跳至主要内容
临床试验/NCT05000632
NCT05000632招募中不适用

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

Georgia State University1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2022年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
268
试验地点
1
主要终点
Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Study personnel, including the PI and Co-Is (with the exception of methodologist) and assessment staff, will be masked to treatment condition until the database is locked. Limited staff will be unmasked to handle randomization codes, delivery support of interventions, and to complete reports.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Standard SafeCare (Behavioral)

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.

干预措施: Smoke Free SafeCare (Behavioral)

结局指标

主要结局

Time-Weighted Average Airborne Nicotine - Smoke Free Home Validation

时间窗: 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

时间窗: 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.

Smoke Free Home Rules (Questionnaire)

时间窗: 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)

时间窗: 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.

Change in Smoke Free Home Rules (Questionnaire)

时间窗: 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)

时间窗: 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.

次要结局

  • Parenting Stress Inventory (PSI)(Assessed at 1 year)
  • Parenting Young Children Survey (PYCS)(Assessed at 1 year)
  • Perceived Stress Scale(Assessed at 1 year)
  • Smoking Cessation Questionnaire(Assessed at 1 year)
  • Parenting Young Children Survey (PYCS)(Assessed at baseline)
  • Parenting Young Children Survey (PYCS)(Assessed at 8-week)
  • Parenting Young Children Survey (PYCS)(Assessed at 20-week)
  • Perceived Stress Scale(Assessed at baseline)
  • Perceived Stress Scale(Assessed at 8 week)
  • Perceived Stress Scale(Assessed at 20 week)
  • Parenting Stress Inventory (PSI)(Assessed at baseline)
  • Parenting Stress Inventory (PSI)(Assessed at 8-week)
  • Parenting Stress Inventory (PSI)(Assessed at 20 week)
  • Smoking Cessation Questionnaire(Assessed at baseline)
  • Smoking Cessation Questionnaire(Assessed at 8-week)
  • Smoking Cessation Questionnaire(Assessed at 20-week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shannon Self-Brown

Professor

Georgia State University

研究点 (1)

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