An interventional study of Native Spirit After-School Program in Substance Use, Self Esteem and Youth Drinking, sponsored by Arizona State University. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Arizona State University · Not applicable, Interventional, and Prevention
The proposed research will used community-based participatory research methods in an urban-based American Indian (AI) community to adapt, implement, and evaluate an after-school program, called Native Spirit (NS), that seeks to improve cultural identity, self-esteem, resilience, and prevent substance use by increasing cultural engagement. Prior research suggests that AI youth that are culturally engaged experience better health outcomes. Additionally, the use of culturally-specific after-school programs has been shown to increase feasibility and sustainability of prevention programs. In order to achieve the goals of this proposed study, the Principal Investigator (PI) will work with local community members and existing tribal partners to implement the 10-session culturally-grounded after-school program and evaluate the program with the following aims:
Specific Aim 3 (R00): Examine the effectiveness of NS (increases exposure to local cultural values and activities), a program that seeks to prevent or decrease substance use by strengthening self-esteem, resilience, and cultural identity with 2 Indigenous communities in Arizona using a wait-list control design with 3 data collection timepoints and participant interviews.
Specific Aim (SA) 3:
The objective of SA 3 is to examine the effectiveness of Native Spirit (NS) in the Salt River Pima Maricopa Indian Community (SRPMIC) and Pascua Yaqui Tribe (PYT) adolescents (grades 7-12) on preventing or decreasing substance use and strengthening cultural identity, self-esteem, and resilience. SA 3 will use a wait-list control design.
Procedure:
Step 1: Recruitment and Consent 1.1 Recruitment and consent process will occur December 2024-January 2025 for SRPMIC and July-September 2025 for PYT Cohort 1 and Jul7-September 2026 for PYT Cohort 2.
Step 2: Baseline Assessment - Time 1 (T1)
2.1 SRPMIC participants will take the T1 assessment in January 2025. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each others assessment answers to minimize confidentiality risks. PYT participants will take the T1 assessment in August 2025.
Who: Virtual surveys will be administered by the PI and research team. Where: T1 assessment will be completed at the research sites - the SRPMIC Way of Life Facility and the PYT Boys \& Girls Club.
How Long: T1 assessment will take 20-30 minutes to complete. How/What data: T1 assessment data will be collected virtually through REDCap. Duration: T1 assessment data will be completed in January 2025 for SRPMIC and August 2025 for PYT.
Step 3: Spring 2025 Intervention 3.1 SA3 uses a wait-list control design. The SRPMIC will be allocated to the intervention first. This is because the PI has worked with the SRPMIC for five years and the SRPMIC already has a developed intervention curriculum (the PI will submit a modification for review once curriculum is updated for 2025 intervention). This will allow the PI and the PYT to adapt the intervention. The intervention group (SRPMIC) will receive the intervention (NS program). Each intervention session is based on an Indigenous cultural value and cultural activity/practice that is specific to the SRPMIC.
Who: Intervention sessions will be facilitated by local cultural knowledge holders. At least one member of the research team will attend each session to ensure fidelity Where: Intervention sessions will be held at the research sites - the SRPMIC Way of Life Facility How Long: Each intervention session will last for 60-90 minutes, once a week for 10 weeks Duration: The Spring intervention will take place from January 2025 - May 2025
3.2 The research team will take candid pictures during the intervention that can be used for results dissemination. Any identifiable pictures with youth who do not have signed assent/consent forms will be immediately deleted.
Step 4: Follow-Up Assessment - Time 2 (T2) 4.1 SRPMIC participants will take the T2 assessment in May 2025. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each other's assessment answers to minimize confidentiality risks.
Who: Virtual surveys will be administered by the PI and research team. Where: T2 assessment will be completed at the research site - the SRPMIC Way of Life Facility How Long: T2 assessment will take 20-30 minutes to complete. How/What data: T2 assessment data will be collected virtually through REDCap. Duration: The T2 assessment will be completed in May 2025
Step 5: Spring Participant interviews
5.1 Participants who received the NS intervention in the Spring will be recruited to participate in the participant interviews based on their quantitative assessment scores. The research team will recruit participants who are interested in being interviewed. Each participant will complete an individual, 30-60-minute interview intended to identify personal impacts of participation in the NS program on self-esteem, resilience, cultural identity, and substance use. Interview questions are included in an attachment Who: Interviews will be conducted by the research assistants who have received training in interview procedures.
Where: Interviews will be held in private rooms at the research site - the SRPMIC Way of Life Facility How/What data: Interview data will be collected with a digital recorder. How Long: Each interview will last for 30-45 minutes Duration: Spring interviews will be completed between May-June 2025
Step 6: Fall 2025 Usual Programming
6.1 Both groups (SRPMIC and PYT) will receive control or "usual" programming. Usual programming includes a life skills program that focuses on financial wellness for teens, called "Money Matters" (Usual Practice). Participants will learn valuable financial life skills.
Who: Control sessions will be facilitated by the research site partner (after-school program employees) who typically implement their usual programming Where: Control sessions will be held at the research site - the SRPMIC Way of Life Facility and the PYT Boys \& Girls Clubs How Long: Each control session will last for 60-90 minutes, once a week for 10 weeks Duration: The Fall Usual Programming will take place from August 2025 - December 2025
Step 7: Follow-Up Assessment - Time 2 (T2) and Time 3 (T3)
7.1 SRPMIC participants will take the T3 assessment in December 2025 and PYT participants will take the T2 assessment also in December 2025. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each other's assessment answers to minimize confidentiality risks.
Who: Virtual surveys will be administered by the PI and research team. Where: T3 and T2 assessments will be completed at the research sites - the SRPMIC Way of Life Facility and the PYT Boys \& Girls Club How Long: T2 and T3 assessments will take 20-30 minutes to complete. How/What data: T2 and T3 assessment data will be collected virtually through REDCap.
Duration: The T2 and T3 assessments will be completed in December 2025
Step 8: Spring 2026 Intervention
8.1 The wait-list group (PYT Cohort 1) will receive the intervention (NS program). Each intervention session is based on an Indigenous cultural value and cultural activity/practice that is specific to the PYT. The PYT intervention curriculum will be developed between July 2025-December 2025. It will have a similar organizational structure.
Who: Intervention sessions will be facilitated by local cultural knowledge holders. At least one member of the research team will attend each session to ensure fidelity Where: Intervention sessions will be held at the research site - PYT Boys \& Girls Club How Long: Each intervention session will last for 60-90 minutes, once a week for 10 weeks Duration: The Spring 2026 Cohort 1 intervention will take place from January-March 2026.
8.2 The research team will take candid pictures during the intervention that can be used for results dissemination. Any identifiable pictures with youth who do not have signed assent/consent forms will be immediately deleted.
Step 9: Follow-Up Assessment - Time 3 (T3)
9.1 PYT Cohort 1 participants will take the T3 assessment in March 2026. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each other's assessment answers to minimize confidentiality risks.
Who: Virtual surveys will be administered by the PI and research team. Where: T3 assessment will be completed at the research site - the PYT Boys \& Girls Club How Long: T3 assessment will take 20-30 minutes to complete. How/What data: T3 assessment data will be collected virtually through Qualtrics.
Duration: T3 assessment will be completed in May 2026.
Step 10: Participant interviews
10.1 PYT Cohort 1 Participants who received the NS intervention in Spring 2026 will be recruited to participate in the participant interviews based on their quantitative assessment scores. The research team will recruit participants who are interested in being interviewed. Each participant will complete an individual, 30-60-minute interview intended to identify personal impacts of participation in the NS program on self-esteem, resilience, cultural identity, and substance use.
Who: Interviews will be conducted by the research assistants who have received training in interview procedures.
Where: Interviews will be held in private rooms at the research site - the PYT Boys \& Girls Club How/What data: Interview data will be collected with a digital recorder. How Long: Each interview will last for 30-45 minutes Duration: Spring interviews will be completed in March2026
Step 11: PYT Cohort 2 Baseline Assessment - Time 1 (T1)
11.1 PYT Cohort 2 participants will take the T1 assessment in September 2026. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each others assessment answers to minimize confidentiality risks.
Who: Virtual surveys will be administered by the PI and research team. Where: T1 assessment will be completed at the research site - the PYT Boys \& Girls Club.
How Long: T1 assessment will take 20-30 minutes to complete. How/What data: T1 assessment data will be collected virtually through REDCap. Duration: T1 assessment data will be completed in September 2026 for PYT Cohort 2.
Step 12: Fall 2026 Intervention
12.1 The wait-list group (PYT Cohort 2) will receive the intervention (NS program). Each intervention session is based on an Indigenous cultural value and cultural activity/practice that is specific to the PYT.
Who: Intervention sessions will be facilitated by local cultural knowledge holders. At least one member of the research team will attend each session to ensure fidelity Where: Intervention sessions will be held at the research site - PYT Boys \& Girls Club How Long: Each intervention session will last for 60-90 minutes, once a week for 10 weeks Duration: The Fall 2026 Cohort 2 intervention will take place from September-December 2026.
12.2 The research team will take candid pictures during the intervention that can be used for results dissemination. Any identifiable pictures with youth who do not have signed assent/consent forms will be immediately deleted.
Step 13: Follow-Up Assessment - Time 2 (T2)
13.1 PYT Cohort 2 participants will take the T2 assessment in December 2026. Surveys will be conducted virtually on participant cell phones. The research team will also print out multiple hard copies of the survey for participants who do not have access to a cell phone. Participants will sit at individual desks that are spaced so they cannot see each other's assessment answers to minimize confidentiality risks.
Who: Virtual surveys will be administered by the PI and research team. Where: T2 assessment will be completed at the research site - the PYT Boys \& Girls Club How Long: T2 assessment will take 20-30 minutes to complete. How/What data: T2 assessment data will be collected virtually through Qualtrics.
Duration: T2 assessment will be completed in December 2026.
Step 14: Participant interviews
10.1 PYT Cohort 2 Participants who received the NS intervention in Fall 2026 will be recruited to participate in the participant interviews based on their quantitative assessment scores. The research team will recruit participants who are interested in being interviewed. Each participant will complete an individual, 30-60-minute interview intended to identify personal impacts of participation in the NS program on self-esteem, resilience, cultural identity, and substance use.
Who: Interviews will be conducted by the research assistants who have received training in interview procedures.
Where: Interviews will be held in private rooms at the research site - the PYT Boys \& Girls Club How/What data: Interview data will be collected with a digital recorder. How Long: Each interview will last for 30-45 minutes Duration: Fall interviews will be completed in December 2026
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
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Exclusion:
The intervention group will receive the intervention (Native Spirit after-school program). Each intervention session is based on an Indigenous cultural value and cultural activity/practice that is specific to the community. The intervention is 10, 1.5 hour sessions that occur once/week from January-May 2025. After the Crossover the Intervention group will engage in "usual programming" August-December 2025.
Behavioral: Native Spirit After-School Program
The wait-list group will receive control or "usual" programming. Usual programming includes a life skills program that focuses on financial wellness for teens, called "Money Matters" (Usual Practice). Participants will learn valuable financial life skills. Control sessions will be facilitated by the research site partner (after-school program employees) who typically implement their usual programming. Control sessions will be held at the research site. Each control session will last for 60-90 minutes, once a week for 10 weeks taking place from August 2025 - December 2025 After the Crossover the wait-list group will receive the intervention January-March 2026 (Cohort 1) and September-December 2026 (Cohort 2).
Behavioral: Native Spirit After-School Program
Native Spirit is a culturally-grounded after-school program that is community-specific. The program is 10-sessions/weeks long and each session is 1.5-2 hours in duration. Each session is guided by a local cultural knowledge holder and is focused on a different cultural value and accompanying cultural practice. Native Spirit aims to promote self-esteem, cultural efficacy, awareness of cultural connectedness, and resilience while preventing and/or slow down the initiation of substance use.
Also known as: Native Spirit
Past 30-Day Substance Use
Data collection will focus on recent, self-reproted (past 30-day) use frequency of alcohol, cigarettes/e- cigarettes, marijuana, and other hard drugs (crystal methamphetamine, cocaine, etc.). The survey will also include a qualifying question on lifetime use of the following substances in order to measure delay of onset of use (in the case that participants have never used any of the measured substances).
Time frame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Rosenberg Self-Esteem Scale
Self-Reported measure of self-esteem using the Rosenberg self-esteem scale. The is scored by totaling the individual 4-point items after reverse-scoring the negatively worded items with a minimum score of 10 and maximum score of 40. Higher scores indicate a better outcome (stronger sense of self-esteem).
Time frame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Child and Youth Resilience Measure
Self-Reported measure of resilience using the Child and Youth Resilience Measure. The items within the measures can be directly summed to gain a total score of an individual's resilience. Responses are on a 5-point Likert scale (going from 1-5), the minimum score is 17 and the maximum score is 85. Higher scores indicate a better outcome (stronger sense of resilience).
Time frame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Cultural Efficacy
Self-Reported measure of cultural efficacy. This is on a 5-point Likert scale with a minimum score of 8 and maximum score of 40. Higher scores indicate a better outcome (cultural efficacy).
Time frame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Awareness of Connectedness Scale
Self-Reported measure of awareness of connectedness to culture using the Awareness of Connectedness Scale. This is a 3-point Likert scale with scores ranging from 12 to 36. Higher scores indicate a better outcome (stronger awareness of connectedness).
Time frame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Plan to share: No — This study includes data collection with two sovereign Native Nations in Arizona. Collected data and access to this data is ultimately under the discretion of the Tribal leadership, the departments involved, and the Office of the Attorney General.
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