Smoke Free SafeCare for Smoking Behaviors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Georgia State University, Atlanta, GA
Smoking Behaviors+1 More
Smoke Free SafeCare - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can reduce secondhand smoke exposure in homes.

See full description

Eligible Conditions

  • Smoking Behaviors
  • Maltreatment, Child

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Smoke Free SafeCare will improve 4 primary outcomes, 5 secondary outcomes, and 11 other outcomes in patients with Smoking Behaviors. Measurement will happen over the course of Assessed at baseline.

Assessed at 1 year
Devereux Early Childhood Assessment (DECA)
Parenting Stress Inventory (PSI)
Parenting Young Children Survey (PYCS)
Perceived Stress Scale
Smoking Cessation Questionnaire
Assessed at baseline
Demographic - Education
Demographic - Ethnicity
Demographic - Gender
Demographic - Race
Demographic - Sex assigned at birth
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
Demographic - Disability
Demographic - Employment Status
Demographic - Household income
Demographic - Number of Children
Demographic - Relationship status
This outcome will be assessed at baseline.
Smoke Free Home Rules (Questionnaire)
Year 1
Change in Smoke Free Home Rules (Questionnaire)
Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
This outcome will be assessed at the 8-week time point.
Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Standard SafeCare
1 of 2
Smoke Free SafeCare (SFSC)
1 of 2
Active Control
Experimental Treatment

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Smoke Free SafeCare is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Smoke Free SafeCare (SFSC)
Behavioral
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.
Standard SafeCare
Behavioral
Providers randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.) for reporting.

Who is running the study

Principal Investigator
S. S.
Prof. Shannon Self-Brown, Professor
Georgia State University

Closest Location

Georgia State University - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Mothers in this study must meet the following inclusion criteria to participate: 1) Mother referred to a SafeCare Provider study participant as the result of a child protection case; 2) Mother reports in-home smoking behavior by herself or another person (person must reside in the home 3 or more nights a week) 3) Mother must be aged 18 or older and 4) must be a parent to a child between the ages of 0 and 5.
Provider

Patient Q&A Section

What are the signs of maltreatment, child?

"Severe physical abuse or neglect are evident in 20% of these cases. The signs were found in one case of severe sexual abuse. As these are subtle signs, it has been suggested that most parents with a history of severe maltreatment would not recognise these signs as signs of abuse. Further studies are required to establish this point of confidence. We also found that a history of maltreatment is associated with developmental delays and delayed development. These include difficulties with social and emotional development, speaking and hearing and coordination. These are the key signs associated with children being abused. Further understanding of the signs may help clinicians to identify cases of abuse and, with better methods of diagnosis, may allow earlier intervention to avert these tragic consequences." - Anonymous Online Contributor

Unverified Answer

What are common treatments for maltreatment, child?

"The treatment in maltreated children varies depending on the kind of maltreatment they have experienced. Treatment is often limited and focuses only on short-term effects in cases of neglect. Child Protective Services may respond to child abuse with short-term supportive treatment that often focuses on attachment issues, developmental delays, and social issues. Child Protective Services may also respond to child maltreatment by providing permanent supportive treatment to help the family work through trauma, which will help the child grow into a healthy, resilient adult. Finally, child Protective Services may also work to ensure that children have access to comprehensive care with an emphasis on the protection of children regardless of their socioeconomic status." - Anonymous Online Contributor

Unverified Answer

Can maltreatment, child be cured?

"The main complaint of clients attending this service was persistent sexual urges, followed by a desire for elimination and to be cured of these urges. The most common form of elimination tried was injecting solutions of cocaine or amphetamines, which were the most used illicit drugs." - Anonymous Online Contributor

Unverified Answer

How many people get maltreatment, child a year in the United States?

"More than 4 million US children experience maltreatment. As treatment for children, it is important to be aware of the prevalence of maltreatment and to ensure that the child receives needed care. The fact that only about half of the surveyed children received treatment reflects the need for a broader network of child protection agencies and for more extensive training in evidence-based preventive services." - Anonymous Online Contributor

Unverified Answer

What causes maltreatment, child?

"The risk of child maltreatment is a combination of genetics, prenatal, perinatal, postnatal, and childhood risk factors. Genetic risk factors contribute to a significant proportion of risk of child maltreatment in most societies." - Anonymous Online Contributor

Unverified Answer

What is maltreatment, child?

"Maltreatment, child may be defined as being neglected, abused or beaten by either or both parents. It was common for children and especially boys to be involved in maltreatment in the home and to participate in other forms of maltreatment, mainly sexual abuse." - Anonymous Online Contributor

Unverified Answer

Does smoke free safecare improve quality of life for those with maltreatment, child?

"We developed smoke-free safecare programmes with smokers being offered these alternatives. These programmes improved quality of life in individuals with maltreatment, child. This was associated with a lower smoking status and with reduced medical comorbidity." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in smoke free safecare for therapeutic use?

"More progress has been made in the last ten years toward tobacco control and smoking protection. Although more harm can be done by inhalation than by smoke, the progress is worthwhile because of the potential for smoking to be reduced. The WHO Framework Convention on Tobacco Control includes health in its goal of reducing tobacco use. In developing countries, smokeless tobacco use is common. In certain parts of the world, the use of tobacco is [the dominant form of tobacco use] that is not completely smoke free. In industrialized countries, there is a substantial reduction in the use of other types of tobacco." - Anonymous Online Contributor

Unverified Answer

Does maltreatment, child run in families?

"Findings from a recent study suggest that, in general, family abuse and neglect are associated with both the occurrence and severity of emotional disturbances in adulthood." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving smoke free safecare?

"Safecare clinics encourage the use of smoke free spaces for clients arriving for treatment. We observed reduced exposure to secondhand smoke at all venues analysed." - Anonymous Online Contributor

Unverified Answer

Has smoke free safecare proven to be more effective than a placebo?

"Safefacare has reduced the overall prevalence of dental disease by around 10 percent to 21 per cent (and by almost 4 percent in children), compared to the prevalence in the controls. Safefacare was found to be more effective than a control in reducing the progression of untreated caries into severe dental decay in all the age groups and in children. The findings from the present review suggest that the intervention has significantly more profound and long term impacts on the oral health of the population as a whole instead of simply having a short-term effect of a few minutes a day." - Anonymous Online Contributor

Unverified Answer

How serious can maltreatment, child be?

"In a recent study, findings add further evidence that child abuse/neglect is highly associated with adverse outcomes in adult psychopathology. In a recent study, findings support the development of specific and effective programs to prepare child abusers/neglecters to improve their psychological adjustment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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