Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

EMDR Therapy in Preterm-Born Infants With Post-Traumatic Stress Symptoms (EMDR-INFANTS)

8 de maio de 2026 atualizado por: Tanja Holtackers

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

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.

Visão geral do estudo

Descrição detalhada

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.

The study was retrospectively registered.

The findings suggest that the intervention was feasible and acceptable in this sample, with no drop-out and no adverse events reported. Reductions in post-traumatic stress symptoms were observed in most participants following the intervention and were maintained at follow-up. Improvements were also observed in child emotional functioning, sleep, parent-child interaction, and parental stress symptoms.

These findings should be interpreted with caution given the small sample size and study design. Further research using controlled study designs is needed to confirm these results.

Tipo de estudo

Intervencional

Inscrição (Real)

10

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Utrecht
      • Utrecht, Utrecht, Holanda
        • St. Antonius Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: EMDR storytelling intervention
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.
The EMDR storytelling method is a developmentally adapted trauma-focused intervention based on Eye Movement Desensitization and Reprocessing (EMDR). The treatment is designed for infants and toddlers (in preverbal period) and involves caregiver participation. A structured storytelling approach is used to process traumatic medical experiences. Participants received up to six individual sessions of approximately one hour each.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Child post-traumatic stress symptoms
Prazo: 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).
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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Child emotional functioning
Prazo: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-reported measures of child emotional and behavioral functioning in preterm-born infants exposed to medical trauma. Assessed using standardized questionnaires: depressive symptoms (8 items; range 8-40), and anxiety (8 items; range 8-40) scales from the Dutch translation of the PROMIS Early Childhood Parent Report. Higher scores indicate worse symptoms.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Sleep disturbance in child
Prazo: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-reported sleep problems in preterm infants measured using standardized sleep-related questionnaire: The Dutch translation of the PROMIS Early Childhood Parent Report: sleep disturbances scale (4 items; range 4-20). Higher scores indicate worse symptoms.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parental post-traumatic stress symptoms
Prazo: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Self-reported parental symptoms of post-traumatic stress related to the child's medical history, assessed with a validated questionnaire: The Dutch translation of the PCL-5. Total scores (range 0-80) were used to examine changes in PTSD symptoms in parents. Higher scores indicate a higher degree of PTSD symptoms.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-child bonding and interaction quality
Prazo: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-reported bonding difficulties and quality of interaction between caregiver and child following medical trauma. Measured by using the standardized questionnaire: Dutch translation of the Post-partum Bonding Questionnaire (PBQ). The total score (range 0-125) is used , with higher scores indicating worse symptoms. And measured by the standardized questionnaire: The Dutch translation of the PROMIS Early Childhood Parent Report: Scale Child-caregiver interaction was assessed using a 5-item scale (range 5-25). Higher scores indicate improvement of symptoms.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Child post-traumatic stress symptoms
Prazo: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-reported measures of child post-traumatic stress symptoms in preterm-born infants exposed to medical trauma. Assessed using the standardized questionnaire: The Dutch translation of the Child and Adolescent Trauma Screener (CATS). Range 0-45, higher scores indicate worse symptoms.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Cadeira de estudo: Carlijn de Roos, PhD, Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de fevereiro de 2025

Conclusão Primária (Real)

31 de janeiro de 2026

Conclusão do estudo (Real)

1 de fevereiro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2026

Primeira postagem (Real)

15 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Due to the General Data Protection Regulation (GDPR), the European privacy legislation applicable in this study, raw data may not be shared with other parties.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever