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

NCT05000632 | Recruiting DMC

• 1 other identifier: H21543
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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

Smoking Behaviors; Child Maltreatment

Outcome Measures

Primary Outcomes (6)

• Smoke Free Home Rules (Questionnaire)

  Mothers will answer questions specific to smoke free home rules implemented in their home.

  This outcome will be assessed at baseline.

• Change in Smoke Free Home Rules (Questionnaire)

  Mothers will answer questions specific to smoke free home rules implemented in their home.

  This outcome will be assessed at the 8 week time point.

• Change in Smoke Free Home Rules (Questionnaire)

  Mothers will answer questions specific to smoke free home rules implemented in their home.

  This outcome will be assessed at the 20 week time point.

• Change in Smoke Free Home Rules (Questionnaire)

  Mothers will answer questions specific to smoke free home rules implemented in their home.

  This outcome will be assessed at the 1 year time point.

• Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation

  Research staff will place an air nicotine monitor in one room in which the family spends the most time. The monitors, the size of a petri dish, will be labeled and left in place for 7 days. For quality assurance and control, one blank sample per 10 samples will be included, along with duplicate samples collected for 10% of the total sample. Research staff will return to the home after 7 days to collect the monitor. Time-weighted average airborne nicotine will be assayed. The amount of nicotine collected is determined in the laboratory using gas chromatographic analysis. The sensitivity of these devices is sufficient to quantify low levels of passive smoke exposures over a period of a few days. Outcome is reported in micrograms of nicotine per cubed meter.

  This outcome will be assessed at the 8-week time point.

• Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation

  Research staff will place an air nicotine monitor in one room in which the family spends the most time. The monitors, the size of a petri dish, will be labeled and left in place for 7 days. For quality assurance and control, one blank sample per 10 samples will be included, along with duplicate samples collected for 10% of the total sample. Research staff will return to the home after 7 days to collect the monitor. Time-weighted average airborne nicotine will be assayed. The amount of nicotine collected is determined in the laboratory using gas chromatographic analysis. The sensitivity of these devices is sufficient to quantify low levels of passive smoke exposures over a period of a few days. Outcome is reported in micrograms of nicotine per cubed meter.

  This outcome will be assessed at the 1 year time point.

Secondary Outcomes (16)

• Parenting Young Children Survey (PYCS)

  Assessed at baseline

• Parenting Young Children Survey (PYCS)

  Assessed at 8-week

• Parenting Young Children Survey (PYCS)

  Assessed at 20-week

• Parenting Young Children Survey (PYCS)

  Assessed at 1 year

• Perceived Stress Scale

  Assessed at baseline

Other Outcomes (11)

• Demographic - Number of Children

  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.)

• Demographic - Employment Status

  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.)

• Demographic - Age

  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.)

Study Arms (2)

Smoke Free SafeCare (SFSC)

EXPERIMENTAL

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.

Behavioral: Smoke Free SafeCare

Standard SafeCare

ACTIVE COMPARATOR

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

Behavioral: Standard SafeCare

Interventions

Smoke Free SafeCare 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.

Also known as: SFSC

Smoke Free SafeCare (SFSC)

Standard SafeCare 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.

Also known as: SafeCare

Standard SafeCare

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgia State University: lead

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 39375710 DERIVED

• 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.

  PMID: 37173799 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shannon Self-Brown, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

• Michelle Kegler

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manderley Recinos

CONTACT

(404) 413-1146; mrecinos2@gsu.edu

Shannon Self-Brown Principal Investigator

CONTACT

4044133500; sselfbrown@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study personnel, including the PI and Co-Is (with the exception of methodologist) and assessment staff, will be masked to treatment condition until the database is locked. Limited staff will be unmasked to handle randomization codes, delivery support of interventions, and to complete reports.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized at the provider level. Provider participants will be randomized into either Smoke Free SafeCare or Standard SafeCare. Their arm designation will then determine the group that mother participants will be assigned to.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 11, 2021
• Study Start: April 19, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: IPD sharing will occur once the study is complete and will continue for up to two years after study completion.
• Access Criteria: Resource Sharing: This research will generate a dataset on parent and implementation outcomes for Smoke-Free SafeCare in child welfare settings in at least two states. If an investigator who is not part of our collaborative team requests these data, we will in turn request a research proposal that describes his/her research question, which variables/codes she/he would like to use, analysis plans, and proposed dissemination plans. Our investigator team will review and make decisions about these requests. Once we have completed our primary analyses, we will upload the de-identified quantitative datasets to an online data storage site, with accompanying documentation.

Locations

US (1)