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Smoke-Free Home Program for Reducing Child Exposure to Smoking (SFSC Trial)

N/A
Recruiting
Led By Shannon Self-Brown, PhD
Research Sponsored by Georgia State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this item may change over time so it will be assessed at baseline, 8-week, 20-week, and 1-year (i.e. employment status, number of children, etc.)
Awards & highlights

SFSC Trial Summary

This trial intervention consists of two parts: Some Things are Better Outside (STBO), which promotes smoke-free homes, and SafeCare, which reduces child maltreatment and improves mother-child outcomes. STBO is effective in creating smoke-free homes and reducing second-hand smoke in low-SES households. SafeCare is an effective parent training program that is broadly disseminated in child protective services in the United States. SafeCare is a promising mechanism to effectively increase the reach of STBO to reduce SHS exposure in families with documented high rates of tobacco use and children with cumulative risk for negative health outcomes.

Who is the study for?
This trial is for SafeCare providers who have completed specific training and work in high-smoking areas, as well as mothers aged 18+ with a child protection case, who smoke or live with a smoker at home, and have a child between ages 0-5 (or 0-9 in Oklahoma).Check my eligibility
What is being tested?
The study tests Smoke Free SafeCare (SFSC), which combines promoting smoke-free homes (STBO) and parent training to reduce child maltreatment (SafeCare). It's compared against the standard SafeCare program to see if it better reduces secondhand smoke exposure.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not applicable. However, participants may experience stress or discomfort when changing smoking habits or during parenting training.

SFSC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this item may change over time so it will be assessed at baseline, 8-week, 20-week, and 1-year (i.e. employment status, number of children, etc.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and this item may change over time so it will be assessed at baseline, 8-week, 20-week, and 1-year (i.e. employment status, number of children, etc.) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Smoke
Smoke
Smoke Free Home Rules (Questionnaire)
+1 more
Secondary outcome measures
Parenting Stress Inventory (PSI)
Parenting Young Children Survey (PYCS)
Perceived Stress Scale
+1 more
Other outcome measures
Demographic - Age
Demographic - Disability
Demographic - Education
+8 more

SFSC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smoke Free SafeCare (SFSC)Experimental Treatment1 Intervention
Providers randomized to this group will receive additional SFSC training and will disseminate SFSC program to families who report having a smoker in the home.
Group II: Standard SafeCareActive Control1 Intervention
Providers randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home.

Find a Location

Who is running the clinical trial?

Georgia State UniversityLead Sponsor
58 Previous Clinical Trials
24,869 Total Patients Enrolled
Shannon Self-Brown, PhDPrincipal InvestigatorGeorgia State University
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Smoke Free SafeCare Clinical Trial Eligibility Overview. Trial Name: NCT05000632 — N/A
Child Abuse Research Study Groups: Standard SafeCare, Smoke Free SafeCare (SFSC)
Child Abuse Clinical Trial 2023: Smoke Free SafeCare Highlights & Side Effects. Trial Name: NCT05000632 — N/A
Smoke Free SafeCare 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000632 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment restricted to those over 45 years old?

"This medical trial has predetermined age limitations. The lower bound is 18 and the upper limit is 89."

Answered by AI

How many participants have been accepted to take part in this medical experiment?

"Affirmative. The information posted to clinicaltrials.gov attests that this trial is actively seeking 600 participants from 2 distinct medical facilities. It was initially uploaded on April 19th 2022 and last edited on November 2nd of the same year."

Answered by AI

Are any new volunteers being accepted for this clinical experiment?

"The data on clinicaltrials.gov indicates that this trial is presently in search of participants, having first been announced on April 19th 2022 and most recently amended November 2nd 2022."

Answered by AI

Is it feasible for me to join this clinical investigation?

"This medical trial is recruiting 600 individuals with smoking tendencies, aged between 18 and 89. In order to be eligible for the study, SafeCare providers must have completed a workshop and passed field certification while employed at an accredited agency in one of the CDC-specified states or regions where prior research has identified high rates of smoking. Mothers participating in this trial must also meet certain criteria: they need to be referred as part of a child protection case; report either their own or another person's (who resides 3 nights per week) smoking behavior; be above 18 years old; and parent children aged 0 - 5 (or 0-9 if residing in"

Answered by AI

What is the desired outcome of this medical experiment?

"This research project will be measuring the Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation. Secondary metrics employed to assess this include Parenting Stress Inventory (PSI), Perceived Stress Scale, and Devereux Early Childhood Assessment (DECA). Collectively they provide insight into parenting stress, personal stress levels, and parent-child relationships over a one year period."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Georgia State University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
Shannon Self-Brown 2022. "Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05000632.
~317 spots leftby Oct 2026
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