CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all using a pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings. The trial will enroll 300 families in Ontario, Canada. The evaluation is informed by the RE-AIM framework, with a primary emphasis on Reach and Implementation and secondary examination of Effectiveness, consistent with the objectives of a Hybrid Type II design.
详细描述
The overall goal of the evaluation is to assess the extent to which the target population is reached and retained in FCU+ within routine service settings. Reach will be evaluated through recruitment rates (the proportion of eligible families who consent and enroll), retention (the proportion of randomized participants completing follow-up assessments), and family-level uptake of FCU+ intervention components. Second, we aim to provide robust evidence about the implementation and effectiveness of the Family Check-Up program, in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes. The investigators will conduct a ua pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings with 300 participating caregivers to compare the Family Check-Up (FCU) to treatment as usual (TAU) . Participants will be randomly assigned to one of the two conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the FCU participants will begin their sessions and the TAU participants will receive a different program, or short therapy sessions. Caregivers will complete a baseline research assessment and follow-up assessments at 6- and 12-months.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Custodial caregiver of child is aged 2 to 6 years at time of screening.
- •Families with sufficient knowledge of English needed for assessment measures.
- •Caregivers capable of giving informed, written consent.
- •Definition of 'at-risk' as measured by (a) or (b)as outlined below:
- •parental mental health problems, as indexed by a score of ≥ 13 on the K6 distress scale or; (b) Meeting pre-determined criteria for higher risk, for example, a family may be eligible for FCU if any one or more of the following are present based on the Family Needs Assessment : i) child behaviour or school-related concerns; ii) parenting difficulty or low parenting confidence; iii) Substance use causing family-level problems; or iv) three or more social or material stressors affecting parenting
排除标准
- •Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent
研究组 & 干预措施
Family Check Up +
Caregivers randomized to this arm (n=1500) will receive the Family Check-Up Program
干预措施: Family Check Up (Behavioral)
Treatment as Usual
Caregivers randomized to this arm (n=150) will receive either a different program, or brief services
干预措施: Family Check Up (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: During recruitment - pre-randomization
Description: As part of the reach assessment of the RE-AIM domain, We will assess the extent to which the target population is reached in FCU. Recruitment will be assessed as the proportion of eligible families who consent and enroll in the study following screening for FCU+ eligibility. Unit of Measure: Proportion (%) of eligible families enrolled. Recruitment will be interpreted using a traffic-light approach (green = feasible; amber = feasible with modification; red = not feasible without substantial redesign), which is commonly used in pilot trials to support transparent decision-making regarding progression. Recruitment feasibility will be assessed based on the proportion of eligible families who consent and enroll: * Green: ≥60% of eligible families approached enroll * Amber: 40-59% enroll * Red: \<40% enroll Data Source: Study screening logs and REDCap enrollment records
Fidelity to FCU Delivery
时间窗: During Intervention- on average 3-5 weeks
Description: Fidelity to FCU delivery within routine services will be assessed for the core FCU components (initial interview, assessment, and feedback) using the COACH observational rating system. Sessions will be securely video-recorded and coded by trained raters. Unit of Measure: Mean COACH fidelity score and proportion (%) of sessions meeting predefined fidelity thresholds. The COACH assesses five dimensions of observable in-session coordinator skills: conceptual accuracy; responsiveness to family context and needs; active session structuring; effective teaching and corrective feedback; and generation of hope and motivation. Each dimension includes exemplars and non-exemplars and is rated on a 9-point scale reflecting competent adherence to the program (1-3 = needs work; 4-6 = competent work; 7-9 = excellent work), with higher scores indicating stronger mastery of FCU principles Data Source: Coded video-recorded sessions and fidelity rating forms
Engagement in Everyday Parenting (EDP) Sessions
时间窗: During Intervention- on average 6 sessions
Description: Among participants for whom parenting support is indicated, engagement will be assessed by participation in at least one EDP session. Unit of Measure: Proportion (%) of indicated participants attending EDP sessions using means, medians, and relevant quantiles. Data Source: Intervention delivery logs
Retention
时间窗: 3, 6, 9, and 12 months post-randomization
Description: Retention will be assessed as the proportion of randomized participants who complete follow-up assessments at each scheduled time point. Retention performance will be interpreted using a traffic-light approach (green = feasible; amber = feasible with modification; red = not feasible without substantial redesign). Retention feasibility will be assessed based on completion of follow-up assessments: * Main follow-ups (6 and 12 months): * Green: ≥80% retained at 6 months and ≥75% retained at 12 months * Amber: 70-79% retained at 6 months and/or 65-74% retained at 12 months * Red: \<70% retained at 6 months or \<65% retained at 12 months * Short follow-ups (3 and 9 months): * Green: ≥75% completion * Amber: 65-74% completion * Red: \<65% completion retained at 12 months: * Green: ≥75% provide complete parenting and child outcome measures * Amber: 65-74% complete data * Red: \<65% complete data Data Source: REDCap follow-up records
Completion of Core FCU Components
时间窗: During Intervention - on average 3-5 weeks
Description: Within the intervention arm, uptake of core FCU components will be assessed by completion of the assessment and feedback sessions. Unit of Measure: Proportion (%) of intervention participants completing core FCU components using means, medians, and relevant quantiles. Data Source: Structured intervention delivery logs
Receipt of Navigation and Linkage Activities
时间窗: During Intervention- Up to 1 year
Description: Among participants for whom service navigation is indicated, uptake will be assessed by receipt of navigation and linkage activities. Unit of Measure: Proportion (%) of indicated participants receiving navigation services Data Source: Intervention delivery logs
Dose of FCU Services Delivered
时间窗: During entire study period- up to 12 months
Description: Dose of FCU delivery within routine services will be assessed using routine service records documenting completion of FCU components, parenting support sessions, and navigation and linkage activities, when indicated. Unit of Measure: Number and proportion (%) of completed FCU-related service components Data Source: Routine service records and de-identified monthly provider logs
Timeliness of FCU Delivery
时间窗: Time of intervention- on average 3-5 weeks
Description: Timeliness of FCU delivery within routine services will be assessed as the elapsed time from randomization to completion of the FCU assessment and feedback. Unit of Measure: Time (days) in intervention using means, medians, and relevant quantiles. Data Source: REDCap enrollment records and intervention delivery logs
次要结局
- Child emotional/behavioural problems(Baseline, 6-months, 12 months)
- Parenting Practices(Baseline, 6 months, 12 months)
研究者
Andrea Gonzalez (for Nathan)
Associate Professor
McMaster University