Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents

June 4, 2024 updated by: University of Rhode Island
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nichea S Spillane, Ph.D.
  • Phone Number: (401) 874-4252
  • Email: nspillane@uri.edu

Study Locations

  • United States
    • Rhode Island
      • Kingston, Rhode Island, United States, 02881-1967
        • Recruiting
        • University of Rhode Island
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria - Youth Participants:

  1. residing in the First Nation community,
  2. identify as a member of a First Nation,
  3. be in grades 5th - 8th at time of enrollment, and
  4. one youth per household may participate.

Inclusion Criteria - Family Participants:

  1. at least 18 years of age
  2. reside within the First Nation community
  3. be identified, by the youth, as an important influence in their life
  4. be committed to helping the youth make good decisions regarding using substances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Native PATHS Condition
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
Behavioral: Native PATHS
A strengths-based, behavioral economic approach to increasing engagement and reinforcement for engaging in alternative activities.
No Intervention: Wait-List Control
Participants will receive the Native PATHS program once 6-month follow up surveys have been completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Past month alcohol use
Time Frame: Baseline
Respondents will be asked whether they have used alcohol in the past month (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
Past three-month alcohol use
Time Frame: Baseline
Respondents will be asked whether they have used alcohol in the past three months (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
Past month marijuana use
Time Frame: Baseline
Respondents will be asked whether they have used marijuana in the past month (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
Past three-month marijuana use
Time Frame: Baseline
Respondents will be asked whether they have used marijuana in the past three months (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
Past month cigarette smoking
Time Frame: Baseline
Respondents will be asked whether they have smoked cigarettes in the past month (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
Past three-month cigarette smoking
Time Frame: Baseline
Respondents will be asked whether they have smoked cigarettes in the past three months (yes/no).
Baseline
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).
End of treatment (up to 12 weeks following baseline)
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).
Six months following end of treatment
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.
Baseline
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.
End of treatment (up to 12 weeks following baseline)
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.
Six months following end of treatment
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.
Baseline
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.
End of treatment (up to 12 weeks following baseline)
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.
Six months following end of treatment
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.
Baseline
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.
End of treatment (up to 12 weeks following baseline)
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.
Six months following end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rhode Island

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nichea S Spillane, Ph.D., University of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AA027619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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