Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families (NCT05000632) | Clinical Trial Compass
RecruitingNot Applicable
Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
United States268 participantsStarted 2022-04-19
Plain-language summary
Smoke Free SafeCare (SFSC) is a proposed braided intervention consisting of two evidence-based interventions: Some Things are Better Outside (STBO), aimed at promoting smoke free home rules, and SafeCare, aimed at reducing child maltreatment and improving mother and child outcomes. STBO is effective in creating smoke free homes and reducing second-hand smoke in low-SES (socioeconomic status) 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 (secondhand smoke) exposure in families with documented high rates of tobacco use and children with cumulative risk for negative health outcomes.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Provider Inclusion Criteria:
* SafeCare providers in this study must 1) have completed the SafeCare workshop and passed field Certification (9 sessions of SafeCare delivered with fidelity according to the SafeCare Fidelity Checklist); 2) be employed at an accredited SafeCare agency in a target state based on Centers for Disease Control and Prevention (CDC) adult smoking data or prior SafeCare research documenting high smoking rates.
Caregiver Inclusion Criteria:
* Caregivers in this study must meet the following inclusion criteria to participate: 1) Referred to a SafeCare Provider study participant; 2) Reports in-home smoking behavior by herself or another person (person must reside in the home 3 or more nights a week) 3) Caregiver must be aged 18 or older and 4) Mother must be a parent to a child between the ages of 0 and 5 (or 0 - 9 if in the state of Oklahoma).
Provider Exclusion Criteria:
* SafeCare providers will be excluded if they have planned for significant employment leave, resignation, or promotion during the study period.
Caregiver Exclusion Criteria:
* We will exclude those who 1) Report that no one smokes in the home; 2) Demonstrate an inability to understand their responsibilities as outlined in the consent form. This will be determined as the research staff verbally go through the consent form with the mothers. If mothers do not understand the consent form and subsequent procedures, they will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Smoke Free Home Rules (Questionnaire)
Timeframe: This outcome will be assessed at baseline.
2
Change in Smoke Free Home Rules (Questionnaire)
Timeframe: This outcome will be assessed at the 8 week time point.
3
Change in Smoke Free Home Rules (Questionnaire)
Timeframe: This outcome will be assessed at the 20 week time point.
4
Change in Smoke Free Home Rules (Questionnaire)
Timeframe: This outcome will be assessed at the 1 year time point.
5
Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
Timeframe: This outcome will be assessed at the 8-week time point.
6
Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
Timeframe: This outcome will be assessed at the 1 year time point.