Child MaltreatmentSFSCNCT05000632
Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
A study testing Smoke Free SafeCare and Standard SafeCare in people with Child Maltreatment and Smoking Behaviors, run by Georgia State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Smoking Behaviors
- What is being tested?
- Smoke Free SafeCare and Standard SafeCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgia State University
Atlanta, Georgia, 30302
Manderley Recinos, MA, 4044131146, mrecinos2@gsu.edu
Shannon Self-Brown, PhD, 4044131283, sselfbrown@gsu.edu
About this study
Official title: Establishing Smoke-free Homes With Families Involved in Child Protective Services: Effectiveness-implementation Trial of an Integrated Program
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.
Read the 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:
- To conduct an effectiveness-implementation hybrid trial type 1.
- Compare SFSC to standard SafeCare on the addition of a full smoking ban in the home, and maintenance and stability of the smoking ban.
- Understand impact and sustainability of SFSC on parenting outcomes.
- 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.
- Conditions
- Child Maltreatment, Smoking Behaviors
- Being tested
- Smoke Free SafeCare, Standard SafeCare
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke Free SafeCareBehavioural
Also called SFSC
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 SafeCareBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard SafeCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoke Free Home Rules (Questionnaire)
Mothers will answer questions specific to smoke free home rules implemented in their home.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome will be assessed at the 1 year time point.
Secondary outcomes (16)
Parenting Young Children Survey (PYCS)
Parenting behavior
Measured: Assessed at baseline
Parenting Young Children Survey (PYCS)
Parenting behavior
Measured: Assessed at 8-week
Parenting Young Children Survey (PYCS)
Parenting behavior
Measured: Assessed at 20-week
Parenting Young Children Survey (PYCS)
Parenting behavior
Measured: Assessed at 1 year
Perceived Stress Scale
Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress
Measured: Assessed at baseline
Perceived Stress Scale
Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress
Measured: Assessed at 8 week
Perceived Stress Scale
Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress
Measured: Assessed at 20 week
Perceived Stress Scale
Measure of personal stress; Min: 0, Max: 5; Higher scores indicated higher perceived stress
Measured: Assessed at 1 year
Parenting Stress Inventory (PSI)
Parent stress
Measured: Assessed at baseline
Parenting Stress Inventory (PSI)
Parent stress
Measured: Assessed at 8-week
Parenting Stress Inventory (PSI)
Parent stress
Measured: Assessed at 20 week
Parenting Stress Inventory (PSI)
Parent stress
Measured: Assessed at 1 year
Smoking Cessation Questionnaire
These questions assess parents attempts to stop or minimize smoking behaviors
Measured: Assessed at baseline
Smoking Cessation Questionnaire
These questions assess parents attempts to stop or minimize smoking behaviors
Measured: Assessed at 8-week
Smoking Cessation Questionnaire
These questions assess parents attempts to stop or minimize smoking behaviors
Measured: Assessed at 20-week
Smoking Cessation Questionnaire
These questions assess parents attempts to stop or minimize smoking behaviors
Measured: Assessed at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start19 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Self-Brown, Georgia State University
- Investigators
- Shannon Self-Brown, PhD, Principal investigator, Georgia State UniversityMichelle Kegler, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000632
- Sponsor's protocol ID
- H21543
- Acronym
- SFSC
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data related to a dataset on parent and implementation outcomes have the potential to be shared with other researchers, if requested.
Publications
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.
PubMed 39375710Self-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.
PubMed 37173799
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Smoke-free Homes With Families Involved in Child Protective Services: Effectiveness-implementation Trial of an Integrated Program
- ClinicalTrials.gov ID
- NCT05000632
- Acronym / sponsor ID
- SFSC / H21543
- Conditions
- Child Maltreatment, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To conduct an effectiveness-implementation hybrid trial type 1.
- Compare SFSC to standard SafeCare on the addition of a full smoking ban in the home, and maintenance and stability of the smoking ban.
- Understand impact and sustainability of SFSC on parenting outcomes.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smoke Free SafeCare (SFSC) | Experimental | Behavioral: Smoke Free SafeCareProviders 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 | Active comparator | Behavioral: Standard SafeCareProviders randomized to this group will disseminate the Standard SafeCare program to families who report having a smoker in the home. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoke Free SafeCareAlso: SFSCSFSC 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. | Behavioural | Smoke Free SafeCare (SFSC) |
| Standard SafeCareAlso: SafeCareSafeCare 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. | Behavioural | Standard SafeCare |
Primary outcome
Smoke Free Home Rules (Questionnaire)
Time frame: This outcome will be assessed at baseline.
Mothers will answer questions specific to smoke free home rules implemented in their home.
Change in Smoke Free Home Rules (Questionnaire)
Time frame: This outcome will be assessed at the 8 week time point.
Mothers will answer questions specific to smoke free home rules implemented in their home.
Change in Smoke Free Home Rules (Questionnaire)
Time frame: This outcome will be assessed at the 20 week time point.
Mothers will answer questions specific to smoke free home rules implemented in their home.
Change in Smoke Free Home Rules (Questionnaire)
Time frame: This outcome will be assessed at the 1 year time point.
Mothers will answer questions specific to smoke free home rules implemented in their home.
Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
Time frame: This outcome will be assessed at the 8-week time point.
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.
Change in Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation
Time frame: This outcome will be assessed at the 1 year time point.
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.
16 secondary outcomes
Parenting Young Children Survey (PYCS)
Time frame: Assessed at baseline
Parenting Young Children Survey (PYCS)
Time frame: Assessed at 8-week
Parenting Young Children Survey (PYCS)
Time frame: Assessed at 20-week
Parenting Young Children Survey (PYCS)
Time frame: Assessed at 1 year
Perceived Stress Scale
Time frame: Assessed at baseline
Perceived Stress Scale
Time frame: Assessed at 8 week
Perceived Stress Scale
Time frame: Assessed at 20 week
Perceived Stress Scale
Time frame: Assessed at 1 year
Parenting Stress Inventory (PSI)
Time frame: Assessed at baseline
Parenting Stress Inventory (PSI)
Time frame: Assessed at 8-week
Parenting Stress Inventory (PSI)
Time frame: Assessed at 20 week
Parenting Stress Inventory (PSI)
Time frame: Assessed at 1 year
Smoking Cessation Questionnaire
Time frame: Assessed at baseline
Smoking Cessation Questionnaire
Time frame: Assessed at 8-week
Smoking Cessation Questionnaire
Time frame: Assessed at 20-week
Smoking Cessation Questionnaire
Time frame: Assessed at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 39375710Perry 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.
- Derived from this study: PubMed 37173799Self-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.
- Individual participant dataSharing planned: Yes. All collected individual participant data related to a dataset on parent and implementation outcomes have the potential to be shared with other researchers, if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Self-Brown, PhD principal investigator
Georgia State University
Michelle Kegler principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke Free SafeCare and Standard SafeCare in people with Child Maltreatment and Smoking Behaviors, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manderley Recinos ((404) 413-1146, mrecinos2@gsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoke Free Home Rules (Questionnaire) (time frame: This outcome will be assessed at baseline.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.