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Terminated

NCT Number: NCT06754215

Smoking Cessation Intervention Development for Homeless Youth

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.

Why the study stopped: The study did not progress to full completion due to an unanticipated prolonged medical leave of absence of the Principal Investigator. This extended interruption resulted in early termination before completion of all planned activities.
Terminated

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Key information

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

MOST STEP II (FOCUS GROUPS): Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.

MOST STEP II (FEASIBILITY STUDY): 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Focus Group

Behavioral

Participate in focus group

interview

Other

Participate in semi-structured interview

Smoking Cessation Intervention

Behavioral

Participate in feasibility study of intervention components

Other names: Smoking and Tobacco Use Cessation Interventions

Survey Administration

Other

Complete survey

Primary outcomes

  1. Youth's Psychological and Physical Capacity

    Time frame: 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.

  2. Youth's Physical and Social Factors

    Time frame: 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.

  3. Motivation to Quit

    Time frame: 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)."

  4. Past Quit Attempts

    Time frame: 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?"

  5. Confidence in Ability to Quit in Next 6 Months

    Time frame: 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?"

  6. Motivations for Smoking

    Time frame: 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

  7. Rewards From Quitting Smoking

    Time frame: Approximately 90 minute interview

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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 31, 2024
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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