century, Kazdin (2000) identified 551 different named therapies used with children and adolescents … Identifying ESTs is now a growth industry: The National Registry of Evidence-Based Programs and Practices … lists 306 “evidence-based” interventions, 192 for children and adolescents.” (Weisz, 2014). Identifying ESTs is now a growth industry: The National Registry of Evidence-Based Programs and Practices … lists 306 “evidence-based” interventions, 192 f “ Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States.” (Gitlin et al., 2015) or children and adolescents.” (Weisz, 2014). “Psychological interventions to treat mental health issues have developed remarkably in the past few decades. (Kazdin & Blase, 2011)” “… this progress often neglects a central goal—namely, to reduce the burden of mental illness and related conditions.” (Kazdin & Blase, 2011) Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States.” (Gitlin et al., 2015) Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

An Abundance of Riches “By the turn of this century, Kazdin (2000) identified 551 different named therapies used with children and adolescents … The National Registry of Evidence-Based Programs and Practices … lists 306 “evidence-based” interventions, 192 for children and adolescents.” (Weisz, 2014). “ Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States.” (Gitlin et al., 2015) or children and adolescents.” Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

An Abundance of Riches “By the turn of this century, Kazdin (2000) identified 551 different named therapies used with children and adolescents … The National Registry of Evidence-Based Programs and Practices … lists 306 “evidence-based” interventions, 192 for children and adolescents.” (Weisz, 2014). Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States.” (Gitlin et al., 2015) or children and adolescents.” (Weisz, 2014). Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Has this progress been enough? Mental Health Interventions “Psychological interventions to treat mental health issues have developed remarkably in the past few decades. (Kazdin & Blase, 2011)” “… this progress often neglects a central goal—namely, to reduce the burden of mental illness and related conditions.” (Kazdin & Blase, 2011) Over the past 3 decades, more than 200 dementia caregiver interventions have been tested in randomized clinical trials and found to be efficacious. Dementia Caregiver Interventions “Few programs have been translated for delivery in various service contexts, and they remain inaccessible to the 15+ million dementia family caregivers in the United States.” (Gitlin et al., 2015). States.” (Gitlin et al., 2015) Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Many efficacious interventions…but Few people in need receive them. They don’t work for everyone. They don’t always work well enough. They’re often delivered with questionable fidelity in the real-world. It can be difficult to choose among hundreds of efficacious interventions Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

An abundance of efficacious interventions… G D E F J L H K I N O M Q P Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Could some be operating under the same principle(s) F J L H K I N O M Q P Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Could some be operating under the same principle(s) F J L H K I N O M Q P Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Could some be operating under the same principle(s) F J L H K I N O M Q P Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

A limited number of principles Principle X Principle Y Principle Z ? ? ? Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

A limited number of principles: Helps choice Understanding mechanism can help determine: What interventions are operating via the same principles What interventions are operating via different principles. ? Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Understanding Mechanism (MOA)can help: Explicate Intervention Principles Know why it works well- or doesn’t Know how to make it work better --- and how to modify an intervention Simplify the intervention* Reduce implementation cost* Improve ability to train* ↓ Improved Scalability *While maximizing potency Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

The NIH Stage Model Goal Maximally Implementable & Maximally Efficacious Principle-Driven Interventions Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

NIH Stage Model Characteristics Non-Prescriptive! Non-Linear Iterative, Recursive Full Range of Translational Research is Addressed Principles (mechanisms) of behavior change: Critical Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Intervention Generation/ Refinement Stage I Intervention Generation/ Refinement Stage II Efficacy (Research Clinics) Stage III Efficacy (Community Clinics) Stage IV Effectiveness Stage V Implementation & Dissemination Stage 0 Basic research x x x Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage 0 may also follow later stages to help address mechanisms of behavior change. Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage I: Intervention Creation & Refinement Basic Research Stage I: Creation Adaptation Modification Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage I: Intervention Creation & Refinement Basic Research Stage I: Research setting Community setting Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage I: Intervention Creation & Refinement Basic Research Stage I: Develop Training Materials Develop Materials to Maximize Fidelity Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage I work is INCOMPLETE until… Intervention is maximally potent + efficacious Intervention is maximally implementable Fidelity of delivery is maximally addressed Training methods are fully developed Intervention is maximally streamlined Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage II: Efficacy Testing Generation/ Refinement/ Training/ Fidelity STAGE II: Efficacy Stage 0 Basic research Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage II: Efficacy Testing With High Internal Validity Generation/ Refinement/ Training/ Fidelity STAGE II: Efficacy High Internal Validity Research Providers + Research Settings Stage 0 Basic research Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage III: Efficacy Testing Intervention Generation/ Refinement Stage II Efficacy (Research clinics) Stage 0 Basic research Stage III Efficacy Testing Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage III: High Internal Validity RCT Intervention Generation/ Refinement Stage II Efficacy (Research clinics) Stage 0 Basic research Stage III High Internal Validity: Community Therapists Community Settings Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage II usually does not lead to Stage III Intervention Generation/ Refinement Stage II Efficacy (Research clinics) Stage 0 Basic research X Stage III Efficacy Testing: Community Providers Community Settings Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Training materials not available for community providers. Why Not? Training materials not available for community providers. Methods of maximizing fidelity of delivery in the community have not been developed. Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

Stage IV: EFFECTIVENESS & PRAGMATIC CLINICAL TRIALS Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Stage I Intervention Generation/ Refinement Stage 0 Basic research Stage II Efficacy (Research providers) Stage IV Effectiveness Testing: Pragmatic Clinical Trials Stage III Efficacy (Community providers)

Stage IV: High EXTERNAL Validity RCT Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Stage I Intervention Generation/ Refinement Stage 0 Basic research Stage II Efficacy (Research providers) Stage IV Effectiveness Testing: Pragmatic Clinical Trials Community Providers Community Settings Stage III Efficacy (Community providers)

x x x x x x x NIH Stage Model Stage I Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Stage I Intervention generation/ refinement Stage II Efficacy (Research Providers) Stage 0 Basic research x x x x Stage III Efficacy (Community Providers) Stage V Implementation & Dissemination x x x Stage IV Effectiveness

Paths will vary: Stage I may be the best step following Stage II, III, or IV: Produce training materials Produce methods to ensure fidelity Otherwise ↑ implementability Stage I may lead directly to Stage III or Stage IV ↑ implementability ↑ the probability of success in Stage III & Stage IV Stage III may be necessary for successful Stage IV: Sometimes success in Stage III is required to ↑ the probability of a successful effectiveness trial. Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018

x x x x x x x Thank You! Stage I Intervention generation/ refinement Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018 Stage I Intervention generation/ refinement Stage II Efficacy (Research Providers) Stage 0 Basic research x x x x Stage III Efficacy (Community Providers) Stage V Implementation & Dissemination x x x Stage IV Effectiveness