NCT07536256

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Aug 2028

First Submitted

Initial submission to the registry

April 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Adolescent Health ServicesCommunity Health CentersMental Health ServicesNative Hawaiian or Other Pacific IslanderCommunity Health ServicesAdolescentYoung AdultChildyouth mental health

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in Kaiona Survey Participant Responses

    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

    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

    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

    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

    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 Outcomes (3)

  • 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

Study Arms (1)

Kaiona Programs Arm

EXPERIMENTAL

Single arm

Behavioral: Community Referral to Kaiona Programs

Interventions

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.

Kaiona Programs Arm

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waianae Coast Comprehensive Health Center

Waianae, Hawaii, 96792, United States

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Chronic DiseaseObesityOverweightPrediabetic StateAsthma

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • May M Okihrio, MD, MS

    Waianae Coast Comprehensive Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenny S Ferenchak, MD, MEdT

CONTACT

Blane K Garcia, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Hybrid type 2 design with stepped wedge intervention design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations