跳至主要内容
临床试验/NCT04108949
NCT04108949终止不适用

Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children

University Hospital, Akershus3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
3
主要终点
Coping with Toddlers' Negative Emotion Scale

研究概览

简要总结

The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.

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)

盲法说明

Outcome assessors are blinded to treatment condition and receive no information about which treatment the participant will receive or have received.

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

  • Referred children aged 2-5 years
  • The child is enrolled in daycare
  • The child is displaying problems with emotional dysregulation

排除标准

  • Parent not sufficiently proficient in Norwegian Language to Complete assessment
  • Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver
  • The child has already been diagnosed with an autism spectrum disorder

结局指标

主要结局

Coping with Toddlers' Negative Emotion Scale

时间窗: CTNES will be completed at baseline, post treatment (week 12) and follow-up month 9 after inclusion) to evaluate change from baseline to post-treatment and follow-up.

A measure of parental behaviors in respond to toddlers' emotions. CTNES consists of 12 hypothetical situation where parents rate their likelihood of responding in six different ways on a scale from 1 (very unlikely) to 7 (very likely).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Aalberg

Researcher

University Hospital, Akershus

研究点 (3)

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