- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536256
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
Status
Conditions
Intervention / Treatment
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:
- Assess the effectiveness of the Kaiona Programs in enhancing health and well-being outcomes among adolescents using a stepped wedge cluster randomized trial.
- Evaluate the implementation of fidelity, dosage, and reach of the intervention across different community organizations.
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kenny S Ferenchak, MD, MEdT
- Phone Number: 808-697-3433
- Email: kenneth7@hawaii.edu
Study Contact Backup
- Name: Blane K Garcia, MPH
- Phone Number: 808-697-3272
- Email: blanekc@hawaii.edu
Study Locations
-
-
Hawaii
-
Waianae, Hawaii, United States, 96792
- Recruiting
- Waianae Coast Comprehensive Health Center
-
Contact:
- Blane K Garcia, MPH
- Phone Number: 808-697-3272
- Email: blanekc@hawaii.edu
-
Principal Investigator:
- May M Okihiro, MD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: May M Okihrio, MD, MS, Waianae Coast Comprehensive Health Center
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Pathologic Processes
- Nutrition Disorders
- Disease Attributes
- Metabolic Diseases
- Overnutrition
- Body Weight
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Asthma
- Prediabetic State
- Chronic Disease
Other Study ID Numbers
- NIH: ODTOD035880-01
- 3OT2OD035880-01S2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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