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临床试验/NCT07153198
NCT07153198招募中不适用

Promoting Socioemotional Development in Early Childhood: Implementation and Evaluation of the VIPP-SD Parenting Intervention in Portugal

ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Parental sensitivity: Erickson Scales of Parental Sensitivity (ESPS, Egeland, et al., 1990)

研究概览

简要总结

The Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) is an attachment-based intervention aimed at promoting parental sensitivity and the use of developmentally appropriate, non-coercive discipline strategies (ref). The VIPP-SD intervention integrates the enhancement of parental sensitive responsiveness (Ainsworth et al., 1974) with parent coaching aimed at preventing coercive parent-child interaction cycles (Patterson, 1982) and facilitating sensitive limit-setting practices.ase parental sensitivity and sensitive discipline of the primary parent

详细描述

Aims and hypotheses

  1. The primary aim of the Growing Minds - Strengthening Affective Bonds is to demonstrate the effect of the VIPP-SD on parental sensitivity and sensitive discipline of the primary parent, 8 weeks after the intervention and six months after the intervention. It is expected that sensitivity and sensitive discipline of parents in the intervention condition will significantly increase post-intervention, compared to sensitivity and sensitive discipline of parents in the control condition, who have a similar number of ('dummy') contacts with the interveners.
  2. The secondary aim of the study is to examine the efficacy of the intervention in reducing children's behavioral problems, as a function of increased parental sensitivity and the use of sensitive discipline strategies. It is expected that improvements in parenting behaviors resulting from the VIPP-SD intervention will be associated with lower levels of behavioral difficulties in children over time.
  3. A third objective of the study is to evaluate the impact of the intervention on broader parenting practices and parental well-being, specifically aiming to mitigate psychopathological symptomatology. The focus will be on reducing symptoms of depression and anxiety among participating parents, in line with evidence suggesting that improvements in parenting sensitivity may contribute to enhanced parental mental health.
  4. Finally, the investigators will examine whether the intervention yields economic advantages for society at large. To do this, the investigators will use quality-adjusted life-years (QALYs) as the unit of outcome, allowing to quantify health benefits. By comparing the QALYs associated with the intervention to those resulting from no intervention, the investigators aim to assess the cost-effectiveness and potential return on investment from a societal perspective. This analysis will help determine whether the intervention not only improves family relations but also contributes to economic efficiency by potentially reducing healthcare costs, improving productivity, and enhancing overall societal well-being

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 (Participant)

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children will be between 2 and 6 years old, and their parents between must be fluent in Portuguese -

排除标准

  • Children with disabilities, chronic illnesses, or hereditary diseases will be excluded from the study

结局指标

主要结局

Parental sensitivity: Erickson Scales of Parental Sensitivity (ESPS, Egeland, et al., 1990)

时间窗: Data will be collected at pretest, posttest (14 weeks) .

Parental sensitivity will be assessed using the the revised Erickson 7-point rating scales for Supportive Presence (from 1 = parent completely fails to be supportive to the child to 7 = parent skilfully provides support throughout the session) and Intrusiveness (from 1 = parent allows the child sufficient time to explore and to attempt to solve tools on her/his own to 7 = parent is highly intrusive; her agenda clearly has precedence over the child's wishes; Egeland et al., 1990). Supportive presence is defined as the consistent emotional, physical, and psychological availability of a mother, characterized by both verbal expressions and nonverbal behaviors. High sensitivity is associated with positive developmental outcomes in children, including secure attachment and better emotional regulation. Intrusiveness reflects the extent to which a parent disregards or interferes with the child's autonomy, wishes, interests, or behaviors.

次要结局

  • Strengths & Difficulties Questionnaire" (SDQ Portuguese version Fleitlich et al., 2004)(Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).)
  • Depression, Anxiety, and Stress Scale - 21 (DASS-21)(Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).)
  • AQOL-8D (Richardson & Lezzi, 2014)(Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).)
  • Resource Use Characterization Questionnaire.(Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).)
  • Child Rearing Practices Report-Questionnaire (CRPR-Q)(Data will be collected at pretest, posttest (14 weeks) and follow up (12 weeks).)

研究者

发起方
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Manuela Pedro Veríssimo

Professor

ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

研究点 (1)

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