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Recruiting NCT07536256

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

No phase Interventional Chronic Disease Adolescent Asthma Obesity & Overweight Youth Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community Referral to Kaiona Programs.
Who it may be relevant to
Registry conditions: Chronic Disease, Adolescent Asthma, Obesity & Overweight, Youth Mental Health. Basic parameters: 12 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral Community Referral to Kaiona Programs
    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,

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Waianae Coast Comprehensive Health Center — Waianae

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, Spahn Naihe A, Aoki A, Ewaliko F, Schnackenberg UON, Akiyama KMCD, Panui AM, Chang KK, Okihiro M. The Kaiona Framework: Centering Hawaiian and Pasifika Community in Defining, Measuring, and Promoting Health and Well-Being. Int J Environ Res Public Health. 2026 Mar 22;23(3):402. PMID 41899779

Identifiers

NCT: NCT07536256 · NIH: ODTOD035880-01 · 3OT2OD035880-01S2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗