Cystic Fibrosis
Conditions
Keywords
caregivers, tobacco, smoke exposure
Brief summary
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.
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.
Interventions
BEHAVIORALTobacco 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.
Sponsors
Cystic Fibrosis Foundation
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
single-center, randomized, open-label study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility | 6 months | Participant drop-out rates and time added to the clinical encounter |
| Intervention acceptability | 6 months | Proportion of caregivers who accepted participation; Participant and provider satisfaction with the intervention on a 1-5 Likert scale; Perceived effectiveness of the intervention on a 1-5 Likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported caregiver cessation | 6 months | 7-day point prevalence of abstinence measured at 1, 3, and 6 months; Number of cigarettes smoked in the past 7 days, measured at 1, 3, and 6 months |
| Child smoke exposure | 6 months | Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months |
Countries
United States
Outcome results
None listed