for PrincipleDriven Behavioral Intervention Development Lisa Onken PhD RCCN Meeting National Institute on Aging December 11 2018 Understanding mechanisms is essential Not simply to maximize potency ID: 908385
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Slide1
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
Slide2Understanding 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.
The importance of principle-driven intervention development
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide3An 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
Slide4An 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
Slide5An 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
Slide6Has 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
Slide7Many 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
Slide8An abundance of efficacious interventions…
H
Q
BMP
N
C
F
E
K
A
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O
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I
J
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide9Could some be operating under the same principle(s)
H
Q
BMP
N
C
F
E
K
A
L
O
D
G
I
J
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide10Could some be operating under the same principle(s)
H
Q
BMP
N
C
F
E
K
A
L
O
D
G
I
J
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide11Could some be operating under the same principle(s)
H
Q
BMP
N
C
F
E
K
A
L
O
D
G
I
J
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide12Principle Y
Principle X
Principle Z
A limited number of principles
?
?
?
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide13A limited number of principles: Helps choice
Understanding mechanism can help determine:
What interventions are operating via the same
principlesWhat interventions are operating via different principles.
?
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide14Understanding 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 interventionSimplify the intervention*Reduce implementation cost*Improve ability to train* ↓ Improved Scalability*While maximizing potencyLisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide15The NIH Stage Model Goal
Maximally Implementable & Maximally Efficacious Principle-Driven
InterventionsLisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide16NIH Stage Model Characteristics
Non-Prescriptive!
Non-Linear
Iterative, Recursive Full Range of Translational Research is Addressed Principles (mechanisms) of behavior change: CriticalLisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide17x
x
x
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide18Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide19Stage 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
Slide20Stage I: Intervention Creation & Refinement
STAGE I
Stage 0
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
Slide21Stage I: Intervention Creation & Refinement
STAGE I
Stage 0
Basic Research
Stage I: Research setting
Community setting
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide22Stage I: Intervention Creation & Refinement
STAGE I
Stage 0
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
Slide23Stage I work is INCOMPLETE until…
Intervention is maximally potent + efficacious
Intervention is maximally implementable
Fidelity of delivery is maximally addressedTraining methods are fully developedIntervention is maximally streamlinedLisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide24Stage II: Efficacy Testing
Stage I
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
Slide25Stage II: Efficacy Testing With High Internal Validity
Stage I
Generation/ Refinement/
Training/ Fidelity
Stage 0
Basic research
STAGE II: Efficacy
High Internal Validity
Research Providers +
Research Settings
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide26Stage III: Efficacy Testing
Stage I
Intervention Generation/ Refinement
Stage II
Efficacy (Research clinics)
Stage III
Efficacy Testing
Stage 0
Basic research
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide27Stage III: High Internal Validity RCT
Stage I
Intervention Generation/ Refinement
Stage II
Efficacy (Research clinics)
Stage III
High Internal Validity
:
Community Therapists Community Settings
Stage 0
Basic research
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide28Stage II usually does not lead to Stage III
Stage I
Intervention Generation/ Refinement
Stage II
Efficacy (Research clinics)
Stage III
Efficacy Testing:
Community Providers Community Settings
Stage 0
Basic research
X
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide29Why 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
Slide30Stage IV: EFFECTIVENESS & PRAGMATIC CLINICAL TRIALS
Stage I
Intervention Generation/ Refinement
Stage II
Efficacy (Research providers)
Stage IV
Effectiveness Testing:
Pragmatic Clinical Trials
Stage 0
Basic research
Stage III
Efficacy (Community providers)
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide31Stage IV: High EXTERNAL Validity RCT
Stage I
Intervention Generation/ Refinement
Stage II
Efficacy (Research providers)
Stage IV
Effectiveness Testing:
Pragmatic Clinical Trials
Community Providers Community Settings
Stage 0
Basic research
Stage III
Efficacy (Community providers)
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide32NIH Stage Model
Stage I
Intervention generation/ refinement
Stage IIEfficacy (Research Providers)
Stage III
Efficacy (Community Providers)
Stage 0
Basic research
x
x
x
x
Stage V
Implementation & Dissemination
x
x
x
Stage IV
Effectiveness
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018
Slide33Paths will vary:
Stage I may be the best step following Stage II, III, or IV
:
Produce training materialsProduce methods to ensure fidelityOtherwise ↑ implementabilityStage I may lead directly to Stage III or Stage IV↑ implementability ↑ the probability of success in Stage III & Stage IVStage 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
Slide34Thank You!
Stage I
Intervention generation/ refinement
Stage IIEfficacy (Research Providers)
Stage III
Efficacy (Community Providers)
Stage 0
Basic research
x
x
x
x
Stage V
Implementation & Dissemination
x
x
x
Stage IV
Effectiveness
Lisa Onken, "Achieving and Sustaining Behavior Change to Benefit Older Adults" Dec 6-7, 2018