SUDの産後の母親のための夜の休息
住宅治療プログラムにおける物質使用障害のある産後の母親のための夜間レスパイトケアのパイロットの実現可能性
調査の概要
詳細な説明
この単一アームのパイロット実現可能性調査では、自宅で物質を使用している産後早期に物質使用障害を持つ 20 ～ 25 人の母親のそれぞれに、週に約 3 泊、6 週間 (合計 18 泊) 提供される、一晩の乳児レスパイト ケアの実施を評価します。障害治療プログラム。 一晩のレスパイトケアは8時間続き、毎朝1時間は乳児特有の気質と手がかりについての教育を提供するために予約されています. このプログラムは、マサチューセッツ州児童家庭局 (DCF)、ボストン ベビー ナース アンド ナニー (BBNN)、2 つの居住型治療プログラム、およびマサチューセッツ総合病院とのユニークな公的/私的/学術的パートナーシップです。
BBNNと提携して、SUDの影響を受けた家族にレスパイトケアを提供することに関心のある新生児ケアの専門家は、ボストン地域の2つの居住治療プログラムに住む産後の家族とペアになります. マサチューセッツ州サマービルのニューデイとマタパンのエントレファミリアは、MGHと提携して、スクリーニングとベースライン摂取を完了し、夜間のレスパイトケアを受け、介入の完了時と3か月でフォローアップ研究訪問を完了するために個人を募集します介入後。
この研究では、さまざまな方法を使用して、プログラム参加者、レスパイト介護者、在宅治療の夜間スタッフ、および研究スタッフの視点を通じて、このパイロット プログラムの経験を含むパイロット介入の実現可能性と受容性を理解します。 レスパイト ケア提供者と居住治療プログラムのスタッフは、各ペアが割り当てられた時間のレスパイト ケアを受けた後、このプログラム参加者の具体的な経験を振り返るためにインタビューに参加するよう招待されます。
BBNN、DCF、および在宅治療プログラムの指導スタッフは、研究の完了時にフォーカス グループに参加するよう招待され、組織のレンズを通してこのプログラムの実現可能性、受容性、および実装を理解します。 また、介入の適切性と実現可能性についての認識を評価することを目的とした簡単な調査に参加するよう招待されます。
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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Mattapan、Massachusetts、アメリカ、02126
- Entre Familia Residential Treatment Program
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Somerville、Massachusetts、アメリカ、02143
- New Day Residential Treatment Program
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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
説明
包含基準:
- 生後12ヶ月未満の乳児の世話。
- 乳児の主な世話人であること。
- 物質使用障害の DSM-5 診断を受けている。
- 現在、参加している居住治療プログラムに居住している
- 英語力が限られている英語またはスペイン語話者
除外基準:
- 未治療の深刻な精神疾患を患っている。
- 未治療の物質使用障害があるか、この人が積極的に物質を使用しているという既存の懸念がある。
- 家庭内での以前の暴力または親密なパートナーによる暴力の履歴がある。
- 家庭の安全性に関する情報が不安定または不足しているというプロバイダの懸念。
- 生後12か月未満の乳児を積極的に育てていない
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 |
|---|---|
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実験的：ナイトレスパイトケア
レスパイトケアサポートの前後に教えられる瞬間を通じて提供される親のスキルを含む、6週間にわたる18泊の夜間レスパイトケアセッション
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(上記の説明を参照)
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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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Recruitment
時間枠：Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
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Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention
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Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
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Participation in Intervention
時間枠：Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
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Reciept of any nights of respite care during the intervention period
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Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
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Study Feasibility
時間枠：At completion of the intervention, up to six weeks following the completion
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Count of total number individuals completing intervention and retained through study follow up
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At completion of the intervention, up to six weeks following the completion
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Study Acceptability
時間枠：At completion of the intervention, up to six weeks after last night of respite.
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Feedback in semi-structured interviews with participants
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At completion of the intervention, up to six weeks after last night of respite.
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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 Sleep Quantity
時間枠：Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
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Measurement of total sleep using actigraphy device in a 24hr period
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Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
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Ability to Fall Asleep
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Insomnia Sleep Index (Measured on a scale of 0-28).
Insomnia symptoms were assessed using a brief insomnia symptom score capturing difficulty initiating sleep, maintaining sleep, and sleep satisfaction.
Higher scores indicate greater insomnia severity.
This measure was analyzed as a single continuous outcome reflecting insomnia symptom burden.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Sleep Quality
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Single Item Sleep Quality Scale; Overall perceived sleep quality was assessed using a single-item self-report measure asking participants to rate their global sleep quality over a recent time period. Higher scores reflect better perceived sleep quality. Single-item sleep quality measures have demonstrated sensitivity to change and strong correlations with multi-item sleep scales in postpartum populations. Participants rate their overall sleep quality using a single-item self-report measure. Scores range from 0 to 10, where 0 = terrible sleep quality and 10 = excellent sleep quality. Higher scores indicate better perceived sleep quality. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum Sleep Quality
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum-specific sleep quality was measured using the Postpartum Sleep Quality Scale is a caregiver-reported measure of postpartum sleep quality. The PSQS includes the following subscales: Infant-Related Sleep Disruption subscale: range 0-42 Physical Symptoms subscale: range 0-42 Total PSQS score: range 0-84, calculated by summing item responses across subscales. For all PSQS scores, higher values indicate worse postpartum sleep quality and greater sleep burden. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Maternal Mental Health - Depression
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Patient Health Questionnaire-8: Depressive symptoms were measured using the PHQ-8, an 8-item self-report scale assessing core symptoms of depression over the past two weeks.
Items are scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 24.
The PHQ-8 is a unidimensional measure and is widely used in postpartum and population-based studies.
A higher score indicates greater degree of depressive symptoms
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Maternal Mental Health - Anxiety
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Anxiety symptoms were assessed using the GAD-7, a validated 7-item self-report measure of generalized anxiety symptoms over the past two weeks.
Items are scored on a 0-3 Likert scale, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
The GAD-7 is unidimensional and has demonstrated strong reliability and validity in perinatal populations.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Recovery Capitol
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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The BARC-10 is a 10-item self-report measure assessing personal, social, and community resources that support recovery from substance use disorder. Each item is scored from 1 to 6 and summed to create a total score. Total score range: 10-60 Higher scores indicate greater recovery capital and a better recovery-related outcome. The scale is analyzed as a single total score. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Stress
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a 36-item caregiver-reported measure that yields three subscale scores and a Total Stress Score: Parental Distress (PD): range 12-60 Parent-Child Dysfunctional Interaction (P-CDI): range 12-60 Difficult Child (DC): range 12-60 Total Stress Score: range 36-180, calculated as the sum of the three subscales Higher scores indicate greater parenting stress and a worse outcome. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Bonding
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum Bonding Questionnaire (PBQ); The PBQ is a 25-item caregiver-reported measure assessing disturbances in the parent-infant relationship. It includes the following subscales: Impaired Bonding: range 0-60 Rejection and Anger: range 0-36 Infant-Focused Anxiety: range 0-20 Risk of Abuse: range 0-12 Total PBQ score: range 0-100, calculated by summing all items Higher scores indicate greater bonding difficulties and a worse outcome. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Self-efficacy
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parenting self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Scale, a multi-item self-report instrument assessing caregivers' confidence in their parenting skills and ability to manage parenting tasks. The Perceived Maternal Parenting Self-Efficacy Scale is a 20-item self-report measure assessing caregivers' confidence in their parenting abilities and performance of parenting tasks. Total score range: 20-80 (20 items scored 1-4 and summed) Higher scores indicate greater parenting self-efficacy and a better outcome. The scale is analyzed as a total score. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Social Support
時間枠：Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Perceived social support in the postpartum period was assessed using the Postpartum Social Support Screening tool, a caregiver-reported measure evaluating emotional, instrumental, and informational support.
The scale includes multiple items and is commonly analyzed as a total score reflecting overall perceived support.
There are 9 total questions that range from 1 (none of the time) to 5 (all of the time) and the total score is summed.
The scores can range from 9-45 and and high score indicate higher postpartum social support.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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協力者と研究者
捜査官
- 主任研究者：Davida M Schiff, MD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。