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

Smoking Behaviors Clinical Trial

— SFSC  

Official title:

Establishing Smoke-free Homes With Families Involved in Child Protective Services: Effectiveness-implementation Trial of an Integrated Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000632
• Other study ID #: H21543
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Georgia State University
• Contact: Michaela Cotner Research Associate
• Phone: (404) 413-1146
• Email: mcotner[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Maltreatment
• Smoking Behaviors

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic - Number of Children	Number of Children at the time of assessment	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.)
Other	Demographic - Employment Status	Employment status at the time of assessment	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.)
Other	Demographic - Age	Age at time of assessment	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.)
Other	Demographic - Sex assigned at birth	Sex assigned at birth	Assessed at baseline
Other	Demographic - Gender	Gender	Assessed at baseline
Other	Demographic - Race	Race	Assessed at baseline
Other	Demographic - Ethnicity	Ethnicity	Assessed at baseline
Other	Demographic - Relationship status	Relationship status at time of assessment	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.)
Other	Demographic - Education	Highest grade/level completed in school	Assessed at baseline
Other	Demographic - Disability	Supported by disability at time of assessment	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.)
Other	Demographic - Household income	Household income at time of assessment	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.)
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Parenting Young Children Survey (PYCS)	Parenting behavior	Assessed at baseline
Secondary	Parenting Young Children Survey (PYCS)	Parenting behavior	Assessed at 8-week
Secondary	Parenting Young Children Survey (PYCS)	Parenting behavior	Assessed at 20-week
Secondary	Parenting Young Children Survey (PYCS)	Parenting behavior	Assessed at 1 year
Secondary	Perceived Stress Scale	Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress	Assessed at baseline
Secondary	Perceived Stress Scale	Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress	Assessed at 8 week
Secondary	Perceived Stress Scale	Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress	Assessed at 20 week
Secondary	Perceived Stress Scale	Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress	Assessed at 1 year
Secondary	Parenting Stress Inventory (PSI)	Parent stress	Assessed at baseline
Secondary	Parenting Stress Inventory (PSI)	Parent stress	Assessed at 8-week
Secondary	Parenting Stress Inventory (PSI)	Parent stress	Assessed at 20 week
Secondary	Parenting Stress Inventory (PSI)	Parent stress	Assessed at 1 year
Secondary	Smoking Cessation Questionnaire	These questions assess parents attempts to stop or minimize smoking behaviors	Assessed at baseline
Secondary	Smoking Cessation Questionnaire	These questions assess parents attempts to stop or minimize smoking behaviors	Assessed at 8-week
Secondary	Smoking Cessation Questionnaire	These questions assess parents attempts to stop or minimize smoking behaviors	Assessed at 20-week
Secondary	Smoking Cessation Questionnaire	These questions assess parents attempts to stop or minimize smoking behaviors	Assessed at 1 year