跳至主要内容
临床试验/NCT07590778
NCT07590778已完成不适用

Preliminary Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) in Preterm-Born Infants Aged 0-2 Years With Post-Traumatic Stress Symptoms: A Multiple Baseline Experimental Design

Tanja Holtackers1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Child post-traumatic stress symptoms

研究概览

简要总结

This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care. Preterm infants often experience stressful events in the hospital, which can affect their emotional and behavioral development.

In this study, an adapted form (storytelling) of Eye Movement Desensitization and Reprocessing (EMDR) therapy was used with preterm born children aged 0 to 2 years. The treatment was delivered in a small group of participants, and changes in post- traumatic stress symptoms, sleep, emotional functioning, parental PTSD symptoms and perceived bonding and parent-infant interaction were monitored over time using parent reports.

The aim of the study is to evaluate whether this early intervention (EMDR, storytelling) is feasible, well accepted by families, and potentially effective in reducing post-traumatic stress related symptoms in this vulnerable population.

详细描述

Preterm birth exposes infants to repeated medical stressors during a critical period of development. These stressors may include invasive procedures, high levels of sensory stimulation, and separation from caregivers. Such early experiences can lead to post-traumatic stress symptoms, including excessive crying, sleep and feeding difficulties, heightened arousal, and problems with emotional regulation and parent-infant interaction and perceived bonding.

Evidence-based trauma-focused interventions for children under the age of two years are limited. Eye Movement Desensitization and Reprocessing (EMDR) is an established trauma-focused treatment in older children and adults, but its application in very young children is still emerging. The EMDR storytelling method is a developmentally adapted approach designed for use with infants and toddlers, involving active caregiver participation.

The aim of this study was to evaluate the feasibility, acceptability, and preliminary effectiveness of the EMDR storytelling method in preterm-born children aged 0 to 2 years with post-traumatic stress symptoms following medical experiences.

A non-concurrent multiple-baseline single-case experimental design was conducted, including 10 participants. Daily individualized trauma-related symptoms were monitored across baseline, intervention, post-intervention, and 3-month follow-up phases. In addition, standardized parent-reported questionnaires were used to assess child emotional and behavioral functioning, sleep problems, parent-child interaction, bonding difficulties, and parental post-traumatic stress symptoms at multiple time points.

Participants received up to six EMDR sessions of approximately one hour each.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm birth (<37 weeks gestational age)
  • Age between 0 and 24 months
  • Presence of frequent and severe post-traumatic stress symptoms (occurring daily to multiple times per week), considered related to medical trauma following premature birth
  • Not currently hospitalized
  • Availability of a parent or legal guardian able to provide informed consent

排除标准

  • Insufficient proficiency in Dutch to complete study procedures and questionnaires
  • Severe physical illness or medical condition that is considered to be the primary focus of clinical care and/or interferes with participation in the intervention
  • Current participation in other trauma-focused psychological treatment

研究组 & 干预措施

EMDR storytelling intervention

Experimental

Participants were preterm-born infants aged 0-2 years presenting with post-traumatic stress symptoms following medical experiences. All participants received the EMDR storytelling intervention, a developmentally adapted trauma-focused treatment involving caregiver participation. The intervention was delivered individually in up to six sessions of approximately one hour each. Outcomes were assessed across baseline, intervention, post-intervention, and 3-month follow-up phases.

干预措施: Eye Movement Desensitization and Reprocessing (EMDR) storytelling method (Behavioral)

结局指标

主要结局

Child post-traumatic stress symptoms

时间窗: Daily during baseline (minimum 14 days) through intervention (minimum 14 days up to 49 days) and post-intervention (minimum 14 days), and at 3-month post-intervention phase (14 days).

Daily idiosyncratic post-traumatic stress symptoms in preterm-born infants aged 0-2 years, assessed across baseline, intervention, post-intervention, and 3-month post-intervention phases. Symptoms were monitored using caregiver-reported daily ratings specific to each child's trauma-related stress responses (scale 0-100, higher scores indicate worse symptoms).

次要结局

  • Child emotional functioning(Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.)
  • Sleep disturbance in child(Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.)
  • Parental post-traumatic stress symptoms(Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.)
  • Parent-child bonding and interaction quality(Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.)
  • Child post-traumatic stress symptoms(Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.)

研究者

发起方
Tanja Holtackers
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tanja Holtackers

Clinical Psychologist in Training

St. Antonius Hospital

研究点 (1)

Loading locations...

相似试验

EMDR Therapy in Preterm-Born Infants With... | 临床试验