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临床试验/NCT04851704
NCT04851704进行中(未招募)不适用

Child Self-regulation: Impact and Neurocognitive Underpinnings of a Psychosocial Intervention

University of Oslo1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
79
试验地点
1
主要终点
Emotional Go/Nogo task (EGNG)

研究概览

简要总结

The current pilot project will a) adapt an evidence-based psychosocial intervention program and conduct a randomized controlled trial with a group of Norwegian parents of preschool children, b) evaluate the intervention'simpact on child mental health and c) investigate the cognitive and physiological underpinnings of this effect.This pilot study will recruit 40 Norwegian parents of preschool children prior to the transition to starting school. Baseline measures will include parent emotion coaching and parent functioning, child emotion regulation, social and behavioral functioning, child behavioral and physiological indices of cognitive capacity and attention functioning, and school adjustment. Following completion of baseline assessment, parents will be randomized into Intervention or Wait-list conditions. Intervention parents will attend a 6-session group parenting program where they will learn to emotion coach their children and regulate their own emotions. Post-program, Intervention parents will complete program evaluation to determine program feasibility and acceptability. At 6-month follow-up baseline assessments will be repeated for Intervention and Wait-list participants with primary school teachers reporting on children's adjustment to school. Wait-list parents will then be offered the N-TIK program.

详细描述

Promoting the emotional functioning of preschool children prior to the transition to school has important implications for their adjustment and mental health. Parents can assist children to understand and regulate their emotions thereby better equipping the child as they face this often highly stressful and anxiety provoking period. In addition, we need more knowledge on how processes on both behavioral and physiological levels can contribute to explain the mechanisms underlying changes in child self-regulation influenced by parents and the home environment.

Thus, a 2 x 2 intervention design pilot study of the Norwegian version of Tuning in to Kids (N-TIK) comparing intervention and wait-list participants will examine:

i) Does N-TIK lead to better parent-reported parent emotion coaching? ii) Does N-TIK lead to better parent-reported child emotional competencies, mental health and adjustment? iii) Does N-TIK lead to improved child attentional and executive functions as measured by behavioral performance and changes in neural and pupillometric responses in experimental tasks? The intervention aims to improve the responsiveness of parents to emotions, both in themselves and their children. Theoretically, this is anticipated to lead to children developing greater awareness and knowledge of their own emotional experience, to reduced levels of emotionality, and to greater internal self-awareness of their emotions (cognitive awareness about emotional experience). These comprise some of the core emotional competencies relevant for enhancing the transition to school. In turn these competencies are anticipated to be related to greater emotional, cognitive and physiological regulation as assessed by experimental paradigms and physiological measures. For children at risk (due to limited emotional, cognitive, physiological and behavioural regulation), an intervention that assists their parents to learn specific skills that enhance their emotion-related parenting, these risks are likely to be mitigated.

This study will be highly innovative on several counts. It will: gather preliminary evidence using a 2 x 2 intervention design for the effectiveness of an emotion-focused parenting program using a Norwegian sample; use cutting-edge behavioral and physiological measures to see whether participation in N-TIK leads to improved child attentional and executive functions - critical skills that assist with learning and self-regulation; integrate important disciplines within psychology by combining an intervention including preventive actions with emotional, neurocognitive and physiological approaches within adevelopmental psychological framework.

Statistical Analyses Time 1 data will be examined to determine relationships between key constructs. ANCOVA will be used to examine changes over time and to compare Intervention and Wait-list participants on all outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •A preschool child aged 5-6 years old
  • •Parent of a preschool child aged 5-6 years old

排除标准

  • •Parents under the age of 18
  • •Parents not able to read and write in Norwegian

研究组 & 干预措施

Intervention: Tuning in to Kids parenting program

Experimental

Intervention groups receive the Tuning in to Kids parenting program

干预措施: Tuning in to Kids (Behavioral)

Control: Business as usual

No Intervention

Control groups have "business as usual", and then get offered the intervention program after 6 months follow-up assessment.

结局指标

主要结局

Emotional Go/Nogo task (EGNG)

时间窗: Six months: Change in EGNG from baseline to 6 months follow-up measured by lab assessment.

EGNG is a direct assessment of child behavior - an adaptation from the Go/NoGo task - a well-established cognitive paradigm. When modified with emotional stimuli in the form of faces with different positive and negative emotional expressions serving as either target or non-target, the task allows for behavioural assessment of emotion discrimination, emotion regulation and cognitive control, which are related, yet separable processes (Tottenham et al. 2011).

Test of Emotion Comprehension (TEC)

时间窗: Six months: Change in TEC from baseline to 6 months follow-up measured by lab assessment.

The TEC is a direct assessment measure used to capture child emotion understanding (Kårstad et al., 2015; Pons \& Harris, 2000). The TEC measures nine components of emotion understanding: 1) emotion recognition, 2) external cause, 3) desire, 4) belief, 5) reminder, 6) regulation, 7) hidden, 8) mixed, and 9) morally based emotions.

AX Continuous Performance Task (AX-CPT)

时间窗: Six months: Change in AX-CPT from baseline to 6 months follow-up measured by lab assessment.

AX-CPT is a direct assessment of child behavior - The AX-CPT task (a version of the classic Continuous Performance Test, Rosvold et al. (1956)) is among the tasks most frequently used to study adaptive cognitive control by cognitive and clinical neuroscientists (Cohen and Servan-Schreiber,1992; Servan-Schreiber et al.,1996). In particular, the task makes it possible to distinguish between proactive or reactive control modes (Braver (2012); Braver et al. 2007).

Parent Emotional Style Questionnaire (PESQ)

时间窗: Six months: Change in PESQ from baseline to follow up 6 months after baseline measured by questionnaire reports.

Parent Emotion Socialization Questionnaire (PESQ) is a scale with items that are scored from 1 to 5, where 5 indicates high levels of specific parenting beliefs (i.e. emotion coaching and emotion dismissive beliefs).

Coping with children negative emotions scale (CCNES)

时间窗: Six months: Change in CCNES from baseline to 6 months follow-up measured by questionnaire reports.

Coping with children negative emotions scale (CCNES) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of specific parenting behavior (i.e. supportive and nonsupportive parenting behavior).

Eysenck's child behavior questionnaire (ECBI)

时间窗: Six months: Change in ECBI from baseline to 6 months follow-up measured by questionnaire reports.

Eysenck's child behavior questionnaire (ECBI) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of behavior problems.

Preschool anxiety scale - revised (PAS-R)

时间窗: Six months: Change in PAS-R from baseline to 6 months follow-up measured by questionnaire reports.

Preschool anxiety scale - revised (PAS-R) is a scale with items that are scored from 1 to 5, where higher score indicates higher levels of anxiety.

次要结局

未报告次要终点

研究者

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

Evalill Bølstad, PhD

Associate Professor

University of Oslo

研究点 (1)

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