Preventing Postpartum Depression in Adolescent Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Diagnosis of depression
研究概览
简要总结
The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.
Primary Hypothesis:
- The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.
Secondary Hypotheses: 2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum. 3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.
详细描述
Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health.
Project REACH is a randomized controlled trial, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions.
Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Less than 24 weeks pregnant
- •Not currently being treated for depression
- •Speaks and reads English fluently
排除标准
- •Currently receiving mental health services from a health care provider
- •Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis
研究组 & 干预措施
Experimental
Behavioral: Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.
干预措施: Interpersonal therapy-based treatment (Behavioral)
Control
Behavioral: Standard care Participants assigned to receive standard care will focus on prenatal education including issues associated with pregnancy and postpartum. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.
干预措施: Interpersonal therapy-based treatment (Behavioral)
结局指标
主要结局
Diagnosis of depression
时间窗: within 6 months postpartum
Outcome assessment using KID-SCID
次要结局
- Degree of depressive symptoms(pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52)
研究者
maureen phipps
Study Principal Investigator
Women and Infants Hospital of Rhode Island