Recruiting

Observational Study

Sponsor:

Georgia State University

Code:

NCT05000632

Conditions

Child Maltreatment

Smoking Behaviors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Smoke Free SafeCare

Standard SafeCare

Study Details

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.

Conditions

Child Maltreatment

Smoking Behaviors

Study ID

NCT05000632

Start date

Apr 19, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

268 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Smoke Free SafeCare (SFSC)

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.

active comparator: Standard SafeCare

Providers randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home.

Interventions

Smoke Free SafeCare

SFSC is the systematically braided curriculum which combines both SafeCare and STBO programs, but in a new delivery format. To take full advantage of the home delivery mechanism of SafeCare, the content delivery of STBO has been adapted so that original mailings will be delivered in the SafeCare sessions. STBO has been fully braided into the Health and Safety modules. One of these interventions will be delivered first throughout the course of the study. The Smoke Free SafeCare intervention will involve 25 providers receiving training for the SFSC program. They will each recruit 10 mothers and conduct the SFSC program for each family. Overall, 250 families will receive the SFSC intervention.

Standard SafeCare

SafeCare is a brief parenting intervention that is highly effective in reducing child maltreatment perpetration and improving behavioral outcomes for CPS-involved parents of young children (0 to 5 years) as the result of child physical abuse or neglect (the two most common forms of substantiated maltreatment). The Standard SafeCare intervention will involve 25 SafeCare providers delivering the SafeCare program as usual. They will each recruit 10 mothers and conduct SafeCare for each family. Overall, 250 families will receive the standard SafeCare.

Primary outcome measure

  • Smoke Free Home Rules (Questionnaire) [ Time Frame: This outcome will be assessed at baseline. ]
  • Change in Smoke Free Home Rules (Questionnaire) [ Time Frame: This outcome will be assessed at the 8 week time point. ]
  • Change in Smoke Free Home Rules (Questionnaire) [ Time Frame: This outcome will be assessed at the 20 week time point. ]
  • Change in Smoke Free Home Rules (Questionnaire) [ Time Frame: This outcome will be assessed at the 1 year time point. ]
  • Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation [ Time Frame: This outcome will be assessed at the 8-week time point. ]
  • Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation [ Time Frame: This outcome will be assessed at the 1 year time point. ]

Central Contacts and Locations

Central contacts

Manderley Recinos

(404) 413-1146mrecinos2@gsu.edu

Shannon Self-Brown Principal Investigator

4044133500sselfbrown@gsu.edu

Locations

Georgia State University

Recruiting

Atlanta, Georgia, United States, 30302

Contacts

Manderley Recinos, MA

4044131146mrecinos2@gsu.edu

Shannon Self-Brown, PhD

4044131283sselfbrown@gsu.edu

Principal Investigator:

Shannon Self-Brown, PhD

More Information

Sponsor

Georgia State University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia State University on 2026-04-24.