Building Emotion Awareness and Mental Health (BEAM): Randomized Controlled Trial for Mothers of Children 18-36 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in depression symptoms
研究概览
简要总结
During the COVID-19 pandemic, the prevalence of maternal depression and anxiety has increased and research suggests that the cognitive development of children born during the pandemic has been impacted. There are significant concerns that a cohort of children may be at-risk for mental illness and impaired self-regulation due to elevated exposure to perinatal maternal mental illness. Intervention is crucial as the intergenerational effects of maternal mental illness are most pronounced when mental health concerns persist. There is currently an urgent need for accessible eHealth interventions for mothers of young children as the pandemic has contributed to an increased prevalence of mental health concerns and to additional barriers to services. The Building Emotion Awareness and Mental Health (BEAM) app-based program was developed to help address maternal mental health concerns and parenting stress. A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to treatment as usual (TAU) among a sample of 140 mothers who self-report moderate-to-severe symptoms of depression and/or anxiety and have a child 18 to 36 months-old.
详细描述
Maternal mental health symptoms in the first few years following childbirth are common and can have contributed to adverse consequences for both mother and baby. Two of the most common perinatal mental health concerns are depression and anxiety. The COVID-19 pandemic has introduced heightened stressors for families, including physical isolation from support and social networks, additional childcare responsibilities, and economic uncertainty. Unsurprisingly, the pandemic has also led to an increased prevalence of maternal depression and anxiety in Canada and around the world. These mental health problems are associated with increased health problems and low quality of life for mothers. The COVID-19 pandemic has also posed additional challenges to families and mothers with young children are experiencing heightened parenting stress, increasing their support needs. For mothers with depression, these additional parenting stressors can worsen the symptoms and severity their depression. Furthermore, emerging research suggests that the COVID-19 pandemic has had detrimental effects on early child cognitive development.
According to the developmental origins of health and disease, exposure to maternal depression in the first 5 years of life is linked to children's mental illness, cognitive impairments, and developmental delays. Intervening early is important to help prevent negative long-term consequences for mothers and their children. Without treatment, maternal depressive symptoms tend to remain consistent throughout the preschool years and the adverse consequences of maternal mental health concerns are most pronounced when depression persists. Although there are evidence-based treatments to address maternal mental illness, accessing care can be challenging due to the exceedingly high barriers to service due to COVID-19, such as lack of childcare and time.
Web-based resources have been identified as a preference for mental health support by mothers with mental health problems during the perinatal period. Furthermore, mothers have expressed appreciation for peer support during the perinatal period as social support is often highly relied upon in the postnatal period to care for their infants and themselves. Support from other mothers, specifically, has been found to be helpful in recovering from postpartum depression and individuals report higher satisfaction in treatments of postpartum depression that include a peer support component.
E-health interventions, designed to target both maternal mental illness and parenting abilities, and that prioritize social support, may be a promising avenue to address the intergenerational impact of perinatal mental health problems. The Building Emotion Awareness and Mental Health (BEAM) program is an app-based and online group therapy program that was developed to respond to the high needs of mothers managing depression, anxiety, and parenting stress.
There are 3 objectives for this study:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A mother with a child aged 18-36 months old
- •Moderate-to-severe symptoms of depression and/or anxiety (i.e., a score at or above 10 on the Patient Health Questionnaire and/or the General Anxiety Disorder scale
- •Comfortable understanding, speaking, and reading English
- •Live in Manitoba or Alberta, Canada
- •Be available to attend weekly telehealth sessions
- •Consent to wearing a Fitbit
- •Complete baseline screener and questionnaire and be willing to meet the research team through Zoom (either during assessment or technology check in session).
排除标准
- •Child is outside of the 18-36 month age range
- •Does not meet criteria for moderate-to-severe depression and/or anxiety
- •Lives outside of Manitoba or Alberta
- •A reported history of attempted suicide in the past year or self-harm in the past 6 months
研究组 & 干预措施
The BEAM program group
The BEAM Program is delivered via mobile application and weekly group telehealth sessions. BEAM includes approximately 20 minutes of weekly asynchronous video modules on parenting and mental health. Mental Health videos will provide information and emotion-regulation strategies that draw from the Unified Protocol, an evidence-based treatment for depression and anxiety disorders. Self-compassion and effective communication will also be central focuses of the mental health content. Supportive parenting videos will provide parents with emotion-focused parenting strategies and help parents understand and respond to their children's challenging emotions and behaviours. The weekly group telehealth sessions will allow participants to discuss content and ask questions, with the purpose of increasing a sense of community and social support. The online community forum will provide a space for participants to reflect on their learned skills and connect with other participants in the program.
干预措施: Building Emotion Awareness and Mental Health (BEAM) (Behavioral)
Treatment as usual group
The treatment as usual (TAU) control arm of the study is designed to account for the potential effects of time on depression symptoms.
结局指标
主要结局
Change in depression symptoms
时间窗: The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Symptoms of depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a self-administered questionnaire with possible scores ranging from 0 to 27, where higher scores are indicative of more severe symptoms. A cut-off score of ≥ 10 will be used to identify participants who present with clinically concerning symptoms of depression.
次要结局
- Change in sleep problems(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in parental assistance with child emotion regulation(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in partner social support(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in romantic relationship satisfaction(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in parenting stress(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in parenting discipline practices(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in parenting behaviours(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in anxiety symptoms(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in anger(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in self-compassion(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in suicidal ideation severity(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in self-esteem(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in alcohol use(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in cannabis use(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in child emotional and behavioural problems(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))
- Change in child temperament(To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3))