Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
研究概览
简要总结
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.
详细描述
This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.
The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.
Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother of a 0 to 5-year-old Head Start child
- •Mother speaks English or Spanish
排除标准
- •Mother with suicidal ideation
- •Mother with cognitive limitation
研究组 & 干预措施
Usual care control group
Families in the control group will receive usual Head Start services.
干预措施: Usual care (Behavioral)
Stepped-care intervention (SCI) group
In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.
干预措施: Problem-solving education (PSE) (Behavioral)
Stepped-care intervention (SCI) group
In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.
干预措施: Engagement sessions (Behavioral)
结局指标
主要结局
Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
时间窗: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms (QIDS) will be used to assess the incidence of moderate to severe depressive symptom episodes, as defined by a QIDS score ≥ 11. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms.
Change in the mean maternal depressive symptoms based on the QIDS
时间窗: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms will be used to assess depressive symptoms. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms. The mean QIDS scores will be calculated for the baseline and each follow up period.
次要结局
- Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription(2, 4, 6, 8, 10, 12 months)
- Social Skills Improvement System - Rating Scales(baseline; 6, 12 months)
- Bracken School Readiness Assessment(baseline; 6, 12 months)
- Rate of participants who received primary-care based services(2, 4, 6, 8, 10, 12 months)
- Burden of illness for depression(baseline; 6, 12 months)
- Child absenteeism from Head Start(baseline; 6, 12 months)
- Caregiver-Teacher Report Form(baseline; 6, 12 months)
- Perceived Stress(baseline, 4, 8, 12 months)
- Family Conflict(Baseline, 6, 12 months)
- Behavioral Activation for Depression(baseline, 4, 8, 12 months)
- Coping Strategies(baseline, 4, 8, 12 months)
- Parent-Child Interaction(baseline, 6, 12 months)
- Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription(Baseline, 2, 4, 6, 8, 10, 12 months follow-up)
- Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription(2, 4, 6, 8, 10, 12 months)