ICBT for Maternal Depression: Community Implementation in Head Start
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS).
To address that broad question, the investigators will focus on two sets of scientific questions:
- Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net);
- Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching?
Head Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).
详细描述
Background:
Low income women of childbearing age are at disproportionate risk for depressive syndromes and, despite the availability of efficacious interventions, often do not receive needed treatment. The investigators developed Mom-Net, a remote, coach-facilitated, Internet-based intervention adapted from an empirically-supported cognitive behavioral treatment (CBT) for depression to address the needs of depressed mothers. Two randomized control trials demonstrated Mom-Net to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment. In this project investigators seek to examine whether the reach of the Mom-Net intervention can be expanded by implementing within the Head Start Environment.
Investigators are using a hybrid type 2, Effectiveness-Implementation design to compare two implementation approaches for the delivery of Mom-Net, one with its existing high-intensity coaching approach, and one making use of a low-intensity coaching, designed to provide supportive accountability, but not psychoeducational support. Investigators will follow the Exploration, Preparation, Implementation, and Sustainment process model (EPIS) to guide the evaluation, with the Clinical Trial component primarily constituting the Implementation phase.
Clinical Trial Aims:
- Examine effectiveness and Implementation outcomes of Mom-Net within Head-Start, randomizing agencies to implementation approach (i.e., high- vs low-intensity coaching) and mothers within agency, to either Mom-Net or Treatment as Usual (TAU)/waitlist conditions.
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)
盲法说明
Outcome assessors will be blind to participant condition.
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated symptoms of depression (i.e., Patient Health Questionnaire or Edinburgh Postnatal Depression Scale score at or above 10)
- •Have a child 2-5 years enrolled in a participating Head Start; be able to communicate in English or Spanish.
- •Inclusion Criteria: Child
- •- 2-5 years of age and enrolled in participation Head Start
排除标准
- •Evidence of psychosis or other major mental illness or cognitive disability (observed during recruitment or by HS report) that would interfere with meaningful participation
- •Endorsed score of 3 on final item of the PHQ9 or EPDS indicating frequent thoughts of suicide. Could be enrolled at later date if elevated risk ameliorates
- •Exclusion Criteria: Children
- •No exclusion criteria
研究组 & 干预措施
Mom-Net
Mom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff.
In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later.
干预措施: Mom-Net (Behavioral)
Treatment as Usual/Waitlist
HS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies.
干预措施: Treatment as Usual/Waitlist (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)
Well-established measure of maternal depression with 9 self-report items, each rated on a 0 (not at all) to 3 (nearly every day) scale; total score will be used; interpretation: scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe,and severe depression, respectively. Total score will be used to examine change from baseline to subsequent assessments.
Maternal Engagement (Engage)
时间窗: Change between base-line and 5-month assessments
Number of modules (0-8) and coach calls completed, page views (0-120), and program visits (0- no upper limit). These well-established indices of usage will be collected in real time.
Maternal Acceptability (Modified System Usability Scale)
时间窗: Post intervention ( 5 months)
Implementation Outcome Variable. 14-item scale, rated on a 1-5 response scale. Will examine perceived helpfulness of Mom-Net content, activities, and coach calls. This scale has been used in investigators' prior Mom-Net research. The summed-item total score will be used, with a scale range of 14-70.
Implementation Reach (IReach)
时间窗: End of Implementation in Year 2
Implementation Outcome. Calculated as the number of Mom-Net eligible mothers screened within each agency divided by the number of mothers within each agency initiating Mom-Net intervention with a within-agency range of 0-100%.
Screening Reach (Reach)
时间窗: End of screening in year 2 of implementation
Implementation Outcome. Screening rates will be calculated as the number of PHQ-9 screeners administered within each agency each year divided by the family HS enrollment (with a female-identified parent-figure). The metric will represent the percentage of mothers in each agency who were reached, with a range of 0-100.
次要结局
- Parenting Sense of Competence (PSOC)(Change between Baseline and 5- and 12-month follow-up)
- Child Behavior Checklist Teacher Report Form (C-TRF)(Change between Baseline and 5- and 12-month follow-up)
- 5-item World Health Organization Well-Being Index(Change between Baseline and 2-4 month assessment)
- The Work and Social Adjustment Scale(Change between Baseline and 2-4 month assessment)
- Parent Behavior Inventory (PBI)(Change between Baseline and 5- and 12-month follow-up)
- Child Behavior Checklist (CBCL 1 ½ - 5 years)(Change between Baseline and 5- and 12-month follow-up)
- Aggressive Interpersonal Behavior (Proportion)(Change between Baseline and 2-4 month assessment)
- Positive Interpersonal Behavior (Duration)(Change between Baseline and 2-4 month assessment)
- Aggressive Interpersonal Behavior (Duration)(Change between Baseline and 2-4 month assessment)
- Positive Interpersonal Behavior (Proportion)(Change between Baseline and 2-4 month assessment)