Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorGeorgia State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Smoke Free SafeCare
BehavioralSFSC 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
BehavioralSafeCare 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.
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: Smoke Free SafeCare (SFSC)Experimental treatment 1 intervention
Group B: Standard SafeCareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Smoke Free Home Rules (Questionnaire)
Mothers will answer questions specific to smoke free home rules implemented in their home.
Time frame
This outcome will be assessed at baseline.2
Change in Smoke Free Home Rules (Questionnaire)
Mothers will answer questions specific to smoke free home rules implemented in their home.
Time frame
This outcome will be assessed at the 8 week time point.3
Change in Smoke Free Home Rules (Questionnaire)
Mothers will answer questions specific to smoke free home rules implemented in their home.
Time frame
This outcome will be assessed at the 20 week time point.4
Change in Smoke Free Home Rules (Questionnaire)
Mothers will answer questions specific to smoke free home rules implemented in their home.
Time frame
This outcome will be assessed at the 1 year time point.Secondary outcomes
1
Parenting Young Children Survey (PYCS)
Parenting behavior
Time frame
Assessed at baseline2
Parenting Young Children Survey (PYCS)
Parenting behavior
Time frame
Assessed at 8-week3
Parenting Young Children Survey (PYCS)
Parenting behavior
Time frame
Assessed at 20-week4
Parenting Young Children Survey (PYCS)
Parenting behavior
Time frame
Assessed at 1 yearOther outcomes
1
Demographic - Number of Children
Number of Children at the time of assessment
Time frame
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.)2
Demographic - Employment Status
Employment status at the time of assessment
Time frame
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.)3
Demographic - Age
Age at time of assessment
Time frame
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.)4
Demographic - Sex assigned at birth
Sex assigned at birth
Time frame
Assessed at baselineSponsors and contacts
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Source ClinicalTrials.gov