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パワーダウンのパイロット研究: 就寝時の新しい操作プロトコル

2026年11月2日 更新者:Amy Hartman, PhD, OTR/L、University of Pittsburgh

電源を切る: 自閉症児の睡眠をサポートする就寝時間の操作に関するパイロット研究

The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:

  1. Is the Power Down feasible for caregivers to do each night?
  2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?

調査の概要

状態

積極的、募集していない

詳細な説明

Interested participants will contact the research team and complete screening to determine eligibility (see Screener document). For eligible participants, the informed consent form will be sent and a consent call or video call will be scheduled. The study team will complete the consent process with eligible caregivers (on phone or via video call) and a consent form will be sent via DocuSign for the caregiver to sign.

Following the consent process, questionnaires (below) will be sent via REDCap to complete and a in-lab training meeting will be scheduled. During the in-lab training meeting, the PI (Hartman) will complete the bedtime manipulation training (details found in the Power Down Protocol document found in the Basic Study Information section of this IRB). After the education training, the caregiver(s) will be instructed in the "Power Down massage" and they will practice with their child in the lab and receive feedback on their delivery of the massage. The caregiver(s) and their child will also be given an activity monitor and instructed on the use and care of the device. The caregiver(s) will also review the morning and evening diaries to be completed throughout the study with a study team member.

Following the training session, the caregiver(s) and their child will complete the power down massage nightly, just prior to the time the child would start to try to fall asleep (e.g., after caregiver says "good night", when caregiver leaves the room), for two weeks. They will also complete a morning and evening diary entry, which will be sent virtually. At the end of the two weeks, the activity monitor will be returned to the study team. The participants will connect with the study team to complete an exit interview about their participation in the study and questionnaires about the treatment acceptability.

研究の種類

介入

入学 (推定)

10

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • University of Pittsburgh

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

6年~10年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)
  2. Parent-reported autism diagnosis for child
  3. Parent-reported extended and problematic settling down delay
  4. Parent-reported sensory over-responsivity (a "yes" to at least 8 items in the sensory screening section of the checklist)
  5. Parent willing to participate in nightly routine during the 2 week study
  6. Located within the Pittsburgh area

Exclusion Criteria:

  1. Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.
  2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
  3. If a child spends bedtime at a different caregiver's home for >50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.

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:なし
  • 介入モデル:単一グループの割り当て
  • 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:Power Down pilot arm

All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.

The Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for autistic children). The Power Down incorporates sensory-based tools (gentle tactile pressure and auditory cues) to support nervous system regulation prior to attempting sleep onset. Participants (caregivers and their child) will be educated in the Power Down protocol and data collection methods for the 2 week intervention trial. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep. The child will also wear a watch-like activity monitor (ActiGraph GT9x) for the 2 week period throughout the day and night to measure changes in sleep and activity patterns. Caregivers will complete daily diary questions in the morning and evening reporting their child's emotions and sleep timing.

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
Recruitment rates of participants through the trial
時間枠:1 year

We will use recruitment rates as one of our primary measure of feasibility of this protocol. Benchmark include: Recruitment rates: >2 caregiver-child dyads enrolled per month

1 year
Retention rates of participants through the trial
時間枠:2 weeks

We will use retention rates as one of our primary measure of feasibility of this protocol. Benchmarks include: Retention rates: >80% of consented dyads will complete at least 10 nights of the Power Down during the 2 week intervention trial.

2 weeks
Caregiver reported acceptability
時間枠:Taken at end of 2-week intervention trial

During the exit interview, caregivers will be asked "Is this intervention an acceptable option for families who are experiencing bedtime difficulties" as a primary measure of acceptability. >80% of enrolled participants who completed at least 4 days of the Power Down manipulation will report that the intervention is an acceptable option for families like theirs who are experiencing bedtime difficulties (question on post-intervention questions).

Taken at end of 2-week intervention trial

二次結果の測定

結果測定
メジャーの説明
時間枠
Treatment adherence
時間枠:During 2 week trial

As a secondary measure of feasibility, caregiver reported rates of treatment adherence will be measured. Caregivers will report completing the Power Down massage at least 10/14 nights during the 2 week intervention.

During 2 week trial
Data collection rates- Questionnaires
時間枠:At baseline

We will measure completion rates of questionnaires as a secondary measure of feasibility.

Benchmark:

>75% of questionnaires will be completed

At baseline
Data collection rates- Daily diaries
時間枠:2 weeks

We will measure completion rates of the number of daily diaries completed as a secondary measure of feasibility.

Benchmark: >75% of daily diaries will be completed

2 weeks
Data collection rates- Wearing the actigraphy watch
時間枠:2 weeks

We will measure the amount of days/nights children wore the actigraphy watch as a secondary measure of feasibility.

Benchmarks: Children will tolerate wearing watch for at least 10/14 nights (6+ hours during their reported sleeping times)

2 weeks
Credibility/Expectancy Questionnaire
時間枠:2 weeks

We will gather information about the caregiver's perceived credibility (questions 1-3, Set 1) and expectations (question 4 Set 1, questions 1-2 Set 2) related to the intervention at baseline and at the end of the intervention. Each question is rated on a 9-point scale, with 1 being "do not agree at all" and 9 being "strongly agree).

Benchmark:

At both baseline and post-intervention, caregivers will rate the intervention an average of 6 (on a 9 point scale) for both credibility and expectations, indicating more than somewhat confident.

2 weeks

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:Amy G Hartman, PhD、University of Pittsburgh

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)

2025年7月5日

一次修了 (実際)

2026年11月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2024年4月12日

QC基準を満たした最初の提出物

2024年4月22日

最初の投稿 (実際)

2024年4月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年11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11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.

IPD 共有時間枠

Data will be available to share after publication of findings or 2 years after the end of the study, whichever comes first.

IPD 共有アクセス基準

Data will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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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