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临床试验/NCT05827952
NCT05827952已完成不适用

The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode in Caregivers With Toddler Receiving Early Intervention

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Intervention Fidelity

研究概览

简要总结

The past literature supports the use of digital media as a medium to provide ongoing interventions for families caring for children with difficulties and the opportunity to intervene directly through caregivers, and to combine the advantages of hybrid physical and online interventions, applying different modes of teaching and interacting, satisfying the need for high frequency supervision and feedback for habit building, responding to difficulties and adjusting settings appropriately and immediately, in addition to providing timely assistance, by In addition to providing timely assistance, by changing parents' behavioral patterns and skills, it can increase the caregiver's level of implementation, thus establishing subtle changes and learning in daily life, promoting the quality of interaction and relationship building, and therefore providing intervention.

The study aims to use the new specific model of behavior modification-"Atomic Habit" as the basis for behavior change intervention, combining parental self-identification and children's play participation to establish good thinking and behavior patterns of caregivers, to increase self-identification and reduce stress, and to improve relationships and reduce conflict.

详细描述

Background: The COVID-19 pandemic had reduced access to early care, education, and life participation for families of children with developmental delay, resulting in deterioration of parental mental health, child deterioration, and parental unemployment. The literature supports that face-to-face or online caregiver-mediated interventions could promote child development, self-efficacy and reduce parental stress. The clinical practice of early care center in our hospital lacked a multi-disciplinary integrated relationship facilitation program for caregivers of children with developmental delay.

Purpose: The purpose of this study is to investigate the effects and examine of the behavior modification by hybrid in Stress, self-efficacy, relationships and conflict for caregivers Method: Caregivers of development delay children were recruited and randomly assigned to "Hybrid group"(n=20), and " Self-learning group" (n=19). After 8-weeks training (Online sessions and individual consultation sessions), the performance was assessed by a blinded assessor. The outcome measures included Intervention Fidelity, Parenting Sense of Confidence, Parenting Stress Index: Short form, The Conflict Tactics Scales: Parent Version, habit schedule record, satisfaction questionnaire.

Date analyzing: Collected data will be analyzed with Mann-Whinney U test, the Wilcoxon Signed Ranked Test, and Spearman correlation analysis by SPSS version 20.0, and alpha level was set at 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • children currently receiving care in early care;
  • caregivers with a need to build parent-child relationships or improve self-efficacy;
  • those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
  • those with internet access..

排除标准

  • children currently receiving care in early care;
  • caregivers with a need to build parent-child relationships or improve self-efficacy;
  • those who were able to use the pilot process and complete the homework, completing at least 10/12 training;
  • those with internet access.

结局指标

主要结局

Intervention Fidelity

时间窗: through study completion, an average of 8 weeks

A 4-point scale was used to understand parents' performance in knowledge, practice, participation, time, and use of resources in the implementation of the curriculum. The scale is "1" for totally disagree, "2" for somewhat agree, "3" for mostly agree, and "4 " indicates full agreement.

Parenting Sense of Confidence

时间窗: Change from Baseline Parenting Sense of Confidence at 8 weeks

By assessing parents' confidence and satisfaction with their role as a parent, 17 questions were asked on a 6-point scale ranging from "1" for strong agreement to "6" for strong disagreement, with higher scores indicating higher levels of parental confidence. The higher the score, the higher the parent's confidence. The scale is divided into two components, PSOC-E and PSOC-S, which reflect parental frustration, anxiety, and motivation, respectively, and the latter reflects competence, problem solving, and ability to perform the role of a parent. The Parental Effectiveness Scale (PSOC-E), which measures overall parental effectiveness, has a good internal reliability (Cronbach's alpha) of 0.76, while the Parental Satisfaction Scale (PSOC-S) has a good internal reliability (Cronbach's alpha) of 0.75; and can be used with caregivers of children of all ages.

次要结局

  • The Conflict Tactics Scales: Parent Version(Change from Conflict Tactics Scales at 8 weeks)
  • Parenting Stress Index: Short form(Change from Parenting Stress at 8 weeks)
  • Satisfaction Questionnaire:(through study completion, an average of 8 weeks)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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