Recruiting

Community Program

Sponsor:

Waianae Coast Comprehensive Health Center

Code:

NCT07536256

Conditions

Chronic Disease

Adolescent Asthma

Obesity & Overweight

Youth Mental Health

Youth Obesity

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Community Referral to Kaiona Programs

Study Details

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

Conditions

Chronic Disease

Adolescent Asthma

Obesity & Overweight

Youth Mental Health

Youth Obesity

Study ID

NCT07536256

Start date

Apr 10, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Kaiona Programs Arm

Single arm

Interventions

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, 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kenny S Ferenchak, MD, MEdT

808-697-3433kenneth7@hawaii.edu

Blane K Garcia, MPH

808-697-3272blanekc@hawaii.edu

Locations

Waianae Coast Comprehensive Health Center

Recruiting

Waianae, Hawaii, United States, 96792

Contacts

Blane K Garcia, MPH

808-697-3272blanekc@hawaii.edu

Principal Investigator:

May M Okihiro, MD, MS

More Information

Sponsor

Waianae Coast Comprehensive Health Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Adolescent Health Services
  • Community Health Centers
  • Mental Health Services
  • Native Hawaiian or Other Pacific Islander
  • Community Health Services
  • Adolescent
  • Young Adult
  • Child
  • youth mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Waianae Coast Comprehensive Health Center on 2026-04-17.