Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Intervention for Low-income Pregnant Women With Partner Abuse
調査の概要
状態
詳細な説明
Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA.
Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression.
All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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-
Rhode Island
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Providence、Rhode Island、アメリカ、02905
- Memorial Hospital
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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:
- Able to speak and read English sufficiently to complete the study procedures
- Willing and able to receive public assistance
- Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
- 35 weeks or less gestation
Exclusion Criteria:
- Meets current criteria for major depressive disorder or post-traumatic stress disorder
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1
Participants assigned to the ROSE program
|
Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help.
The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery.
Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
他の名前:
|
アクティブコンパレータ:2
Participants assigned to enhanced care as usual
|
Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic.
Participants will also receive educational material and a list of treatment resources for depression.
|
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 |
---|---|
Longitudinal Interval Follow-up Examination (LIFE)
時間枠:Measured at Year 1
|
Measured at Year 1
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Revised Conflict Tactic Scale (CTS2)
時間枠:Measured at Year 1
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Measured at Year 1
|
Edinburgh Postnatal Depression Scale
時間枠:Measured at Year 1
|
Measured at Year 1
|
The Davidson Trauma Scale
時間枠:Measured at Year 1
|
Measured at Year 1
|
The Arizona Social Support Interview Schedule
時間枠:Measured at Year 1
|
Measured at Year 1
|
Parenting Stress Index
時間枠:Measured at Year 1
|
Measured at Year 1
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Caron Zlotnick, PhD、Butler Hospital
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
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。