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Recruiting NCT05000632

NCT05000632 Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families

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Clinical Trial Summary
NCT ID NCT05000632
Status Recruiting
Phase
Sponsor Georgia State University
Condition Child Maltreatment
Study Type INTERVENTIONAL
Enrollment 268 participants
Start Date 2022-04-19
Primary Completion 2026-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 89 Years
Study Type INTERVENTIONAL
Interventions
Smoke Free SafeCareStandard SafeCare

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 268 participants in total. It began in 2022-04-19 with a primary completion date of 2026-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Manderley Recinos

✉ mrecinos2@gsu.edu

📞 (404) 413-1146

Principal Investigator

Shannon Self-Brown, PhD

PRINCIPAL INVESTIGATOR

Georgia State University

Frequently Asked Questions

Who can join the NCT05000632 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Child Maltreatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05000632 currently recruiting?

Yes, NCT05000632 is actively recruiting participants. Contact the research team at mrecinos2@gsu.edu for enrollment information.

Where is the NCT05000632 trial being conducted?

This trial is being conducted at Atlanta, United States.

Who is sponsoring the NCT05000632 clinical trial?

NCT05000632 is sponsored by Georgia State University. The principal investigator is Shannon Self-Brown, PhD at Georgia State University. The trial plans to enroll 268 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology