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A intervenção DreamChanger em combinação com terapia de ensaio de imagens para pesadelos infantis

30 de setembro de 2026 atualizado por: Michal Kahn, Tel Aviv University

Eficácia da intervenção DreamChanger em combinação com terapia de ensaio de imagens para reduzir pesadelos em crianças

This clinical trial will test the efficacy of parent-delivered DreamChanger Intervention in combination with Imagery Rehearsal Therapy (IRT) for reducing the frequency and severity of nightmares in children aged 3-10. Children will be randoimized to either the combined intervention or to a waitlist control group.The intervention will include providing children with the DreamChanger remote, and providing parents with instructional videos, explaining how to use the device along with the IRT strategy to address nightmares.

At baseline, mid-treatment, and post-treatment, parents in both groups will complete questionnaires asking about the child's nightmares, sleep, externalizing and internalizing symptoms, PTSD symptoms, demographic characteristics, and parent sleep and distress. Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention, as well as a 3-month follow-up assessment.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Nightmares, characterized as distressing dreams often leading to awakening, are relatively common in young children. However, approximately 3-6% of children endure recurrent nightmares, occurring at least once per week, causing significant distress and impairment. These persistent nightmares can be idiopathic or post-traumatic, and may be linked to conditions such as nightmare disorder or post-traumatic stress disorder (PTSD). Children experiencing recurrent nightmares face an elevated risk for various maladaptive consequences, including reduced sleep quality and quantity, heightened nocturnal anxiety, and challenges in emotional, social, and academic functioning. Moreover, parents often experience disruptions in their own sleep, which may lead to adverse health outcomes. Hence, the demand for effective interventions to mitigate the multifaceted burdens associated with recurrent nightmares is pronounced.

The most established intervention for children struggling with recurrent nightmares is Imagery Rehearsal Therapy (IRT). This approach aims to diminish the frequency and intensity of nightmares by encouraging children to engage with and modify the content of their nightmares through visualization and rehearsal techniques. Studies assessing the efficacy of IRT in children have demonstrated significant reductions in nightmare frequency and associated distress following treatment. However, the evidence base for this intervention remains limited, with only one small-scale (N=20) randomized controlled trial (RCT) conducted in children to date. Correspondingly, there is a critical need for further research to evaluate treatment effectiveness in children.

Furthermore, despite the promise of IRT in reducing nightmare frequency and intensity, approximately 30% of children do not sufficiently benefit from treatment. This underscores the necessity to refine and tailor this intervention to better address the characteristics of children. To date, research has yet to explore the potential advantages of augmenting IRT with additional components. The DreamChanger intervention offers a novel approach specifically designed for young children experiencing recurrent nightmares. Utilizing a remote-control-like device emitting a soft light, this cognitive intervention empowers children to "change the channel of their dreams", fostering a sense of mastery and control. A recent RCT demonstrated the efficacy of the DreamChanger in reducing nightmares and anxiety in young children. Building upon these findings, we posit that combining IRT with the DreamChanger may enhance treatment outcomes. Encouraging children to utilize the DreamChanger remote during the rehearsal of alternative dream scenarios may establish associations between the remote and alternative dream imagery, potentially improving the mental accessibility of imagery when using the remote at night. Thus, the DreamChanger has the potential to augment IRT by further stimulating the child's imagination and sense of mastery, while also facilitating the rehearsal and accessibility of alternative dream imagery.

This study seeks to advance scientific knowledge regarding interventions for pediatric nightmares by examining the efficacy of a novel treatment approach - a combination of IRT with the DreamChanger intervention - to alleviate recurrent nightmares and improve sleep quality in young children. This augmented intervention will be compared to a waitlist control group in an RCT. The research plan is based on an RCT design, with 2 arms (intervention vs waitlist control) and assessment points at baseline, mid-treatment, post-treatment, and for the intervention group - an additional 3-month follow-up.

Tipo de estudo

Intervencional

Inscrição (Real)

126

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

    • Israel
      • Tel Aviv, Israel, Israel
        • Tel Aviv University

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

3 anos a 10 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • child aged 3-10 years
  • parents aged over 18 years
  • child experiencing distressing nightmares at least once per week on average, for at least 1 month.

Exclusion Criteria:

  • Child receiving concurrent treatment for nightmares, sleep, or anxiety
  • Child diagnosed with a medical sleep problem (e.g., OSA, RLS)

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: DreamChanger combined with Imagery Rehearsal Therapy

Families will receive the DreamChanger remote along with 3 instructional videos for parents, explaining how to present the remote to children, and how to rehearse alternative dream imagery using the DreamChanger remote.

Families will receive the DreamChanger remote along with 3 instructional videos for parents, explaining how to present the remote to children, and how to rehearse alternative dream imagery using the DreamChanger remote.

Sem intervenção: Waitlist control

Families will be placed on a waitlist, and receive the intervention 6 weeks after baseline

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Nightmare frequency and severity
Prazo: Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up

Nightmare severity, frequency and related distress, as assessed using a modified version of the Nightmare Disorder Index

Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Child sleep problems
Prazo: Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up

Sleep difficulties such as frequent awakenings, prolonged nighttime wakefulness, and short sleep duration, as assessed uding the Child Sleep Habits Questionnaire.

Baseline, mid-treatment (2 weeks following baseline), post-treatment (4 weeks following baseline), and at a 3-month follow up
Child externalizing and internalizing problems
Prazo: Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up

Child behavioral problems, as assessed using the Strengths and Difficulties Questionnaire

Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up
Parent distress
Prazo: Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up

Parent depression, anxiety, and stress symptoms, as assessed using the DASS-21.

Baseline, post-treatment (4 weeks following baseline), and at a 3-month follow up

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Parent compliance and satisfaction with the intervention
Prazo: Mid-treatment and post-treatment (4 weeks following baseline)

Parent adherence to the intervention (e.g., watching the instructional videos, rehearsing the alternative dream scenarios, etc.) will be assessed, along with items regarding parents' satisfaction with the intervention.

Mid-treatment and post-treatment (4 weeks following baseline)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Michal Kahn, PhD, Tel Aviv University

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)

7 de maio de 2024

Conclusão Primária (Real)

30 de março de 2026

Conclusão do estudo (Real)

30 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

5 de maio de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2024

Primeira postagem (Real)

10 de maio de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 0008185-1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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