Clinical trial NCT06785311: Native Spirit: Significant Aim 3: Intervention
Official title: Native Spirit: Culturally-grounded Substance Use Prevention for Indigenous Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Self Esteem
Youth Drinking
Prevention, Suicide
Keywords: American Indian
Adolescent Health
Prevention
After-School Programs
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Wait-list controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 May-July2025 for PYT.

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 Drcember 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) 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 March 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 intervention will take place from January-May 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 participants will take the T3 assessment in May 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 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: Fall interviews will be completed between May-June 2026

Eligibility criteria: Inclusion:

* English-speaking
* Currently in grade 7-12 at time of enrollment
* Member of the Salt River Pima Maricopa Indian Community (SRPMIC) OR member of the Pascua Yaqui Tribe (PYT)
* Engaged in after school programs.

Exclusion:

• Non-American Indians will be excluded from statistical analysis

Primary outcomes:
measure: Past 30-Day Substance Use
timeFrame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
measure: Child and Youth Resilience Measure
timeFrame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
measure: Cultural Efficacy
timeFrame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
measure: Awareness of Connectedness Scale
timeFrame: Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Way of Life Facility
state: Arizona
city: Tucson
country: United States
facility: Pascua Yaqui Tribe Boys & Girls Club
state: Arizona
Study officials:
affiliation: Assistant Professor
name: Amanda Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References: