1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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)

31. 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)

32. 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

33. 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

34. 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