Smoking Cessation Intervention Development for Homeless Youth

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Focus Group; Other: Interview; Behavioral: Smoking Cessation Intervention

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: Interventional
• Enrollment (Estimated): 298
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Julianna Nemeth; Phone Number: 614-247-7142
      • Principal Investigator: Julianna Nemeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

4

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.	Other: Interview; 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.	Other: Survey Administration; 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.	Behavioral: Smoking Cessation Intervention; Participate in feasibility study of intervention components; Other Names: Smoking and Tobacco Use Cessation Interventions
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.	Behavioral: Focus Group; Participate in focus group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Julianna Nemeth, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No