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临床试验/NCT04656483
NCT04656483Unknown不适用

Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)

IRCCS National Neurological Institute "C. Mondino" Foundation2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
168
试验地点
2
主要终点
Maternal sensitivity

研究概览

简要总结

Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Early family-centered rehabilitation interventions are effective in promoting better infant outcomes and in optimizing healthcare systems economic return in the long-term. The Video Feedback intervention (VFI) is effective in promoting sensitive parenting and supporting infants' development. In the light of limited resources of the healthcare systems, technological advance in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness and efficacy of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

详细描述

Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Parents may report critical emotional burden with heightened risk for chronic levels of distress, depression and anxiety. This constitutes a crucial point considering that parenting represents the first preventive factors for infants' development also in the presence of ND conditions. Thus, it is not surprising that early rehabilitation interventions that focus on the parent-infant dyad have been found to be the most effective in recent meta-analytic study and to be the most rewarding for healthcare systems in terms of economic return in the long-term. Specifically, the VFI constitutes an early family-centered intervention that proved to be effective in promoting sensitive parenting and supporting infants' behavioral and socio-emotional development. The use of VFI intervention has been also documented to be beneficial in dyads of children with neurodevelopmental disability reducing child's disruptive and emotionally negative behaviors; promoting maternal sensitivity, increasing self- efficacy and reducing parenting stress. It should be highlighted that delivering VFI in hospital or home-based context should be highly demanding for the healthcare systems due to high cost and disparities in access to the service for families in remote areas. As such, delivering VFI through telemedicine approaches (e.g., videoconferencing) appears to hold promises of promoting a reduction in inequality of care, greater access to early family-centered support and a more effective and efficient promotion of health outcomes for infants with ND. We still do not know how a VFI support for parents of infants with ND may end up in being effective and efficient in terms of promoting infants' development and parental health. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

The SPHERE RCT will include two arms (see arm description) and three assessment phases: T0, baseline; T1, immediate post-intervention; T2, follow-up (6 months after the intervention). For both arms, standardized assessment sessions will include video-recording of mother-infant interaction and maternal self-report scales (depression [Beck Depression Inventory, BDI; Beck et al., 1961]; anxiety [State-Trait Anxiety Inventory, STAI-Y, Spielberg, 1983] parenting stress, [Parenting Stress Index, PSI; Abidin, 1983] and infants' temperament [Infant Behavior Questionnaire Revised, IBQ-R, Gartstein et al., 2003]).

研究设计

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

入排标准

年龄范围
1 Month 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infants' (corrected) age between 1 and 18 months;
  • presence of developmental risk or diagnosis of ND as defined by standardized clinical criteria;
  • parental age greater than 18 years;
  • parental mastery of Italian language;
  • parents living together with the infant.

排除标准

  • Infant's life-threatening conditions;
  • Maternal full-blown documented psychiatric disorders.

结局指标

主要结局

Maternal sensitivity

时间窗: Immediate post-intervention (6 weeks after the intervention started)

The maternal sensitivity will be coded through the Global Rating Scales (Murray, Fiori-Cowley, Hooper, \& Cooper, 1996). The score will range from 1 (low) to 5 (high).

次要结局

  • Infant emotional stress reactivity(Follow-up (6 months adfter the intervention ended))
  • Maternal sensitivity(Follow-up (6 months adfter the intervention ended))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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