- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06754215
Smoking Cessation Intervention Development for Homeless Youth
Development of a Contextually Tailored and Optimized Smoking Cessation Intervention for Homeless Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MOST STEP Ia (interview)
Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
|
Participate in semi-structured interview
|
|
Experimental: MOST STEP Ib (survey)
Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.
|
Complete survey
|
|
Experimental: 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.
|
Participate in feasibility study of intervention components
Other Names:
|
|
Experimental: 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.
|
Participate in focus group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
60 minute semi-structured interview
|
|
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.
|
Approximately 90 minute interview
|
|
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)."
|
Approximately 90 minute interview
|
|
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?"
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Approximately 90 minute interview
|
|
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?"
|
Approximately 90 minute interview
|
|
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 |
Approximately 90 minute interview
|
|
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"
|
Approximately 90 minute interview
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julianna Nemeth, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Manufactured Materials
- Technology, Industry, and Agriculture
- Interviews as Topic
- Focus Groups
- Smoking Devices
Other Study ID Numbers
- OSU-17281
- NCI-2019-02248 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- K07CA216321 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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