Clinical trial NCT05000632: Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
Official title: Establishing Smoke-free Homes With Families Involved in Child Protective Services: Effectiveness-implementation Trial of an Integrated Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Maltreatment
Smoking Behaviors
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Smoke Free Home Rules (Questionnaire)
timeFrame: This outcome will be assessed at baseline.
measure: Change in Smoke Free Home Rules (Questionnaire)
timeFrame: This outcome will be assessed at the 8 week time point.
measure: Change in Smoke Free Home Rules (Questionnaire)
timeFrame: This outcome will be assessed at the 20 week time point.
measure: Change in Smoke Free Home Rules (Questionnaire)
timeFrame: This outcome will be assessed at the 1 year time point.
measure: Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
timeFrame: This outcome will be assessed at the 8-week time point.
measure: Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
timeFrame: This outcome will be assessed at the 1 year time point.
Secondary outcomes:
measure: Parenting Young Children Survey (PYCS)
timeFrame: Assessed at baseline
measure: Parenting Young Children Survey (PYCS)
timeFrame: Assessed at 8-week
measure: Parenting Young Children Survey (PYCS)
timeFrame: Assessed at 20-week
measure: Parenting Young Children Survey (PYCS)
timeFrame: Assessed at 1 year
measure: Perceived Stress Scale
timeFrame: Assessed at baseline
measure: Perceived Stress Scale
timeFrame: Assessed at 8 week
measure: Perceived Stress Scale
timeFrame: Assessed at 20 week
measure: Perceived Stress Scale
timeFrame: Assessed at 1 year
measure: Parenting Stress Inventory (PSI)
timeFrame: Assessed at baseline
measure: Parenting Stress Inventory (PSI)
timeFrame: Assessed at 8-week
measure: Parenting Stress Inventory (PSI)
timeFrame: Assessed at 20 week
measure: Parenting Stress Inventory (PSI)
timeFrame: Assessed at 1 year
measure: Smoking Cessation Questionnaire
timeFrame: Assessed at baseline
measure: Smoking Cessation Questionnaire
timeFrame: Assessed at 8-week
measure: Smoking Cessation Questionnaire
timeFrame: Assessed at 20-week
measure: Smoking Cessation Questionnaire
timeFrame: Assessed at 1 year
Other outcomes:
measure: Demographic - Number of Children
timeFrame: 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.)
measure: Demographic - Employment Status
timeFrame: 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.)
measure: Demographic - Age
timeFrame: 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.)
measure: Demographic - Sex assigned at birth
timeFrame: Assessed at baseline
measure: Demographic - Gender
timeFrame: Assessed at baseline
measure: Demographic - Race
timeFrame: Assessed at baseline
measure: Demographic - Ethnicity
timeFrame: Assessed at baseline
measure: Demographic - Relationship status
timeFrame: 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.)
measure: Demographic - Education
timeFrame: Assessed at baseline
measure: Demographic - Disability
timeFrame: 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.)
measure: Demographic - Household income
timeFrame: 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.)
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Shannon Self-Brown, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Michelle Kegler
role: PRINCIPAL_INVESTIGATOR
References: