Alcohol DrinkingNCT05380765
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
A study testing Native PATHS in people with Alcohol Drinking and Tobacco Use, run by University of Rhode Island at 1 site in United States.
Trial summary
The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Tobacco Use, Drug Use
- What is being tested?
- Native PATHS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- residing in the First Nation community,
- identify as a member of a First Nation,
- be in grades 5th - 8th at time of enrollment, and
- one youth per household may participate.
- at least 18 years of age
- reside within the First Nation community
- be identified, by the youth, as an important influence in their life
- be committed to helping the youth make good decisions regarding using substances
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Rhode Island
Kingston, Rhode Island, 02881-1967
Nichea S Spillane, Ph.D., 401-874-4252, nspillane@uri.edu
About this study
The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. First, the investigators will recruit youth who are in 5th - 8th grade and their family members (N=24, 12 youth, 12 adults 18+) to participate in three talking circle sessions to obtain feedback on the cultural adaptation and implementation of the treatment. Next, the investigators will conduct an open label pilot (N=9). Youth and their family members, (up to 3 per youth) will provide qualitative and quantitative feedback after each session. In Stage 1b, 60 youth will participate in a pilot randomized controlled trial, testing the efficacy of the newly created program (n=30) against a wait list control (WLC) condition (n=30). Ultimately, this program of research is expected to result in a well-specified, efficacious prevention program that could be readily disseminated and generalizable to other Indigenous populations with minimal adaptation.
Read the detailed description
Alcohol is one of the primary determinants of health disparity among many Indigenous populations with rates of alcohol-attributable mortality substantially higher than for Whites (73.8 per 100,000 vs. 27.5), and therefore, is a key threat to optimal health and well-being to Indigenous youth. Indigenous youth living in both the US and Canada tend to begin using alcohol, tobacco, and other drugs (ATOD) at earlier ages than most other ethnic/racial groups, and tend to move more quickly to regular use, resulting in earlier onset of ATOD disorders. Despite the severity of the problem, there continues to be an urgent unmet need for effective prevention programs that are culturally tailored to Indigenous populations of the US and Canada. The overall objective of this project is to develop and obtain preliminary data on the acceptability, feasibility, and initial efficacy of Native PATHS (Positive Approaches to reducing Harm from Substance Use). Native PATHS is a strengths-based, family prevention program for Indigenous youth in 5th-8th grade which focuses on delayed ATOD initiation. The development of Native PATHS has been guided by formative work in this community, taking a behavioral economic and positive psychological approach to prevention. Applied to prevention, behavioral economic theory focuses on reducing the availability of ATOD and increasing ATOD-free alternatives and the reinforcement received from engaging in ATOD-free activities. Activities in Native PATHS will work with families to help with establishing ATOD-free rules, limit physical availability of ATOD in the home, and reinforce youths' participation in ATOD-free activities. Positive psychological interventions (PPIs) focus on increasing positive emotions, life satisfaction, and well-being. PPIs will be used to enhance the enjoyment received from ATOD-free activities and to improve life satisfaction. Native PATHS is culturally consistent with North American Indigenous views of health that describe health in terms of a balance between the physical, spiritual, emotional, and mental aspects of life, which is represented in the teachings of the Medicine Wheel. Collaboratively, the investigators will work together with tribal partners on further adaptation of the program to include family and Indigenous ways of parenting in a culturally meaningful way. The overall goals proposed project will 1) finalize Native PATHS with participation from youth and family members in talking circles and an open pilot trial; 2) assess the effectiveness of Native PATHS in reducing ATOD initiation and intentions to use ATOD; 3) begin to evaluate the possible mechanisms/moderators of action including potential mediators future orientation and alternative reinforcer/activity engagement and reinforcement received, compared to a wait-list control group. The investigators will also evaluate positive affect as a potential moderator of any treatment effect, such that those higher in positive affect will be less likely to engage in ATOD use and be less likely to endorse intentions to use ATOD.
- Conditions
- Alcohol Drinking, Tobacco Use, Drug Use
- Being tested
- Native PATHS
- Medical subject headings
- Alcohol Drinking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native PATHSBehavioural
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
| Study group | Role | What they receive |
|---|---|---|
| Native PATHS Condition | Experimental | A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities. Receives: Behavioral: Native PATHS |
| Wait-List Control | No intervention | Participants will receive the Native PATHS program once 6-month follow up surveys have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Measured: Baseline
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past month alcohol use
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Measured: Six months following end of treatment
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Measured: Baseline
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past three-month alcohol use
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Measured: Six months following end of treatment
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Measured: Baseline
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past month marijuana use
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Measured: Six months following end of treatment
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Measured: Baseline
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past three-month marijuana use
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Measured: Six months following end of treatment
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Measured: Baseline
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Measured: Six months following end of treatment
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Measured: Baseline
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Measured: End of treatment (up to 12 weeks following baseline)
Past three-month cigarette smoking
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Measured: Six months following end of treatment
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Measured: Baseline
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Measured: End of treatment (up to 12 weeks following baseline)
Alcohol use intentions
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Measured: Six months following end of treatment
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Measured: Baseline
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Measured: End of treatment (up to 12 weeks following baseline)
Cigarette smoking susceptibility
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Measured: Six months following end of treatment
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Measured: Baseline
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Measured: End of treatment (up to 12 weeks following baseline)
Marijuana use intentions
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Measured: Six months following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Jun 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- wait-list control
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nichea S Spillane, Ph.D., Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380765
- Sponsor's protocol ID
- R34AA027619
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
- ClinicalTrials.gov ID
- NCT05380765
- Acronym / sponsor ID
- R34AA027619
- Conditions
- Alcohol Drinking, Tobacco Use, Drug Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 May 2022 (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.
The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. First, the investigators will recruit youth who are in 5th - 8th grade and their family members (N=24, 12 youth, 12 adults 18+) to participate in three talking circle sessions to obtain feedback on the cultural adaptation and implementation of the treatment. Next, the investigators will conduct an open label pilot (N=9). Youth and their family members, (up to 3 per youth) will provide qualitative and quantitative feedback after each session. In Stage 1b, 60 youth will participate in a pilot randomized controlled trial, testing the efficacy of the newly created program (n=30) against a wait list control (WLC) condition (n=30). Ultimately, this program of research is expected to result in a well-specified, efficacious prevention program that could be readily disseminated and generalizable to other Indigenous populations with minimal adaptation.
Detailed description
Alcohol is one of the primary determinants of health disparity among many Indigenous populations with rates of alcohol-attributable mortality substantially higher than for Whites (73.8 per 100,000 vs. 27.5), and therefore, is a key threat to optimal health and well-being to Indigenous youth. Indigenous youth living in both the US and Canada tend to begin using alcohol, tobacco, and other drugs (ATOD) at earlier ages than most other ethnic/racial groups, and tend to move more quickly to regular use, resulting in earlier onset of ATOD disorders. Despite the severity of the problem, there continues to be an urgent unmet need for effective prevention programs that are culturally tailored to Indigenous populations of the US and Canada. The overall objective of this project is to develop and obtain preliminary data on the acceptability, feasibility, and initial efficacy of Native PATHS (Positive Approaches to reducing Harm from Substance Use). Native PATHS is a strengths-based, family prevention program for Indigenous youth in 5th-8th grade which focuses on delayed ATOD initiation. The development of Native PATHS has been guided by formative work in this community, taking a behavioral economic and positive psychological approach to prevention. Applied to prevention, behavioral economic theory focuses on reducing the availability of ATOD and increasing ATOD-free alternatives and the reinforcement received from engaging in ATOD-free activities. Activities in Native PATHS will work with families to help with establishing ATOD-free rules, limit physical availability of ATOD in the home, and reinforce youths' participation in ATOD-free activities. Positive psychological interventions (PPIs) focus on increasing positive emotions, life satisfaction, and well-being. PPIs will be used to enhance the enjoyment received from ATOD-free activities and to improve life satisfaction. Native PATHS is culturally consistent with North American Indigenous views of health that describe health in terms of a balance between the physical, spiritual, emotional, and mental aspects of life, which is represented in the teachings of the Medicine Wheel. Collaboratively, the investigators will work together with tribal partners on further adaptation of the program to include family and Indigenous ways of parenting in a culturally meaningful way. The overall goals proposed project will 1) finalize Native PATHS with participation from youth and family members in talking circles and an open pilot trial; 2) assess the effectiveness of Native PATHS in reducing ATOD initiation and intentions to use ATOD; 3) begin to evaluate the possible mechanisms/moderators of action including potential mediators future orientation and alternative reinforcer/activity engagement and reinforcement received, compared to a wait-list control group. The investigators will also evaluate positive affect as a potential moderator of any treatment effect, such that those higher in positive affect will be less likely to engage in ATOD use and be less likely to endorse intentions to use ATOD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- wait-list control
| Arm | Type | Receives |
|---|---|---|
| Native PATHS Condition | Experimental | Behavioral: Native PATHSA strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities. |
| Wait-List Control | No intervention | –Participants will receive the Native PATHS program once 6-month follow up surveys have been completed. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- residing in the First Nation community,
- identify as a member of a First Nation,
- be in grades 5th - 8th at time of enrollment, and
- one youth per household may participate.
- at least 18 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Native PATHSA strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities. | Behavioural | Native PATHS Condition |
Primary outcome
Past month alcohol use
Time frame: Baseline
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past month alcohol use
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past month alcohol use
Time frame: Six months following end of treatment
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Past three-month alcohol use
Time frame: Baseline
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past three-month alcohol use
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past three-month alcohol use
Time frame: Six months following end of treatment
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Past month marijuana use
Time frame: Baseline
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past month marijuana use
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past month marijuana use
Time frame: Six months following end of treatment
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Past three-month marijuana use
Time frame: Baseline
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past three-month marijuana use
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past three-month marijuana use
Time frame: Six months following end of treatment
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Past month cigarette smoking
Time frame: Baseline
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past month cigarette smoking
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past month cigarette smoking
Time frame: Six months following end of treatment
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Past three-month cigarette smoking
Time frame: Baseline
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Past three-month cigarette smoking
Time frame: End of treatment (up to 12 weeks following baseline)
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Past three-month cigarette smoking
Time frame: Six months following end of treatment
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Alcohol use intentions
Time frame: Baseline
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Alcohol use intentions
Time frame: End of treatment (up to 12 weeks following baseline)
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Alcohol use intentions
Time frame: Six months following end of treatment
Respondent will be asked how often in the next month they think they will get drunk with friends and how often in the next month they would like to get drunk with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use alcohol in the next month.
Cigarette smoking susceptibility
Time frame: Baseline
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Cigarette smoking susceptibility
Time frame: End of treatment (up to 12 weeks following baseline)
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Cigarette smoking susceptibility
Time frame: Six months following end of treatment
Cigarette smoking intentions will be measured using the Susceptibility to Smoking measure, which includes four items that asking respondents the likelihood that they will begin to smoke/experiment with cigarettes on a four-point scale from 0 (definitely not) to 3 (definitely yes), with higher scores indicating greater likelihood of intending to smoke cigarettes in the future.
Marijuana use intentions
Time frame: Baseline
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Marijuana use intentions
Time frame: End of treatment (up to 12 weeks following baseline)
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Marijuana use intentions
Time frame: Six months following end of treatment
Respondent will be asked how often in the next month they think they will use marijuana with friends and how often in the next month they would like to use marijuana with friends, on a five-point scale from 0 (never) to 4 (10 or more times), where higher scores indicate more frequent intentions to use marijuana in the next month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Alcohol Drinking
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
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. This study is not recruiting at the moment.
Nichea S Spillane, Ph.D. principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native PATHS in people with Alcohol Drinking and Tobacco Use, run by University of Rhode Island 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nichea S Spillane, Ph.D. ((401) 874-4252, nspillane@uri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past month alcohol use (time frame: Baseline). The study lists 27 primary outcomes in all. 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 5 Jun 2024.