RecruitingNot Applicable

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

United States100 participantsStarted 2026-04-10

Plain-language 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

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Kaiona Survey Participant Responses

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion

Trial details

NCT IDNCT07536256

SponsorWaianae Coast Comprehensive Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-31

Contact for this trial

Kenny S Ferenchak, MD, MEdT

808-697-3433 kenneth7@hawaii.edu

View on ClinicalTrials.gov More Chronic Disease trials

Plain-language summary

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline in Kaiona Survey Participant Responses

Change from Baseline in Harvard Adolescent Flourishing Measure

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion