Purpose

The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

Condition

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult familial caregiver of a child with CF aged <18 years - Speak English - Report smoking at least 1 cigarette in the previous week - Not enrolled in a smoking cessation program

Exclusion Criteria

  • Do not report smoking at least 1 cigarette in the previous week - Currently enrolled in a smoking cessation program.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
single-center, randomized, open-label study
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention group
The intervention group will receive the multi-component intervention (counseling with intake assessment, follow-up, help obtaining nicotine replacement therapy, and CF-specific smoke exposure education)
  • Behavioral: Tobacco Treatment Specialist (TTS) intervention
    A trained Tobacco Treatment specialist (TTS) embedded in the multi-disciplinary CF care team will provide tobacco use counseling to smoking caregivers of children with CF.
No Intervention
Control group
The control group will receive usual care plus CF-specific smoke exposure education.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Gabriela R Oates, PhD
205-638-5289
goates@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Gabriela Oates, PhD
(205)638-6908
goates@uab.edu

Detailed Description

This is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (TTS) integrated in the multidisciplinary CF care team. The intervention will be tested in a two-group design with a 2:1 allocation. Participants (dyads of caregiver/CF child) will be randomized to either intervention or control group. The intervention group (N=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and CF-specific smoke exposure education). The control group (N=12) will receive usual care plus CF-specific smoke exposure education.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.