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Clinical Trials/NCT07536256
NCT07536256RecruitingNot Applicable

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

Waianae Coast Comprehensive Health Center1 site in 1 country100 target enrollmentStarted: April 10, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Change from Baseline in Kaiona Survey Participant Responses

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Kaiona Programs Arm

Experimental

Single arm

Intervention: Community Referral to Kaiona Programs (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Change from Baseline in Asthma Control Test(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(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(3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion)

Investigators

Sponsor
Waianae Coast Comprehensive Health Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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