Testing and Development of a Sleep Training Mobile Health Application
Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life
調査の概要
詳細な説明
Problems with bedtime and night-wakings are common in early childhood. Behavioral interventions to address these sleep problems are commonly referred to as "sleep training" and are effective but difficult for some parents to perform. The investigators have developed a prototype of a novel smartphone application designed to assist parents throughout this process.
The smartphone application first collects basic information from the parents, including: first name of child, number of caregivers participating in bedtime, tolerance of caregivers for crying, and basic information about timing of sleep and wake, as well as information about the usual order of events at bedtime. At each step, a brief (2-3 paragraph) is provided to explain the rationale for the next step, as well as concrete advice on how to succeed. It then walks parents through proven techniques to improve sleep in children in a stepwise fashion.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- english speaking
- parent of child age 6-24 months
- target child sleeping in crib in his or her own room (not the same room as the parents or a sibling)
- actively looking to sleep train their child
- own an iOS or Android smartphone
Exclusion Criteria:
- bedsharing/cosleeping with child
- target child has a known developmental delay
- target child has a significant health issue affecting his/her sleep (failure to thrive, congenital heart disease, etc).
研究計画
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：支持療法
- 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：Application Users
English-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.
|
Every evening the application provides a list of the planned bedtime activities as well as the recommended bedtime.
The steps are 1) positive bedtime routine 2) bedtime fading 3)addressing nocturnal feeding 4) extinction protocol
|
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 |
|---|---|---|
|
Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)
時間枠：study entry and 1 month
|
The question is: Average number of night wakings per night: ____________ Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. |
study entry and 1 month
|
|
Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)
時間枠：study entry and 3 months
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.
The question is: Average number of night wakings per night: ____________
|
study entry and 3 months
|
|
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)
時間枠：study entry
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep as a problem? □ A very serious problem □ A small problem □ Not a problem at all |
study entry
|
|
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)
時間枠：3 months
|
Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.
The question is: Do you consider your child's sleep as a problem?
|
3 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1603017350
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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