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临床试验/NCT06155162
NCT06155162已完成不适用

Efficacy of Parent-delivered HuggyPuppy Intervention for Reducing War-related Distress in Young Children

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Stress reactions

研究概览

简要总结

This clinical trial will test the efficacy of parent-delivered HuggyPuppy Intervention in alleviating war-related stress in children aged 3-8 during the Gaza-Israel war. Moreover, it will test whether the type of doll provided moderates the efficacy of the intervention. Children will be provided a doll ('Huggy') of to their homes or places of shelter, and asked to take care of it. Five different types of dolls will be randomly assigned to children. Pre-intervention, parents will complete a brief questionnaire asking about the child's past week stress symptoms, and exposure to traumatic war-experiences. Three weeks following the intervention, parents will be asked to complete a post-intervention questionnaire, asking about the child's symptoms, their own anxiety, depression, and stress, as well as their use of the intervention.

详细描述

The goal of this clinical trial is to test the efficacy of parent-delivered HuggyPuppy Intervention in alleviating war-related stress in children aged 3-8 during the Gaza-Israel war. The trial also aims to examine whether the type of doll provided moderates the efficacy of the intervention, and whether parent and child attachment to the doll and adherence to the intervention are associated with its outcomes.

Participants will be 160 children aged 3-8 from across Israel, whose parents perceive them to be distressed due to the war. Parents will undergo a brief phone interview to confirm the child's age and distress level. Subsequently, parents will be directed to complete a concise online survey, detailing their child's stress symptoms over the past week and exposure to traumatic war experiences. Demographic information, such as parent marital status, will also be collected.

The HuggyPuppy Intervention will then be delivered to all children via their parents. This brief psychosocial intervention was originally developed to reduce war-related stress in children (Sadeh et al., 2006). It involves a soft plush toy - originally a puppy - provided to the child along with a 'cover story', telling the child that 'Huggy' (the puppy) is far from home and looking for someone to look after it. The child is then asked to adopt Huggy, and take care of it when it is sad and lonely.

Children will be randomly assigned to receive one of five different types of dolls (dog with Velcro in palms, dog without Velcro in palms, monkey with Velcro in palms, bear, and rabbit). The doll will be delivered to their homes or places of shelter. During the course of 1 week of intervention, parents will receive three instructional videos (each lasting 1.5-5 minutes), guiding them on how to introduce the doll to their child. They will be encouraged to nurture a bond between the child and the doll, promoting activities like hugging and expressing emotions through it. Three weeks after the intervention, parents will be requested to complete a post-intervention questionnaire. This questionnaire will cover the child's symptoms, as well as the parent's anxiety, depression, and stress levels. Additionally, parents will provide feedback on their adherence to and experiences with the intervention.

The expected results of this study will provide empirical evidence on the effectiveness of the parent-delivered HuggyPuppy Intervention in ameliorating war-related stress in young children. Moreover, the study aims to enhance our understanding of potential moderating factors, such as the type of doll provided, and shed light on the crucial role of parent and child attachment to the intervention, offering valuable insights for the development of targeted interventions in the context of conflict-related stress.

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 (Participant)

盲法说明

Parents will not be masked to the purpose of the intervention, but will be unaware that there are different types of dolls that are being tested.

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 3-8 years old
  • Parents perceive child to be in distress due to the war (<1 on a scale from 1-5, 1=not at all distressed, and 5=very high distress).
  • Parent proficiency in Hebrew

排除标准

  • 未提供

结局指标

主要结局

Stress reactions

时间窗: This measure will be completed by parents at pre- and 3-weeks post-intervention.

A stress reaction checklist (SRCL) will be used to assess children's level of stress-related symptoms. These include 15 items, such as "excessive crying", "experiencing nighttime awakenings or nightmares", and "frequently speaks about death". A general item pertaining to the child's level of distress on a 5-point scale will also be administered.

次要结局

  • Intervention adherence and satisfaction(Post-treatment only)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Kahn

Senior lecturer

Tel Aviv University

研究点 (1)

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