- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00602732
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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02905
- Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
Participants assigned to the ROSE program
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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.
Altri nomi:
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Comparatore attivo: 2
Participants assigned to enhanced care as usual
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Longitudinal Interval Follow-up Examination (LIFE)
Lasso di tempo: Measured at Year 1
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Measured at Year 1
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Revised Conflict Tactic Scale (CTS2)
Lasso di tempo: Measured at Year 1
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Measured at Year 1
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Edinburgh Postnatal Depression Scale
Lasso di tempo: Measured at Year 1
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Measured at Year 1
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The Davidson Trauma Scale
Lasso di tempo: Measured at Year 1
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Measured at Year 1
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The Arizona Social Support Interview Schedule
Lasso di tempo: Measured at Year 1
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Measured at Year 1
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Parenting Stress Index
Lasso di tempo: Measured at Year 1
|
Measured at Year 1
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Caron Zlotnick, PhD, Butler Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R34MH075013 (Sovvenzione/contratto NIH degli Stati Uniti)
- DSIR 83-ATP (NCT00719979)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .