NCT06754215

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

8.3 years

First QC Date

December 17, 2024

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Youth's psychological and physical capacity (capability)

    Participant's psychological and physical capacity that have prompted them in the past or may motivate them to 1) smoke, 2) make a quit attempt, and 3) engage in supported cessation will be captured. An iterative approach to team-based codebook development and coding will be used to analyze interview data. In Stage 1, text will be coded according to the specific research question using structural codes. In Stage 2, in depth codes will be created using emergent themes from the structurally coded text. The coders will create as many in depth codes as needed in order to capture all aspects of youth's perspective on current psychosocial influences on smoking, and the psychological and physical capacities critical to engagement in tobacco cessation intervention. Data is separated by the age cut-off for standard recommendations regarding cessation intervention (14-17 and 18-24) to assess if differences exist that should be considered for intervention in homeless drop in centers.

    Up to 3 years

  • Youth's physical and social factors (opportunity)

    Participant's physical and social factors (opportunity) that have prompted them in the past or may motivate them to 1) smoke, 2) make a quit attempt, and 3) engage in supported cessation will be captured. In Stage 1, text will be coded according to the specific research question using structural codes. In Stage 2, in depth codes will be created using emergent themes from the structurally coded text. The coders will create as many in depth codes as needed in order to capture all aspects of youth's perspective on current psychosocial influences on smoking, and the physical and social opportunities critical to engagement in tobacco cessation intervention. Data is separated by the age cut-off for standard recommendations regarding cessation intervention (14-17 and 18-24) to assess if differences exist that should be considered for intervention in homeless drop in centers.

    Up to 3 years

Study Arms (4)

MOST STEP Ia (interview)

EXPERIMENTAL

Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

Other: Interview

MOST STEP Ib (survey)

EXPERIMENTAL

Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

Other: Survey Administration

MOST STEP II (feasibility study)

EXPERIMENTAL

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.

Behavioral: Smoking Cessation Intervention

MOST STEP II (focus groups)

EXPERIMENTAL

Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.

Behavioral: Focus Group

Interventions

Focus GroupBEHAVIORAL

Participate in focus group

MOST STEP II (focus groups)

Participate in semi-structured interview

MOST STEP Ia (interview)

Participate in feasibility study of intervention components

Also known as: Smoking and Tobacco Use Cessation Interventions
MOST STEP II (feasibility study)

Complete survey

MOST STEP Ib (survey)

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Focus GroupsInterviews as TopicSmoking Devices

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Julianna Nemeth

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 31, 2024

Study Start

September 20, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations