Идёт набор NCT05142384

ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start

Без фазы С лечением Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mom-Net, Treatment as Usual/Waitlist.
Кому может быть актуально: Состояния в реестре: Depression. Базовые параметры: от 2 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

ICBT for Maternal Depression: Community Implementation in Head Start

Обзор

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: 1. 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); 2. 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).

Подробное описание

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:

1. 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.

1. Compare the two Mom-Net implementation approaches on: 1) implementation outcomes including reach, acceptability, fidelity, and cost; and 2) effectiveness outcomes including self-reported maternal depressive symptoms (primary outcome), parenting behavior, and child emotional and behavioral functioning (secondary outcomes). 2. Examine the effectiveness of each Mom-Net implementation approach relative to TAU on the primary and secondary outcomes listed above. 2. Consistent with an experimental therapeutic approach, investigators will examine the mediating influence of changes in maternal functioning associated with core Mom-Net skills on maternal depressive symptoms. Mediators to be examined include behavior activation, negative cognitive styles, social support, and belief that mood can be regulated. Investigators will also examine the mediating influence of change in maternal depressive symptoms on parenting behavior and child outcomes.

Clinical Trial Protocol

1\. Prior to the Implementation Phase (i.e., clinical trial), participating agencies will be randomized to either high- or low-intensity coaching conditions.

Вмешательства

Поведенческое 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
Комбинированный продукт 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 prov

Первичные конечные точки

Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)]
Maternal Acceptability (Modified System Usability Scale) [Срок оценки: Post intervention ( 5 months)]
Screening Reach (Reach) [Срок оценки: End of screening in year 2 of implementation]
Implementation Reach (IReach) [Срок оценки: End of Implementation in Year 2]
Maternal Engagement (Engage) [Срок оценки: Change between base-line and 5-month assessments]

Вторичные конечные точки (10)

Parent Behavior Inventory (PBI) [Срок оценки: Change between Baseline and 5- and 12-month follow-up]
Parenting Sense of Competence (PSOC) [Срок оценки: Change between Baseline and 5- and 12-month follow-up]
Child Behavior Checklist (CBCL 1 ½ - 5 years) [Срок оценки: Change between Baseline and 5- and 12-month follow-up]
Child Behavior Checklist Teacher Report Form (C-TRF) [Срок оценки: Change between Baseline and 5- and 12-month follow-up]
Aggressive Interpersonal Behavior (Proportion) [Срок оценки: Change between Baseline and 2-4 month assessment]
Aggressive Interpersonal Behavior (Duration) [Срок оценки: Change between Baseline and 2-4 month assessment]
Positive Interpersonal Behavior (Proportion) [Срок оценки: Change between Baseline and 2-4 month assessment]
Positive Interpersonal Behavior (Duration) [Срок оценки: Change between Baseline and 2-4 month assessment]
The Work and Social Adjustment Scale [Срок оценки: Change between Baseline and 2-4 month assessment]
5-item World Health Organization Well-Being Index [Срок оценки: Change between Baseline and 2-4 month assessment]

Критерии участия

Inclusion Criteria: Mothers

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

Exclusion Criteria: Mothers

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