跳至主要内容
临床试验/NCT07536256
NCT07536256招募中不适用

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

Waianae Coast Comprehensive Health Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change from Baseline in Kaiona Survey Participant Responses

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Kaiona Programs Arm

Experimental

Single arm

干预措施: Community Referral to Kaiona Programs (Behavioral)

结局指标

主要结局

Change from Baseline in Kaiona Survey Participant Responses

时间窗: 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.

Change from Baseline in Harvard Adolescent Flourishing Measure

时间窗: 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.

Change from Baseline in PHQ-9 Modified for Adolescents Survey

时间窗: 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.

Change from Baseline in Pediatric Symptom Checklist

时间窗: 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.

Change from Baseline in Positive Childhood Experiences Score

时间窗: 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.

次要结局

  • Change from Baseline in Asthma Control Test(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(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(3 time points: Baseline at enrollment, immediate endpoint within 1-2 weeks of completion of intervention program, and 6-8 months after program completion)

研究者

发起方
Waianae Coast Comprehensive Health Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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