Measuring and Reducing Excessive Infant Crying (UTHealth THB)
Measuring and Reducing Excessive Infant Crying: A Randomized Trial
調査の概要
詳細な説明
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas Health Science Center at Houston
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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:
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Exclusion Criteria:
- cannot have a condition which would reasonably impact alertness or behavior
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：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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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アクティブコンパレータ：AAP Education
Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
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Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
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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 |
|---|---|---|
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Mean night-time crying
時間枠：2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Objectively recording night-time duration of excessive crying
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Mean sleep duration
時間枠：2 weeks after enrollment. Appproximately 6-8 weeks of life.
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objectively measuring infant sleep duration
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maternal Depression, Anxiety and Somatization
時間枠：At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Using the BSI-18 at study enrollment and conclusion.
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At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Salivary Biomarkers
時間枠：At Study Entry and at 2 weeks after enrollment
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We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
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At Study Entry and at 2 weeks after enrollment
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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