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临床试验/NCT07417930
NCT07417930招募中不适用

Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation

Klein Buendel, Inc.1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2026年7月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
516
试验地点
1
主要终点
Child-Parent Relationship Scale-Short Form (CPRS-SF)

研究概览

简要总结

The goal of this study is to evaluate the effects of the hybrid ezParent program (e.g., web-based training program plus synchronous group sessions) on parent and child outcomes in a community setting serving parents of children 2-5 years old. Parent participants will complete surveys at baseline, and 10 and 24-weeks post baseline.

详细描述

Positive parenting practices (e.g., supportive, consistent, responsive) buffer the negative effects of early adverse experiences by developing safe, stable, and nurturing environments. Positive parenting practices are important in strengthening and creating positive childhood and supporting optimal child social and behavioral development. Parent training (PT) is the gold standard for supporting and strengthening parenting practices and preventing and treating child behavior problems. The PT program proposed in this study is the web-based adaptation of the evidence-based based Chicago Parent Program (CPP), called ezParent. The purpose of this study is to test the effects of hybrid delivery of ezParent versus a waitlist control on parent and child outcomes. Hybrid ezParent combines the self-administered ezParent with virtual or in-person group meetings. Hybrid ezParent lasts ~ 8 weeks and includes four 1-1.5 hour group sessions led by trained facilitators, held via Zoom or in person. Facilitators follow a discussion guide to reinforce content, build community, and support program use.

A cluster-randomized trial will be conducted with 16 organizations (sites) randomized to either the intervention (hybrid ezParent) or control condition (waitlist control). There will be 8 sites per condition. Each site will recruit approximately 32 parents of children aged 2-5 years, for a total sample size of approximately 516 parents. All participating parents within a given site will receive the condition assigned to that site. Once sites are randomized to intervention or waitlist control, parents are invited to participate through recruitment materials. Outcome data will be collected from parents at 3 timepoints over 6 months at baseline, and 10 and 24- weeks post-baseline. Outcome data includes parenting skills and self-efficacy, parent-child relationship, and reductions in child behavior problems.

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
None

入排标准

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

入选标准

  • Parent or legal guardian of a 2-5-year-old child receiving services at the partnering organization site.
  • Speaks English or Spanish.
  • Has a smartphone, tablet, or computer with Wi-Fi access to receive the ezParent program.

排除标准

  • Parents who have previously participated in CPP or ezParent will be excluded.

研究组 & 干预措施

Control

No Intervention

Participants receive usual services for parents and families at their agency during the study period.

Hybrid ezParent Intervention

Experimental

Hybrid ezParent includes the web-based ezParent program and 4 synchronous group sessions. ezParent is a 6-module digital delivery of the group-based Chicago Parent Program (CPP). The purpose of the program is to strengthen parenting, decrease child behavior problems, and increase child prosocial behavior. Each module includes: a video narrator describing parenting strategies; video vignettes of parents and children as examples of how parenting strategies work; questions following each vignette for parents to reflect upon; interactive activities for parents to complete; knowledge questions to assess parent understanding of the strategies; and practice assignments. Parents are instructed to complete modules independently between synchronous group sessions.

Group sessions are 1-1.5 hours and follow a discussion guide to reinforce key content, build community, and support parents in using ezParent. Trained facilitators lead groups of about 10 parents either in-person or virtual.

干预措施: ezParent (Behavioral)

结局指标

主要结局

Child-Parent Relationship Scale-Short Form (CPRS-SF)

时间窗: Baseline, 10- and 24-weeks post-baseline

The CPRS-SF has 15 items that parents rate their perception of their relationship with their child. The measure taps into positive and negative aspects of parent-child relationships. The CPRS-SF is rated on a 5-point scale with two subscales of closeness and conflict. Possible range= 0-35

Parenting Sense of Competence Scale (PSOC)

时间窗: Baseline, 10- and 24-weeks post-baseline

The Parenting Sense of Competence Scale (PSOC) has 17 items, with 2 subscales: satisfaction (person's liking of the parenting role) and efficacy (person's perceived competence in the parenting role). Scale: 6-point Likert scale (1 = strongly disagree, 6 = strongly agree) Minimum item score = 1 Maximum item score = 6 Subscale scoring (satisfaction and efficacy): Higher scores means a better outcome

Strengths and Difficulties Questionnaire (SDQ)

时间窗: Baseline, 10- and 24-weeks post-baseline

The Strengths and Difficulties Questionnaire (SDQ) is 25-items with five subscales: emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. A total difficulties score (TDS) is generated from the emotional, conduct, hyperactivity- inattention, and peer problems scales. Scale: 3-point scale (not true, somewhat true, and certainly true). Minimum item score = 0 Maximum item score = 2 Minimum subscale score = 0 Maximum subscale score = 10 Subscale scoring - Prosocial subscale: Higher score means a better outcome All other subscales (emotional, conduct, hyperactivity, peer): Higher scores means a worse outcome

Multidimensional Assessment of Parenting Scale (MAPS) Parent-form - Version 2.0

时间窗: Baseline, 10- and 24-weeks post-baseline

A 35-item scale measures parenting practices constituting both positive and negative dimensions of warmth/hostility and behavioral control appropriate for parents of children across the developmental span from young childhood through adolescence. Parents respond to each item on a 5-point scale from "Never" to "Always". Possible range= 0-175

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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