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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

179 participants

Primary outcome timeframe

60 minute semi-structured interview

Results posted on

2026-08-20

Participant Flow

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

Participant milestones

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

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 interview

Population: 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

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 interview

Population: 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

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 interview

Population: 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

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 interview

Population: 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

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 interview

Population: 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

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 interview

Population: 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

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 interview

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MOST Step Ib

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MOST Step II - Focus Groups

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MOST Step II - Feasibility Study

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julianna Nemeth

Ohio State University

Phone: (614)247-7142

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place