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子供の悪夢に対するイメージリハーサル療法と組み合わせたドリームチェンジャー介入

2026年9月30日 更新者:Michal Kahn、Tel Aviv University

子供の悪夢を軽減するためのイメージリハーサル療法と組み合わせたドリームチェンジャー介入の有効性

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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

介入

入学 (実際)

126

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Israel
      • Tel Aviv、Israel、イスラエル
        • Tel Aviv University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

3年~10年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

介入なし:Waitlist control

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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Nightmare frequency and severity
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Child sleep problems
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Parent compliance and satisfaction with the intervention
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Michal Kahn, PhD、Tel Aviv University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年5月7日

一次修了 (実際)

2026年3月30日

研究の完了 (実際)

2026年6月30日

試験登録日

最初に提出

2024年5月5日

QC基準を満たした最初の提出物

2024年5月8日

最初の投稿 (実際)

2024年5月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5日

QC基準を満たした最後の更新が送信されました

2026年9月30日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 0008185-1

個々の参加者データ (IPD) の計画

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いいえ

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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