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临床试验/NCT06046989
NCT06046989招募中不适用

BEAM: Building Emotional Awareness and Mental Health in Parenting. An App-based Intervention to Improve Parental Mental Health and Support Children's Brain Development.

University of Calgary3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
3
主要终点
Changes in parental mental health

研究概览

简要总结

Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. If left untreated, these disorders can be long-lasting and lead to child behaviour problems, brain changes, and risk for later mental illness. We developed an app-based treatment for parental mental illness: Building Emotional Awareness and Mental Health in Parenting (BEAM). The BEAM program includes mental health and parenting videos, peer coaching, as well as a forum and drop-in Zoom sessions where parents can connect with each other to receive and provide social support. The program is supported by peer coaches (parents with lived experience of recovery from mental illness and who may have received emotion-focused parenting support) and supervised by clinically-trained staff. Peer coaches check-in with parents weekly to support their progress. Our study will see the BEAM app's effect on parent mental health, parenting stress, child behaviour, and child brain structure and function. 240 parents with high depression, anxiety, and/or anger symptoms will be recruited, with half forming the treatment-as-usual group.

详细描述

Although there are existing treatments for parental mental illness, there can be barriers to accessing care such as high cost and limited options in rural areas. This is troubling as untreated parental mental health symptoms can contribute to adverse consequences for both the parent and child. Thus, early intervention is critical to help prevent negative long-term effects. Digital resources can provide effective support, as they bypass many of the barriers associated with in-person interventions. The BEAM app was designed to combat these barriers and assist parents struggling with their mental health and the transition to parenthood. BEAM is a 12-week intervention with weekly videos about mental health and parenting for participants to watch. Exercises will be available so participants can practice new skills. Participants will also participate in weekly check-ins with peer coaches and have access to a secure forum where they can talk to other participants and receive social support. The BEAM Program also includes optional monthly drop-in sessions where parents can connect with each other in real time over Zoom.

Parent mental health (depression, anxiety, anger), parenting stress, and overreactive parenting will be assessed pre- and post-intervention, as well as 6 months post-intervention. Child behaviour and mental health will also be measured at all three timepoints (pre-, post-, and 6-months post-intervention). Child brain structure and function will be examined by MRI scans 6-months post-intervention. Participants will also receive brief wellness monitoring surveys in-app on a weekly basis.

There are three objectives for the present study:

  1. Examine the effects of the BEAM program on parent mental health (including symptoms of depression, anxiety, and anger).
  2. Examine the effects of the BEAM program on children's behaviour and mental health.
  3. Examine the effects of the BEAM program on children's brain structure and function.

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

Research assistants who are conducting the MRI brain imaging will be blinded to the participants' condition (i.e., whether they are in the control or experimental group).

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent is 18 years of age or older
  • Must have a child who is 3-4 years old
  • Must show clinically elevated symptoms of depression, anxiety, &/or anger
  • Living in the Vancouver or Calgary area
  • Parent is comfortable understanding, speaking, and reading English

排除标准

  • Parent is under the age of 18
  • Does not show clinically elevated symptoms of depression, anxiety, and/or anger
  • History of attempted suicide or self-harm in the past 6 months
  • Does not live in the Vancouver or Calgary area
  • Child has serious genetic, neurological, or neurodevelopmental disorders that impact cognitive function or brain structure/function (e.g., Down Syndrome, epilepsy, etc.), or if they have contra-indications to MRI scanning (i.e., metal implants)

结局指标

主要结局

Changes in parental mental health

时间窗: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

Parent mental health will be a composite of symptoms of depression, anxiety, and anger. Depression symptoms will be measured via the 10-item Center for Epidemiologic Studies Depression Scale (CES-D; scores range from 0-30 with higher score indicating more severe symptoms). Clinically elevated depressive symptoms will be identified with a cut-off of \>10. Anxiety symptoms will be measured via the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form (raw scores range from 7-35 with higher scores indicating more severe symptoms). Parent anger will be measured via PROMIS Anger (raw scores range from 5-25 with higher scores indicating more anger). T-score cut-offs of \>60 will be used to identify those with clinically elevated anger and anxiety symptoms. An aggregate variable for parent mental health symptoms will be computed by converting scores on the CES-D, PROMIS Anxiety, and PROMIS Anger to standardized z-scores and then taking their average.

次要结局

  • Children's phonological processing(To be assessed 6 months post-intervention)
  • Changes in children's behaviour(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Changes in parenting stress(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Changes in relationship satisfaction(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Changes in household environment(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Changes in parent self-efficacy(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Changes in parental sleep(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Adverse childhood experiences(To be assessed at pre-intervention)
  • Changes in discipline practices(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Children's speeded naming ability(To be assessed 6 months post-intervention)
  • Changes in children's mental health and development(To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention)
  • Children's structural brain connectivity(To be assessed 6 months post-intervention)
  • Children's functional brain connectivity(To be assessed 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lianne Tomfohr-Madsen

Associate Professor

University of British Columbia

研究点 (3)

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