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

NCT ID: NCT05000632

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2026-12-31

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.

Detailed Description

Longitudinal studies have found beneficial effects of prevention and intervention efforts for children exposed to poverty and other adverse experiences on long-term health and a range of social and psychological outcomes. Evidence-based intervention programs exist for smoke-free homes and for child maltreatment risk. However, to our knowledge, no programs jointly target SHS (secondhand smoke) exposure and maltreatment risk, despite the evidence that these risk factors often co-occur for children living in low-SES households.

Some Things are Better Outside (STBO) is a brief intervention that is highly effective in promoting adoption of smoke-free home rules among low-SES households. Three randomized controlled trials (RCTs) documented significant intervention effects, with 40.0 to 62.9% of clients reporting a smoke-free home when reached for follow-up at 6 months post-baseline. Self-reported smoke-free homes were validated by air nicotine at 3-months post-baseline. STBO was also effective in a dissemination trial conducted with five 2-1-1 agencies across multiple states. The six-week intervention was designed to be easy to deliver, consisting of three mailings of print materials and a 15-20 minute coaching call.

SafeCare is a brief parenting intervention that is highly effective in reducing child maltreatment perpetration and improving behavioral outcomes for Child Protective Services-involved (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). SafeCare is delivered in the home over 18-weeks, and the curriculum focuses on promotion of positive parenting skills, home safety, and child health. SafeCare is disseminated through the National SafeCare Training and Research Center (NSTRC) at Georgia State University (GSU), directed by Self-Brown (MPI) and Whitaker (Co-I).

In considering the best approaches for targeting SHS, it is imperative to consider how to integrate interventions with documented success for improving smoke-free rules and with high levels of parent engagement (which STBO has consistently demonstrated), into effective parenting intervention programs, such as SafeCare (which has also been demonstrated to be highly engaging). Thoughtful integration would ensure the maintenance of active ingredients for both programs, and parent engagement.

The goal of Smoke Free SafeCare is to conduct an effectiveness-implementation hybrid trial type 1 of the SFSC intervention for parents with substantiated maltreatment. This braided intervention will be compared to standard SafeCare.

The study aims are as follows:

1. To conduct an effectiveness-implementation hybrid trial type 1.

2. Compare SFSC to standard SafeCare on the addition of a full smoking ban in the home, and maintenance and stability of the smoking ban.

3. Understand impact and sustainability of SFSC on parenting outcomes.

4. Examine the variability in SFSC effects across sites and client characteristics.

This project will implement a mixed methods approach to gain insight about the perceived feasibility and impact of SFSC with mothers who report at least two risk factors at initial screening that are commensurate with child maltreatment perpetration risk. Understanding whether there is additive benefit to the integration of these programs will inform policy for best practices of programs serving low-SES families, and will further establish a structured approach for systematically integrating evidence-based programs for populations who have cumulative risk.

Conditions

Child Maltreatment; Smoking Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Smoke Free SafeCare

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Standard SafeCare

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SFSC; SafeCare

Eligibility Criteria

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.

Exclusion Criteria

• SafeCare providers will be excluded if they have planned for significant employment leave, resignation, or promotion during the study period.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Shannon Self-Brown

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon Self-Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Michelle Kegler

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Georgia State University

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Manderley Recinos

Role: CONTACT

mrecinos2@gsu.edu

(404) 413-1146

Shannon Self-Brown Principal Investigator

Role: CONTACT

sselfbrown@gsu.edu

4044133500

Facility Contacts

Manderley Recinos, MA

Role: primary

mrecinos2@gsu.edu

4044131146

Shannon Self-Brown, PhD

Role: backup

sselfbrown@gsu.edu

4044131283

References

Perry EW, Self-Brown S, Koontz K, Haardorfer R, Whitaker DJ, Spears CA, Huang J, Kegler M. Evaluating the effectiveness of Smoke-Free Home SafeCare, an integrated intervention, among families at risk for secondhand smoke exposure and child maltreatment in the United States: a study protocol for a hybrid type 1 trial. Trials. 2024 Oct 7;25(1):661. doi: 10.1186/s13063-024-08466-2.

Reference Type: DERIVED

PMID: 39375710 (View on PubMed)

Self-Brown S, Perry EW, Recinos M, Cotner MA, Guastaferro K, Owolabi S, Spears CA, Whitaker DJ, Huang J, Kegler MC. Systematic braiding of Smoke-Free Home SafeCare to address child maltreatment risk and secondhand smoke exposure: findings from a pilot study. Pilot Feasibility Stud. 2023 May 12;9(1):81. doi: 10.1186/s40814-023-01303-4.

Reference Type: DERIVED

PMID: 37173799 (View on PubMed)

Other Identifiers

H21543

Identifier Type: -

Identifier Source: org_study_id