Substance AbuseNCT06856148
Testing Strategies to Improve Substance Misuse Prevention Research Use in State Policy Contexts
A study testing Intervention: RPC Group in people with Substance Abuse and Substance Use Disorders, run by Penn State University at 1 site in United States.
Trial summary
If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Substance Use Disorders, Prevention
- What is being tested?
- Intervention: RPC Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- State-level public officials
Who cannot join
- Anyone who is not a state-level public official
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State University
University Park, Pennsylvania, 16802
D. Max Crowley, Ph.D., 1-866-905-1872, dmc397@psu.edu
J. Taylor Scott, Ph.D., 864-431-2411, jxs1622@psu.edu
About this study
Official title: Building the Science of Evidence-Informed Prevention Policy: a Multi-level Model for Supporting Substance Misuse Prevention
If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Accordingly, a state-level randomized controlled trial (N = 30 states) of a formal, theory-based approach for appropriately supporting policymakers' use of scientific evidence--known as the Research-to-Policy Collaboration (RPC) Model is proposed. This work has the potential to reduce population-level substance misuse by improving the use of scientific information in policymaking, thus increasing the availability of evidence-based prevention programs and policies.
Read the detailed description
If science is to inform policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence. However, the field lacks an evidence-based model designed for supporting state policymakers' use of prevention research in crafting legislation. Instead, the field continues to largely rely on ad hoc strategies for translating prevention research (e.g., opportunistic outreach and responding to policymakers' requests if or when they are made). Accordingly, an experimental study of a formal, theory-based approach for supporting policymakers' use of scientific evidence that does not involve lobbying-the Research-to-Policy Collaboration (RPC) Model is proposed. The RPC fosters productive engagement between the policy and research communities by implementing systematic capacity building and outreach strategies. Previous experimental work on the RPC demonstrated the ability of this model to increase engagement between researchers and policymakers, increase policymakers' value for research evidence, and improve their use of scientific evidence in their policymaking.1 The study proposes a state-level randomized controlled trial of the RPC (N = 30 state legislatures) that will evaluate the model's ability to improve engagement between state policymakers' and the prevention science community, build policymakers' awareness and value of substance misuse prevention research, and subsequently their use of research evidence throughout the policymaking process. To accomplish this, the study will test three specific research aims. Aim 1 will assess historical and current use of research evidence in state legislation pertaining to substance misuse prevention. This will involve qualitative coding of bills introduced by state legislatures over the last five years. Aim 2 will compare the frequency and quality of engagement with prevention researchers between the intervention and control conditions. Additionally, the study will assess how the RPC model influences policymakers' value and awareness of substance misuse prevention over time using a validated survey across three time points. Aim 3 will evaluate the effectiveness of the RPC on legislators' actual use of research in legislation by observing and quantifying changes in legislator behavior related to research use. Improving the use of scientific information in policymaking can reduce population-level substance misuse by increasing the availability of evidence-based prevention programs and policies.
- Conditions
- Substance Abuse, Substance Use Disorders, Prevention, Legislation, Use of Research Evidence
- Being tested
- Intervention: RPC Group, Active Comparator: Control Group
- Keywords
- Randomized Control Trial, Substance Abuse Prevention, Substance Misuse Prevention, Prevention Policy, Evidence-Based Policy, Policymaking, Research Communications, Research Translation, Public Policy, Public Health
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: RPC GroupBehavioural
The RPC model entails seven interrelated steps including a capacity building and collaboration phase. Throughout the implementation, researchers are provided direct access to intermediary support from our trained RPC fellows who facilitate RPC activity at each step coordinated by an implementation supervisor. Importantly, this model does not involve any lobbying. Consistent with NIH guidelines for grantees, the RPC instead aims to "highlight and translate public health evidence…; conduct coalition building…; provide leadership and training, and foster safe and healthful environments". Specifically, implementation of the RPC model explicitly does not attempt to influence legislative actions, but instead facilitates honest brokerage in which researchers discuss evidence without indicating opinion or stance on how legislators should change specific policies, programs, or regulations.
Active Comparator: Control GroupBehavioural
Control group participants will receive "light touch" research support, similar to previous work (e.g., an RPC associate will send publicly available research materials in response to research requests). This light touch control condition will increase responsiveness of state officials to survey follow up requests.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Legislative offices who receive the full Research-to-Policy Model intervention. Receives: Behavioral: Intervention: RPC Group |
| Control Group | Active comparator | Legislative Offices who do not receive the full RPC Model intervention. Receives: Behavioral: Active Comparator: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
RPC impact on introduction of evidence-informed bills
Assessment of use of research evidence in bills introduced during the intervention period. It is anticipated that legislators will introduce over 5,000 bills relating to substance use are. These bills will be coded for presence of evidence markers using a validated, deductive codebook to identify how legislators use research evidence in legislative language. A subset of these bills (N = 150) will be reviewed by trained coders to identify the form (i.e. direct or indirect) and the goal of evidence use (i.e., sharing the cause of the problem, status of the problem, solving the problem, generating new knowledge, or accountability). Observed use of research evidence in bills will be quantified and analyzed in a series of multi-level models to test change across three time points.
Measured: Baseline, post intervention, and 6-months post intervention
Secondary outcomes (4)
RPC impact on legislators' perceived use of prevention research
Legislators' perceived use of research evidence will be assessed with the Reported Use of Research Evidence Scale (minimum value = 1, maximum value =5, higher scores indicate increased use of research evidence), which assesses use of research across various stages of the policy process (e.g., agenda setting, policy evaluation) and the three types of research use (i.e., instrumental, conceptual, and symbolic). Research will be defined for participants as information gleaned from scientific studies, academic investigations, or program evaluations assessing the effectiveness of an intervention. Surveys from state legislators will be analyzed longitudinally by modeling change across the two time points-including multi-level repeated measures and growth curve models (MLM).
Measured: Baseline, post intervention, and 6 months post-intervention
RPC impact on legislators' engagement with prevention researchers
The investigators will use validated quantitative survey instrument to investigate how the RPC model influences the frequency of policymakers' different types of interactions with researchers (5-pt. Likert scale; ɑ = .89). A series of multi-level models will be employed to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following the intervention. Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects. Survey data from state legislators will also be analyzed longitudinally across the three time points-including multi-level repeated measures and growth curve models (MLM) using MPlus.
Measured: Baseline, post collaboration, and 6 months post-intervention
RPC impact on state legislators' value of substance misuse prevention science
The investigators will use a validated quantitative survey instrument to assess how the RPC model influences legislators' perceived value of research use in their work and in policymaking more generally. It will be measured with an adapted version of the Seeking, Engaging with, and Evaluating Research (SEER) protocol. Policymakers will be asked to rate how strongly they agree with four statements assessing whether they feel they know general information pertaining to prevention programming. A series of multi-level models will be employed to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following intervention). Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects.
Measured: Baseline, post intervention, and 6 months post intervention
RPC effectiveness on legislators' awareness of substance misuse prevention science
The investigators will use a validated quantitative survey instrument to investigate how the RPC model influences legislators' awareness of substance misuse prevention science. Policymakers will be asked to rate how strongly they agree with four statements assessing whether they feel they know general information pertaining to prevention programming. A series of multi-level models will be used to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following intervention). Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects.
Measured: Baseline, post intervention, and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sampled states' legislatures will be randomly assigned to either a comprehensive intervention or a control group that receives minimal intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Daniel Max Crowley, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856148
- Sponsor's protocol ID
- STUDY00021641
- Other IDs
- R01DA056627
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building the Science of Evidence-Informed Prevention Policy: a Multi-level Model for Supporting Substance Misuse Prevention
- ClinicalTrials.gov ID
- NCT06856148
- Acronym / sponsor ID
- STUDY00021641
- Conditions
- Substance Abuse, Substance Use Disorders, Prevention, Legislation, Use of Research Evidence
- Keywords
- Randomized Control Trial, Substance Abuse Prevention, Substance Misuse Prevention, Prevention Policy, Evidence-Based Policy, Policymaking, Research Communications, Research Translation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Accordingly, a state-level randomized controlled trial (N = 30 states) of a formal, theory-based approach for appropriately supporting policymakers' use of scientific evidence--known as the Research-to-Policy Collaboration (RPC) Model is proposed. This work has the potential to reduce population-level substance misuse by improving the use of scientific information in policymaking, thus increasing the availability of evidence-based prevention programs and policies.
Detailed description
If science is to inform policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence. However, the field lacks an evidence-based model designed for supporting state policymakers' use of prevention research in crafting legislation. Instead, the field continues to largely rely on ad hoc strategies for translating prevention research (e.g., opportunistic outreach and responding to policymakers' requests if or when they are made). Accordingly, an experimental study of a formal, theory-based approach for supporting policymakers' use of scientific evidence that does not involve lobbying-the Research-to-Policy Collaboration (RPC) Model is proposed. The RPC fosters productive engagement between the policy and research communities by implementing systematic capacity building and outreach strategies. Previous experimental work on the RPC demonstrated the ability of this model to increase engagement between researchers and policymakers, increase policymakers' value for research evidence, and improve their use of scientific evidence in their policymaking.1 The study proposes a state-level randomized controlled trial of the RPC (N = 30 state legislatures) that will evaluate the model's ability to improve engagement between state policymakers' and the prevention science community, build policymakers' awareness and value of substance misuse prevention research, and subsequently their use of research evidence throughout the policymaking process. To accomplish this, the study will test three specific research aims. Aim 1 will assess historical and current use of research evidence in state legislation pertaining to substance misuse prevention. This will involve qualitative coding of bills introduced by state legislatures over the last five years. Aim 2 will compare the frequency and quality of engagement with prevention researchers between the intervention and control conditions. Additionally, the study will assess how the RPC model influences policymakers' value and awareness of substance misuse prevention over time using a validated survey across three time points. Aim 3 will evaluate the effectiveness of the RPC on legislators' actual use of research in legislation by observing and quantifying changes in legislator behavior related to research use. Improving the use of scientific information in policymaking can reduce population-level substance misuse by increasing the availability of evidence-based prevention programs and policies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Sampled states' legislatures will be randomly assigned to either a comprehensive intervention or a control group that receives minimal intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention: RPC GroupLegislative offices who receive the full Research-to-Policy Model intervention. |
| Control Group | Active comparator | Behavioral: Active Comparator: Control GroupLegislative Offices who do not receive the full RPC Model intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- State-level public officials
Key exclusion criteria (1 listed)
- Anyone who is not a state-level public official
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: RPC GroupThe RPC model entails seven interrelated steps including a capacity building and collaboration phase. Throughout the implementation, researchers are provided direct access to intermediary support from our trained RPC fellows who facilitate RPC activity at each step coordinated by an implementation supervisor. Importantly, this model does not involve any lobbying. Consistent with NIH guidelines for grantees, the RPC instead aims to "highlight and translate public health evidence…; conduct coalition building…; provide leadership and training, and foster safe and healthful environments". Specifically, implementation of the RPC model explicitly does not attempt to influence legislative actions, but instead facilitates honest brokerage in which researchers discuss evidence without indicating opinion or stance on how legislators should change specific policies, programs, or regulations. | Behavioural | Intervention Group |
| Active Comparator: Control GroupControl group participants will receive "light touch" research support, similar to previous work (e.g., an RPC associate will send publicly available research materials in response to research requests). This light touch control condition will increase responsiveness of state officials to survey follow up requests. | Behavioural | Control Group |
Primary outcome
RPC impact on introduction of evidence-informed bills
Time frame: Baseline, post intervention, and 6-months post intervention
Assessment of use of research evidence in bills introduced during the intervention period. It is anticipated that legislators will introduce over 5,000 bills relating to substance use are. These bills will be coded for presence of evidence markers using a validated, deductive codebook to identify how legislators use research evidence in legislative language. A subset of these bills (N = 150) will be reviewed by trained coders to identify the form (i.e. direct or indirect) and the goal of evidence use (i.e., sharing the cause of the problem, status of the problem, solving the problem, generating new knowledge, or accountability). Observed use of research evidence in bills will be quantified and analyzed in a series of multi-level models to test change across three time points.
4 secondary outcomes
RPC impact on legislators' perceived use of prevention research
Time frame: Baseline, post intervention, and 6 months post-intervention
RPC impact on legislators' engagement with prevention researchers
Time frame: Baseline, post collaboration, and 6 months post-intervention
RPC impact on state legislators' value of substance misuse prevention science
Time frame: Baseline, post intervention, and 6 months post intervention
RPC effectiveness on legislators' awareness of substance misuse prevention science
Time frame: Baseline, post intervention, and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: RPC Group in people with Substance Abuse and Substance Use Disorders, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Crowley, Ph.D (866-905-1872, dmc397@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RPC impact on introduction of evidence-informed bills (time frame: Baseline, post intervention, and 6-months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.