Social Circumstances, Parenting Techniques, and Infant Development
2020年1月27日 更新者：Catherine Monk、New York State Psychiatric Institute
Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:
- The feasibility of applying this protocol with a low SES population
- The effectiveness of the intervention compared to usual care
- If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
- Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.
調査の概要
詳細な説明
Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).
The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.
By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.
研究の種類
介入
入学 (予想される)
60
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
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New York
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New York、New York、アメリカ、10032
- Columbia University Medical Center
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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
18年～45年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- Healthy pregnant women between 24 and 38 weeks gestation (based on self-report)
- Ages 18-45 (based on self-report) 3. English speaking (based on self-report)
- Salary indicated to be at New York City standardized "Struggling level" or lower - $47,700 annual for a family of 4 (based on self-report)
- Experiencing one or more of nine social adversity hardships (based on self report)
- Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
- Receiving standard prenatal care (based on self-report)
Exclusion Criteria:
- Multi-fetal pregnancy (based on self-report)
- Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
- Acute medical illness or significant pregnancy complication (based on self-report)
- Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
- Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Resources for Postpartum Parenting
Behavioral intervention will include techniques to help mothers get their infants to cry/fuss less and sleep more to determine if this has an effect on prevalence of postpartum depression in low SES women and if it improves the quality of mother-infant interaction and subsequent child development.
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The intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad - the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment.
Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship.
他の名前：
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介入なし：Control Group
This group will not receive the coaching tips to help babies cry less and sleep more.
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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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Change in maternal mood and prevalence/severity of postpartum depression.
時間枠：6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
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Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.
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6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
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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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The effect of behavioral intervention for infants on infant development
時間枠：4 months (infant age)
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Investigators will use neurodevelopmental assessments (Bayley Scale of Infant Development, Still Face Protocol, Free Play Observation, and Conjugate Kicking Task) and cortisol reactivity to assess infant development at 4 months of age.
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4 months (infant age)
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The effect of behavioral intervention on infant sleep and fuss behavior
時間枠：6 weeks, 4 months (infant age)
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The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
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6 weeks, 4 months (infant age)
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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。
捜査官
- 主任研究者：Catherine Monk, Ph.D.、NYPI, CUMC
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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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)
2014年3月1日
一次修了 (実際)
2019年12月1日
研究の完了 (実際)
2019年12月1日
試験登録日
最初に提出
2014年3月28日
QC基準を満たした最初の提出物
2014年4月21日
最初の投稿 (見積もり)
2014年4月23日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月28日
QC基準を満たした最後の更新が送信されました
2020年1月27日
最終確認日
2020年1月1日
詳しくは
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。