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Smoking Cessation Intervention Development for Homeless Youth

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754215
Enrollment
179
Registered
2024-12-31
Start date
2017-09-20
Completion date
2023-04-26
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking-Related Carcinoma

Brief summary

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.

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.

Interventions

BEHAVIORALFocus Group

Participate in focus group

OTHERInterview

Participate in semi-structured interview

BEHAVIORALSmoking Cessation Intervention

Participate in feasibility study of intervention components

OTHERSurvey Administration

Complete survey

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Youth's Psychological and Physical Capacity60 minute semi-structured interviewFactors 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 FactorsApproximately 90 minute interviewCoping 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 QuitApproximately 90 minute interviewInterest 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 AttemptsApproximately 90 minute interviewNumber 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 MonthsApproximately 90 minute interviewConfidence 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 SmokingApproximately 90 minute interviewThe 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 SmokingApproximately 90 minute interviewWe measured 15 different rewards from smoking: "What are the benefits of smoking to you? Check all that apply"

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJulianna Nemeth

Ohio State University Comprehensive Cancer Center

Participant flow

Recruitment details

Study was terminated prior to participants being recruited into the MOST Step II - Feasibility Study arm.

Baseline characteristics

Characteristic
Age, Continuous21.3 years
STANDARD_DEVIATION 2.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
94 Participants
Race (NIH/OMB)
More than one race
27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
37 Participants
Sex: Female, Male
Female
79 Participants
Sex: Female, Male
Male
17 Participants
Willingness to Quit Smoking Within the next 30 days
Not Willing to Quit within 30 days
16 Participants
Willingness to Quit Smoking Within the next 30 days
Willing to Quit within 30 days
92 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 980 / 450 / 0
other
Total, other adverse events
0 / 360 / 980 / 450 / 0
serious
Total, serious adverse events
0 / 360 / 980 / 450 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026