NCT06785311

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Jan 2025Aug 2027

Study Start

First participant enrolled

January 9, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 11, 2025

Last Update Submit

February 13, 2026

Conditions

Keywords

American IndianAdolescent HealthPreventionAfter-School Programs

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    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).

    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).

    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).

    Baseline, Immediately Post-Invervention, 3 months follow-up post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Wait-List Group

ACTIVE COMPARATOR

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

Interventions

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
Intervention GroupWait-List Group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Non-American Indians will be excluded from statistical analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Way of Life Facility

Scottsdale, Arizona, 85256, United States

RECRUITING

Pascua Yaqui Tribe Boys & Girls Club

Tucson, Arizona, 85746, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersUnderage DrinkingSuicide Prevention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAdolescent BehaviorBehaviorAlcohol DrinkingDrinking BehaviorSuicideSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

  • Amanda Hunter, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Hunter, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Wait-list controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 21, 2025

Study Start

January 9, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations