Improving Preterm Outcomes by Safeguarding Maternal Mental Health
調査の概要
詳細な説明
Preterm infants are born at biological risk for poor health and developmental outcomes; and those born to low-income families face additional social risks known to further interfere with healthy child development. In its 2006 report, Preterm Birth, the Institute of Medicine (IOM) stated the public health importance of optimizing the developmental outcomes of preterm infants, and specifically called for novel postnatal intervention strategies to accomplish this goal. Our proposed strategy is based on the premise that preventing maternal depression - and optimizing maternal functioning in specific domains that mediate the relationship between maternal depression and adverse child effects - will ultimately improve the developmental outcomes of this vulnerable child population.
Problem Solving Education (PSE) is a cognitive behavioral strategy that aims to impart recipients with skills to reduce the impact of stress on personal functioning, and thereby prevent depression. The present project is a randomized trial of a 6-session intervention based on PSE. the investigators aim to enroll 325 mother-infant dyads in four NICUs - Boston Medical Center, Tufts Medical Center, Beth Israel Deaconess Medical Center, and Brigham and Womens Hospital. Over 12-months of follow-up, the investigators will assess the effects of PSE on a series of outcome measures for mothers, a series of measures that represent risk mechanisms by which maternal depression is theorized to impact young children, and a series of child functioning measures.
Primary aims. Regarding outcomes for mothers, the investigators aim to:
- Decrease the incidence of major depressive episode (MDE) and improve depressive symptom trajectories during the first postpartum year; and
- Improve general and parental functioning, as measured by valid and reliable scales.
Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:
- Improve mothers' sense of mastery, and decrease their caregiver burden and social isolation;
- Improve adherence to evidence-based quality indicators for NICU follow-up care;
- Improve maternal sensitivity and mother-child interaction patterns; and
- Improve infant social engagement, emotionality, and cognitive functioning.
Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:
- On the infant level: severity of infant illness.
- On the maternal and family level: maternal trauma history, extended family functioning, and intervention adherence.
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、02215
- Beth Israel Deaconess Medical Center
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、アメリカ、02111
- Tufts Medical Center
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Boston、Massachusetts、アメリカ、02118
- Boston 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 26-34 weeks gestational age
- Baby qualifies to receive Medicaid
- Mother comfortable in English or Spanish
- Singleton or twin gestation
- Baby is expected to survive
Exclusion Criteria:
- Mother in major depressive episode or endorses suicidality
- Mother with psychosis or otherwise cognitively limited
- Mother with known active substance use; custody of infant uncertain
- Infant is critically ill
- Triplets or higher number gestation
- Mother who is enrolled in another study receiving the same intervention that we are testing
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：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：トリプル
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：Problem Solving Education tailored to NICU
NICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time.
The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization.
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介入なし：Control
Both study groups receive standard NICU medical, social work, and nursing services.
At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker.
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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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Incidence of major depressive episode and depressive symptom trajectories
時間枠：one year
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To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID).
Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment.
Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
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one year
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General Functioning
時間枠：one year
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General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales.
The SAS will be administered at 6 and 12 months of follow-up.
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one year
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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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Caregiver burden, mastery and social support
時間枠：one year
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The Coping Health Inventory for Parents is a valid and reliable instrument designed to measure parents' response to managing family life when they have an ill child.
It will be administered together with the Pearlin Mastery Scale and the Medical Outcomes Survey Social Support Scale.
Administration of these scales will occur at 6 and 12 months of follow-up.
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one year
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Adherence to recommended NICU follow-up care
時間枠：one year
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We assess the following measures of adherence to NICU follow-up care:
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one year
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Parent-child interaction
時間枠：one year
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We will videotape and microcode a 10-minute mother-infant free play session according to the parent, infant, and dyadic scales of the Coding Interactive Behavior Manual (CIB).
We will assess the following composites: maternal sensitivity; intrusive and withdrawn maternal interactions; and depressed mood and positive affect.
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one year
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Socio-emotional functioning
時間枠：one year
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We will assess the CIB infant social engagement composite.
We will assess negative infant emotionality using the 4-minute 'Mask Task' of the Laboratory Temperamental Assessment Battery (Lab-TAB).
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one year
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Cognitive functioning
時間枠：one year
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We will use the MacArthur-Bates Communicative Development Inventory.
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one year
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協力者と研究者
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 (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
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。