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| ID | Type | Description | Link |
|---|---|---|---|
| 3OT2OD035880-01S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Hawaii | OTHER |
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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:
Participants will:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kaiona Programs Arm | Experimental | Single arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Referral to Kaiona Programs | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Asthma Control Test | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenny S Ferenchak, MD, MEdT | Contact | 808-697-3433 | kenneth7@hawaii.edu | |
| Blane K Garcia, MPH | Contact | 808-697-3272 | blanekc@hawaii.edu |
| Name | Affiliation | Role |
|---|---|---|
| May M Okihrio, MD, MS | Waianae Coast Comprehensive Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waianae Coast Comprehensive Health Center | Recruiting | Waianae | Hawaii | 96792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41899779 | Background | 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. doi: 10.3390/ijerph23030402. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 8, 2026 | Apr 10, 2026 |
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Hybrid type 2 design with stepped wedge intervention design
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|
| 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 |
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 | 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 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D009765 | Obesity |
| D050177 | Overweight |
| D011236 | Prediabetic State |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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