Trial Outcomes & Findings for Smoking Cessation Intervention Development for Homeless Youth (NCT NCT06754215)
NCT ID: NCT06754215
Last Updated: 2026-08-20
Results Overview
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.
TERMINATED
NA
179 participants
60 minute semi-structured interview
2026-08-20
Participant Flow
Study was terminated prior to participants being recruited into the MOST Step II - Feasibility Study arm.
Participant milestones
| Measure |
MOST Step Ib
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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
Participants take part in a study to assess the feasibility of implementing the components selected in MOST Step I in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
36
|
45
|
0
|
|
Overall Study
COMPLETED
|
98
|
36
|
45
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Intervention Development for Homeless Youth
Baseline characteristics by cohort
| Measure |
MOST Step Ia
n=36 Participants
Participants attend a semi-structured interview to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ib
n=98 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step II - Focus Groups
n=41 Participants
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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 2.0 • n=109 Participants
|
21.0 years
STANDARD_DEVIATION 2.0 • n=133 Participants
|
—
|
21.3 years
STANDARD_DEVIATION 2.3 • n=1912 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
43 Participants
n=109 Participants
|
17 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
79 Participants
n=1912 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
55 Participants
n=109 Participants
|
24 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
96 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
52 Participants
n=109 Participants
|
22 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
94 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
16 Participants
n=109 Participants
|
12 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
37 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
27 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
30 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
12 Participants
n=1912 Participants
|
|
Willingness to Quit Smoking Within the next 30 days
Willing to Quit within 30 days
|
23 Participants
n=5 Participants
|
44 Participants
n=109 Participants
|
25 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
92 Participants
n=1912 Participants
|
|
Willingness to Quit Smoking Within the next 30 days
Not Willing to Quit within 30 days
|
13 Participants
n=5 Participants
|
54 Participants
n=109 Participants
|
16 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
83 Participants
n=1912 Participants
|
PRIMARY outcome
Timeframe: 60 minute semi-structured interviewPopulation: This measure was only collected during the semi-structured interviews in MOST Step Ia.
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.
Outcome measures
| Measure |
MOST Step Ib
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
n=36 Participants
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Youth's Psychological and Physical Capacity
Stress · Yes
|
—
|
22 Participants
|
—
|
—
|
|
Youth's Psychological and Physical Capacity
Stress · No
|
—
|
14 Participants
|
—
|
—
|
|
Youth's Psychological and Physical Capacity
Nicotine Dependence · Yes
|
—
|
22 Participants
|
—
|
—
|
|
Youth's Psychological and Physical Capacity
Nicotine Dependence · No
|
—
|
14 Participants
|
—
|
—
|
|
Youth's Psychological and Physical Capacity
Daily Routine · Yes
|
—
|
10 Participants
|
—
|
—
|
|
Youth's Psychological and Physical Capacity
Daily Routine · No
|
—
|
26 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only collected from the participants who participated in MOST Step Ib; the Brief COPE questionnaire used to generate these subscales was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey. Further missing data was due to participants declining to answer items.
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.
Outcome measures
| Measure |
MOST Step Ib
n=96 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Youth's Physical and Social Factors
Positive Frame
|
6 score on a scale
Interval 5.0 to 8.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Planning
|
7 score on a scale
Interval 5.0 to 8.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Self-distracting
|
5 score on a scale
Interval 4.0 to 7.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Active Coping
|
7 score on a scale
Interval 5.0 to 8.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Denial
|
4 score on a scale
Interval 3.0 to 7.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Substance
|
4 score on a scale
Interval 2.0 to 6.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Emotional
|
5 score on a scale
Interval 4.0 to 7.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Instrumental
|
5 score on a scale
Interval 4.0 to 7.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Disengagement
|
4 score on a scale
Interval 2.0 to 5.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Venting
|
4 score on a scale
Interval 3.0 to 6.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Humor
|
5 score on a scale
Interval 2.0 to 7.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Acceptance
|
6 score on a scale
Interval 5.0 to 8.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Religion
|
5 score on a scale
Interval 3.0 to 6.0
|
—
|
—
|
—
|
|
Youth's Physical and Social Factors
Self-blame
|
5 score on a scale
Interval 4.0 to 8.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only evaluated in MOST Step Ib; this questionnaire item was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey.
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)."
Outcome measures
| Measure |
MOST Step Ib
n=96 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Motivation to Quit
No plan to quit for good
|
13 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
Next 7 days
|
13 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
Next 30 days
|
29 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
Next 6 months
|
21 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
In the next year
|
14 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
More than a year from now
|
3 Participants
|
—
|
—
|
—
|
|
Motivation to Quit
Don't know
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only evaluated in MOST Step Ib; this questionnaire item was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey. An additional 8 participants declined to respond to this item.
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?"
Outcome measures
| Measure |
MOST Step Ib
n=88 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Past Quit Attempts
|
2.83 quit attempts
Standard Deviation 4.34
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only evaluated in MOST Step Ib; this questionnaire item was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey.
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?"
Outcome measures
| Measure |
MOST Step Ib
n=96 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Confidence in Ability to Quit in Next 6 Months
Not at all likely
|
0 Participants
|
—
|
—
|
—
|
|
Confidence in Ability to Quit in Next 6 Months
A little likely
|
22 Participants
|
—
|
—
|
—
|
|
Confidence in Ability to Quit in Next 6 Months
Somewhat likely
|
45 Participants
|
—
|
—
|
—
|
|
Confidence in Ability to Quit in Next 6 Months
Very likely
|
29 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only evaluated in MOST Step Ib; the tobacco motives inventory was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey. Further missing data was due to participants declining to answer items.
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
Outcome measures
| Measure |
MOST Step Ib
n=96 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Motivations for Smoking
Social
|
7.5 score on a scale
Interval 5.0 to 10.0
|
—
|
—
|
—
|
|
Motivations for Smoking
Self-Enhancing
|
6 score on a scale
Interval 4.0 to 10.0
|
—
|
—
|
—
|
|
Motivations for Smoking
Boredom Relief
|
7 score on a scale
Interval 4.0 to 9.5
|
—
|
—
|
—
|
|
Motivations for Smoking
Affect Regulation
|
19 score on a scale
Interval 13.0 to 21.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 90 minute interviewPopulation: This scale was only evaluated in MOST Step Ib; this set of items was not administered to participants in MOST Step Ia or II and there are no plans to collect this data in the future. 2 participants were excluded as they provided unreliable responses throughout the survey. Further missing data was due to participants declining to answer items.
We measured 15 different rewards from smoking: "What are the benefits of smoking to you? Check all that apply"
Outcome measures
| Measure |
MOST Step Ib
n=96 Participants
Participants complete a survey to help establish the theoretical model of contextually tailored smoking cessation for homeless youth.
|
MOST Step Ia
Participants attend a semi-structured interview to help establish the 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 the focus groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services.
|
|---|---|---|---|---|
|
Rewards From Quitting Smoking
Relieves my urge to smoke · Not Endorsed
|
41 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves my urge to smoke · Endorsed
|
54 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
It is calming · Not Endorsed
|
15 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
It is calming · Endorsed
|
81 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
It is comforting · Not Endorsed
|
35 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
It is comforting · Endorsed
|
61 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Keeps me from feeling hungry · Not Endorsed
|
67 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Keeps me from feeling hungry · Endorsed
|
29 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Keeps my hands busy · Not Endorsed
|
43 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Keeps my hands busy · Endorsed
|
53 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps me fit in · Not Endorsed
|
66 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps me fit in · Endorsed
|
30 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves stress · Not Endorsed
|
12 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves stress · Endorsed
|
84 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves boredom · Not Endorsed
|
35 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves boredom · Endorsed
|
61 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves anxiety · Not Endorsed
|
18 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves anxiety · Endorsed
|
78 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves depression · Not Endorsed
|
42 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Relieves depression · Endorsed
|
54 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
I like the taste · Not Endorsed
|
49 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
I like the taste · Endorsed
|
47 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps me socialize · Not Endorsed
|
58 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps me socialize · Endorsed
|
38 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Excuse to get out of dangerous situations · Not Endorsed
|
56 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Excuse to get out of dangerous situations · Endorsed
|
38 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Prevents me from being violent · Not Endorsed
|
52 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Prevents me from being violent · Endorsed
|
44 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps control my anger · Not Endorsed
|
40 Participants
|
—
|
—
|
—
|
|
Rewards From Quitting Smoking
Helps control my anger · Endorsed
|
56 Participants
|
—
|
—
|
—
|
Adverse Events
MOST Step Ia
MOST Step Ib
MOST Step II - Focus Groups
MOST Step II - Feasibility Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place