跳至主要内容
临床试验/NCT06754215
NCT06754215终止不适用

Development of a Contextually Tailored and Optimized Smoking Cessation Intervention for Homeless Youth

Ohio State University Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
179
试验地点
2
主要终点
Youth's psychological and physical capacity (capability)

研究概览

简要总结

This trial develops a contextually tailored and optimized smoking cessation intervention and studies smoking motivations and motivations to quit smoking in homeless youth. Identifying motivations for smoking and motivations to quit smoking may help researchers build a program to help homeless young people quit smoking cigarettes if desired.

详细描述

PRIMARY OBJECTIVES:

I. Establish a theoretical framework for cessation among homeless youth incorporating phase-specific capabilities and opportunities impacting motivation to engage in cessation. (Multiphase Optimization STrategy [MOST] Step 1) II. Guided by the theoretical framework for cessation among homeless youth, identify a set of cessation intervention components and assess their implementation feasibility. (MOST Step 2)

OUTLINE:

MOST STEP Ia: Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

MOST STEP Ib: Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Youth who report having smoked some or every day in the past week.
  • Youth who meet criteria for homelessness defined by the 2002 McKinney-Vento Act including those who lack a fixed, regular, and adequate nighttime residence; live in a welfare hotel, or place without regular sleeping accommodations; or live in a shared residence with other persons due to the loss of one's housing or economic hardship.

排除标准

  • 未提供

研究组 & 干预措施

MOST STEP Ia (interview)

Experimental

Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

干预措施: Interview (Other)

MOST STEP Ib (survey)

Experimental

Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

干预措施: Survey Administration (Other)

MOST STEP II (feasibility study)

Experimental

Intervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies.

干预措施: Smoking Cessation Intervention (Behavioral)

MOST STEP II (focus groups)

Experimental

Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.

干预措施: Focus Group (Behavioral)

结局指标

主要结局

Youth's psychological and physical capacity (capability)

时间窗: Up to 3 years

Participant's psychological and physical capacity that have prompted them in the past or may motivate them to 1) smoke, 2) make a quit attempt, and 3) engage in supported cessation will be captured. An iterative approach to team-based codebook development and coding will be used to analyze interview data. In Stage 1, text will be coded according to the specific research question using structural codes. In Stage 2, in depth codes will be created using emergent themes from the structurally coded text. The coders will create as many in depth codes as needed in order to capture all aspects of youth's perspective on current psychosocial influences on smoking, and the psychological and physical capacities critical to engagement in tobacco cessation intervention. Data is separated by the age cut-off for standard recommendations regarding cessation intervention (14-17 and 18-24) to assess if differences exist that should be considered for intervention in homeless drop in centers.

Youth's physical and social factors (opportunity)

时间窗: Up to 3 years

Participant's physical and social factors (opportunity) that have prompted them in the past or may motivate them to 1) smoke, 2) make a quit attempt, and 3) engage in supported cessation will be captured. In Stage 1, text will be coded according to the specific research question using structural codes. In Stage 2, in depth codes will be created using emergent themes from the structurally coded text. The coders will create as many in depth codes as needed in order to capture all aspects of youth's perspective on current psychosocial influences on smoking, and the physical and social opportunities critical to engagement in tobacco cessation intervention. Data is separated by the age cut-off for standard recommendations regarding cessation intervention (14-17 and 18-24) to assess if differences exist that should be considered for intervention in homeless drop in centers.

Youth's Psychological and Physical Capacity

时间窗: 60 minute semi-structured interview

Factors associated with participant's psychological and physical capacity which have prompted them to smoke in the past were captured during semi-structured interviews. In-person interviews followed a semi-structured interview guide. Questions were grounded in the Capability-Opportunity-Motivation for Behavior model, a theoretical framework that describes how intersecting psychosocial and environmental factors influence behavior. Questions were designed to elicit data on factors influencing tobacco use at a specific moment in time (participants' "last smoke") with the intent to optimize supportive cessation interventions for this population.

Youth's Physical and Social Factors

时间窗: Approximately 90 minute interview

Coping with homelessness was assessed using the Brief COPE to examine strategies used for coping or regulating cognition in response to stressors; participants were specifically asked to focus on their housing situation. This measure includes 28 items combined to form 14 subscales. Scores on each subscale range from 2 to 8 with higher scores indicating greater use of the strategy.

Motivation to Quit

时间窗: Approximately 90 minute interview

Interest in quitting in the next 30 days is an exemplar Phase-Based Model (PBM) for Cessation Research motivation phase treatment outcome measure. Participants reported if and when they planned to quit, derived from, "Do you plan to quit for good?" and "When do you plan to quit for good? In the next (7 days, 30 days, 6 months, year, more than a year from now)."

Past Quit Attempts

时间窗: Approximately 90 minute interview

Number of past year quit attempts: a proxy for past willingness to quit. Participants reported the number of quit attempts in the past year: "In the past 12 months, how many times have you quit smoking for at least 24 hours in a serious attempt to quit?"

Confidence in Ability to Quit in Next 6 Months

时间窗: Approximately 90 minute interview

Confidence in ability to quit in the next 6 months was measured with: "If you did try quitting smoking altogether in the next 6 months, how likely do you think you would be to succeed - not at all, a little likely, somewhat likely or very likely?"

Motivations for Smoking

时间窗: Approximately 90 minute interview

The Tobacco Motives Inventory was used; 15 questions, each scored on a 5-point Likert scale, were combined into four sub-scales: social motives, self enhancement motives, boredom relief motives, and affect regulation motives. Higher scores on each sub-scale indicate a higher motivation to smoke. Social motives: Sum of 4 items, scores range from 4 to 20 Self enhancement motives: Sum of 4 items, scores range from 4 to 20 Boredom relief motives: Sum of 2 items, scores range from 2 to 10 Affect regulation motives: Sum of 5 items, scores range from 5 to 25

Rewards From Quitting Smoking

时间窗: Approximately 90 minute interview

We measured 15 different rewards from smoking: "What are the benefits of smoking to you? Check all that apply"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julianna Nemeth

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (2)

Loading locations...

相似试验