Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being (Kamaehu)

Kamaehu o ke Kaiāulu: Fostering Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being

The goal of this pilot clinical trial is to learn if a community referral program can improve services for youth with mental health and chronic health conditions in a predominantly Native Hawaiian and Pacific Islander community. The main questions the trial aims to address are:

  • What is the best way for a community health center to connect youth with community programs rooted in cultural practices and traditions?
  • Does participation in community programs engage youth and mental health and chronic health outcomes?

Participants will:

  • Participate in a community program for youth that will strengthen connection to 'āina (land) and culture. Programs in the summer are 5 hours per day, 4 days a week, for 4 weeks. Programs in the school-year are 2.5 hours per day, 2 days a week, for 16 weeks.
  • Take surveys on their demographics, general well-being, mental health, and chronic health conditions they may have at 4 different times: Before the program begins, immediately after the program finishes, 3-4 months after finishing, and 6-8 months after finishing.
  • Have an adult family member complete surveys on their youth's demographics and general well-being at the same 4 times

Study Overview

Detailed Description

Pilot Clinical Trial Aim: To evaluate the effectiveness and implementation of community organizations' Kaiona Programs in improving adolescent and young adult health and well-being.

Objectives:

  1. Assess the effectiveness of the Kaiona Programs in enhancing health and well-being outcomes among adolescents using a stepped wedge cluster randomized trial.
  2. Evaluate the implementation of fidelity, dosage, and reach of the intervention across different community organizations.
  3. Identify barriers and facilitators to successful implementation that can inform subsequent scaling of the program and share results with 'Aha Kū community council members and other key partners

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Backup

Study Locations

    • Hawaii
      • Waianae, Hawaii, United States, 96792
        • Recruiting
        • Waianae Coast Comprehensive Health Center
        • Contact:
        • Principal Investigator:
          • May M Okihiro, MD, MS

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • youth 12 to 25 years of age;
  • live in the Wai'anae zip code 96792;
  • utilize Waianae Coast Comprehensive Health Center (WCCHC) for their healthcare, including the WCCHC School-based Health Centers;
  • assessed by WCCHC providers as being "at-promise" or having a physical or behavioral/mental health concern that may benefit from further support from Kaiona CBO Programs. Conditions may include chronic disease risk factors such as asthma, obesity, diabetes, or prediabetes, as well as behavioral health concerns.

Exclusion Criteria:

  • Rather than strict exclusionary criteria, we will rely on the onboarding process that allows for screening for program fit at 4 levels: the referring Pediatric/Behavioral Health provider, the Community Connections Manager, the youth participant/family member, and the receiving CBO. All 4 of these levels will need to assess a potential participant as fit to participate. General considerations include ability to work in groups with other youth, ability to be outdoors for hours at a time, and ability to receive basic instruction and complete basic physical and cognitive tasks associated with the program independently. All 4 layers will also have the opportunity to end the youth's participation in the program at any point if serious safety or health concerns arise for the participant or others involved in the program. If a participant needs to leave a program, the Community Connections Manager will remain engaged with the youth and family to explore other options through the pilot or elsewhere.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kaiona Programs Arm
Single arm
Youth will be recruited to participate in 'āina-based (natural environment-based) Kaiona programming at one of 5 well known community-based organizations. 1) Hoa 'Āina o Mākaha; 2) Ka'ala Farm; 3) E Ala Voyaging Academy; 4) PALS; and 5) MA'O Organic Farm. The program will consist of approximately 80 hours of Kaiona programming through an assigned CBO, delivered either as a summer intensive (four weeks, four days per week, five hours per day) or semester-long format (16 weeks, two days per week, 2.5 hours per day). This dosage provides meaningful cultural engagement while accommodating family and academic obligations. While Kaiona programming will not be strictly scripted, all programs will feature activities that promote cultural values identified by community leaders as foundational to the local perception of health and well being.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Kaiona Survey Participant Responses
Time Frame: 4 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, 3-4 months after program completion, and 6-8 months after program completion
The Kaiona Survey is an instrument developed to measure health and wellness based on local community values, embodied in the Kaiona Framework. In this framework, wellness is embodied by four values: mauli ola, a balanced state of physical, mental, emotional, spiritual, and environmental health; waiwai, abundance and prosperity; pilina, mutually sustaining relationships; and ea, self-determination and agency.
4 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, 3-4 months after program completion, and 6-8 months after program completion
Change from Baseline in Harvard Adolescent Flourishing Measure
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
The Harvard Adolescent Flourishing Measure is a 12-item survey to measure adolescent well-being around 5 domains - happiness and life satisfaction, physical and mental health, meaning and purpose, character and virtue, and close social relationships.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Change from Baseline in PHQ-9 Modified for Adolescents Survey
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
The PHQ-9 Modified for Adolescents Survey (PHQ-A) is a 13-item self-administered tool to screen and measure severity of depression based on the DSM-IV criteria. 3 items specifically screen for suicidal ideation or thoughts of self-harm.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Change from Baseline in Pediatric Symptom Checklist
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
The Pediatric Symptom Checklist is a 17-item screening survey for youth 11 years and older to facilitate recognition of cognitive, emotional, and behavioral concerns.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Change from Baseline in Positive Childhood Experiences Score
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
The Positive Childhood Experiences Score (PCE) is a 7-item survey to retrospectively assess positive childhood experiences, especially interpersonal experiences that serve as assets and resources for developing children.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Asthma Control Test
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Survey will be given to those participants who enter the program with an existing diagnosis of asthma.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Change from Baseline in Diabetes Self-Care Inventory
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Survey will be given to those participants who enter the program with an existing diagnosis of diabetes.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Change from Baseline in Obesity Pediatric Weight Questionnaire
Time Frame: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion
Survey will be given to those participants who enter the program with an existing diagnosis of overweight/obesity.
3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: May M Okihrio, MD, MS, Waianae Coast Comprehensive Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ferenchak KS, Garcia BK, Maunakea-Forth JK, Jay CV, Pule I, Enos E, Fukuda KL, Engle A, Cruz CK, Keleb M, Raza-Furtado A. The Kaiona Framework: Centering Hawaiian and Pasifika Community in Defining, Measuring, and Promoting Health and Well-Being. International Journal of Environmental Research and Public Health. 2026 Mar.

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 (Actual)

April 10, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Working in a predominantly indigenous community, the research team is actively exploring issues related to data sovereignty that will ultimately shape our plans for sharing individual participant data.

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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