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临床试验/NCT01393691
NCT01393691已完成不适用

Interventions for Nighttime Fears in Preschool Children: Assessment of Predictors and Outcomes

alan apter2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Nighttime fears interview (child) and nighttime fears questionnaire (parents)

研究概览

简要总结

Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major problems in clinical services. The aim of this study is to test the efficacy of two interventions designed for preschool children suffering from NTF: (a) a CBT adaptation combining parent involved play, which will include multiple standard cognitive-behavioral techniques, namely psycho-education, problem solving via play, gradual exposure and reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia Axline's (1947) eight basic principles of play therapy. Parents will take an active part both in and in between treatment sessions in both intervention groups. In addition to the review of the outcomes of these interventions, the proposed study aims to identify variables that moderate and mediate treatment effects.

In an attempt to meet these aims, the investigators will recruit 90 children suffering severe NTF and their parents who seek treatment. At baseline the investigators will assess children's NTF and general fears, sleep patterns and disruptions, behavior problems and potential moderators (i.e. playfulness, oppositionality, desire for control and parental anxiety). Assessment will be based on both objective and subjective measures, including interviews with the child and parents, questionnaires and actigraphy. The investigators will then randomly assign these children to one of two conditions: CBT with parent involved play or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance, patient compliance, motivation etc.) will be evaluated after each of the active intervention sessions. The effects of the interventions will be assessed by comparing four time points: baseline, first week of intervention, 1 month and 6 months subsequent to administration.

The main hypotheses of the proposed study are: (a) A positive correlation will be found between the severity of NTF and the severity of sleep disruption at baseline, and a reduction in NTF will be associated with an improvement in sleep; (b) Both interventions will significantly reduce nighttime fears, but greater impact will be evident in the CBT group; (c) Higher levels of playfulness and lower levels of oppositionality and desire for control, as well as parental anxiety will predict desirable outcomes. (d) Stronger therapeutic alliances, in addition to higher levels of motivation and compliance will be associated with greater intervention effectiveness.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • NTF exist for a minimum of 2 months, with significant adverse impact on the child and the family, requiring parental involvement for at least two nights per week to comfort the child.

排除标准

  • major health or neurological-developmental problems
  • concurrent psychiatric treatment
  • concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears.

结局指标

主要结局

Nighttime fears interview (child) and nighttime fears questionnaire (parents)

时间窗: 1 week -6months

Children will be interviewed regarding the content, frequency and severity of their nighttime fears. Parents will complete a questionnaire regarding these issues.

nighttime fear and sleep logs

时间窗: 1 week- 6 months

Parents will be asked to report the level of their child's fear in the fear diary every night after bedtime, and every morning after the child has awoken from slumber. In addition, they will be asked to document the influence fears had on their child's sleep and bedtime routine, and the coping strategies that were implemented by themselves and by their child during the night.

次要结局

  • Activity-based sleep monitoring (Actigraphy)(1 week- 6 months)

研究者

发起方
alan apter
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

alan apter

Director of psychological medicine department at Schneider; Professor at Sackler School of medicine

Rabin Medical Center

研究点 (2)

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