Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers (Project Solve)
Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial
Premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance. Premature infants of low-income families face additional social risks known to worsen these outcomes. The Institute of Medicine recognized this important public health problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality of follow-up care for preterm infants discharged from the neonatal intensive care unit (NICU). The underpinning of this proposal is that maternal depression - common among families of premature infants - interferes with adherence to follow-up services, and (both through this mechanism and directly) adversely impacts child health and development. Conversely, alleviating depressive symptoms among these women represents a promising strategy to improve adherence to NICU follow-up services and to improve the outcomes of this vulnerable population.
This project aims to mitigate the adverse effects of maternal depression in this specific high-risk population by testing a theory-based, parent-directed empowerment strategy, called Problem Solving Education (PSE). In the past, similar strategies have been proven effective for improving the mood and functioning of depressed adults, and for improving adherence to medical treatment. However, they have never been tested in the setting of a parent-child relationship or among families of premature infants.
This project involves a clinical trial of PSE among 50 low-income mothers at risk for depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts Medical Center. The investigators aim to determine the impact of PSE on maternal depressive symptoms and functioning, and adherence to child health supervision and immunization schedules, vision screening, and early intervention evaluation for babies with suspected developmental delays.
Approximately 100,000 children are born prematurely to low-income families each year. Parent-directed PSE aims to improve outcomes for these children through the prevention and/or attenuation of maternal depressive symptoms, as well as through family activation and promotion of adherence to follow-up care. If successful, PSE could also provide the cornerstone of a more generalizable empowerment strategy for families of children with chronic medical conditions.
調査の概要
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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-
Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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Boston、Massachusetts、アメリカ、02118
- Tufts Medical Center
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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:
- Baby is ≤ 33 weeks gestational age and is expected to survive.
- Baby qualifies to receive WIC
- Mother is comfortable in English or Spanish.
Exclusion Criteria:
- Mother has psychosis
- Mother endorses suicidal ideation
- Custody of baby is uncertain
- Mother is cognitively limited, per judgment of NICU attending physician
- Baby is critically ill, per judgment of NICU attending physician
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:2
普段のお手入れ
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実験的:1
Problem Solving Education, a psycho-educational intervention
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psycho-educational intervention
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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 |
時間枠 |
---|---|
Maternal Depressive Symptoms
時間枠:6 months
|
6 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Health Care Supervision Schedule for Children
時間枠:6 months
|
6 months
|
Immunization Schedule for Children
時間枠:6 months
|
6 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
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
本研究に関する用語
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。
Problem Solving Educationの臨床試験
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない
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George Washington UniversityTranscultural Psychosocial Organization Nepal完了
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Fundación San Carlos de MaipoUniversidad de los Andes, Chileわからない
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Fundación San Carlos de MaipoUniversidad de los Andes, Chileわからない