Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
研究概览
简要总结
Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First-time, English-speaking mothers of healthy singleton newborns
- •Positive screen (> 10) on Edinburgh Postnatal Depression Scale
排除标准
- •Suicidal ideation
- •Currently receiving depression treatment
- •Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder
结局指标
主要结局
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
时间窗: 3 months (post-intervention) and 6 months (follow-up)
Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
时间窗: baseline, 3 months (post-intervention) and 6 months (follow-up)
Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale
时间窗: baseline, 3 months (post-intervention) and 6 months (follow-up)
次要结局
- Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)(baseline, 3 months (post-intervention) and 6 months (follow-up))
- Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)(baseline, 3 months (post-intervention), 6 months (follow-up))
- Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)(3 months (post-intervention) and 6 months (follow-up))
研究者
Janice H. Goodman
Associate Professor
Spaulding Rehabilitation Hospital