Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children.

BACKGROUND: Since the onset of the COVID-19 pandemic, the worldwide prevalence of maternal depression has risen sharply; it is now estimated that one quarter of mothers experience clinically significant depression symptoms. Exposure to maternal depression during early childhood increases the risk for the development of childhood mental illness (MI) in offspring, with altered parenting practices mediating the association between maternal depression and child outcomes. Dual-generation interventions, which aim to simultaneously treat parent and child mental health, show promise for improving outcomes for mothers with depression and their young children. The Building Regulation in Dual Generations (BRIDGE) program combines Dialectical Behavior Therapy (DBT) and parenting skills training to concurrently treat maternal depression and improve parenting practices. In pilot within-group studies, BRIDGE has led to large reductions in maternal depression and child MI symptoms. The aim of the current study is to evaluate the efficacy of BRIDGE in reducing maternal depression and child MI symptoms (primary outcomes) as well as parenting stress and harsh parenting (secondary outcomes). METHODS: A three-armed randomized control trial with equal group sizes will be conducted to compare the efficacy of (1) BRIDGE (DBT + parenting skills), (2) DBT skills training, and (3) services-as-usual. Participants (n = 180) will be mothers of 3- to 5-year-old children who report elevated depression symptoms. Those randomized to BRIDGE or DBT skills training will complete a 16-week group therapy intervention. Assessments will be administered at pre-intervention(T1) post-intervention (T2), and 6-month follow-up (T3). DISCUSSION: Dual-generation programs offer an innovative approach to prevent the intergenerational transmission of mental illness. The current study will add to the evidence base for BRIDGE by comparing it to a stand-alone mental health intervention and a services-as-usual group. These comparisons will provide valuable information on the relative efficacy of including parenting support in a mental health intervention for parents. The results will contribute to our understanding of how maternal depression affects children's development and how intervening at both a mental health and parenting level may affect child and family outcomes. TRIAL REGISTRATION: Name of registry: Clinical Trials Protocol Registration and Results System; trial registration number: NCT05959538; date of registry: July 24, 2023; available: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05959538.

Building Emotional Awareness and Mental Health (BEAM): an open-pilot and feasibility study of a digital mental health and parenting intervention for mothers of infants.

BACKGROUND: Maternal mental health concerns and parenting stress in the first few years following childbirth are common and pose significant risks to maternal and child well-being. The COVID-19 pandemic has led to increases in maternal depression and anxiety and has presented unique parenting stressors. Although early intervention is crucial, there are significant barriers to accessing care. METHODS: To inform a larger randomized controlled trial, the current open-pilot trial investigated initial evidence for the feasibility, acceptability, and efficacy of a newly developed online group therapy and app-based mental health and parenting program (BEAM) for mothers of infants. Forty-six mothers 18 years or older with clinically elevated depression scores, with an infant aged 6-17 months old, and who lived in Manitoba or Alberta were enrolled in the 10-week program (starting in July 2021) and completed self-report surveys. RESULTS: The majority of participants engaged in each of the program components at least once and participants indicated relatively high levels of app satisfaction, ease of use, and usefulness. However, there was a high level of attrition (46%). Paired-sample t-tests indicated significant pre- to post-intervention change in maternal depression, anxiety, and parenting stress, and in child internalizing, but not externalizing symptoms. Effect sizes were in the medium to high range, with the largest effect size observed for depressive symptoms (Cohen's d = .93). DISCUSSION: This study shows moderate levels of feasibility and strong preliminary efficacy of the BEAM program. Limitations to program design and delivery are being addressed for testing in adequately powered follow-up trials of the BEAM program for mothers of infants. TRIAL REGISTRATION: NCT04772677 . Registered on February 26 2021.

Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18-36 months.

BACKGROUND: The prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic, and pregnant individuals are experiencing concerningly elevated levels of mental health symptoms worldwide. Many individuals may now be at heightened risk of postpartum mental health disorders. There are significant concerns that a cohort of children may be at-risk for impaired self-regulation and mental illness due to elevated exposure to perinatal mental illness. With both an increased prevalence of depression and limited availability of services due to the pandemic, there is an urgent need for accessible eHealth interventions for mothers of young children. The aims of this trial are to evaluate the efficacy of the Building Emotion Awareness and Mental Health (BEAM) app-based program for reducing maternal depression symptoms (primary outcome) and improve anxiety symptoms, parenting stress, family relationships, and mother and child functioning (secondary outcomes) compared to treatment as usual (TAU). METHODS: A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to TAU among a sample of 140 mothers with children aged 18 to 36 months, who self-report moderate-to-severe symptoms of depression and/or anxiety. Individuals will be recruited online, and those randomized to the treatment group will participate in 10 weeks of psychoeducation modules, an online social support forum, and weekly group teletherapy sessions. Assessments will occur at 18-36 months postpartum (pre-test, T1), immediately after the last week of the BEAM intervention (post-test, T2), and at 3 months after the intervention (follow-up, T3). DISCUSSION: eHealth interventions have the potential to address elevated maternal mental health symptoms, parenting stress, and child functioning concerns during and after the COVID-19 pandemic and to provide accessible programming to mothers who are in need of support. This RCT will build on an open pilot trial of the BEAM program and provide further evaluation of this evidence-based intervention. Findings will increase our understanding of depression in mothers with young children and reveal the potential for long-term improvements in maternal and child health and family well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306626 . Registered on April 1, 2022.

Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers.

Background: Families have faced unprecedented challenges during the COVID-19 pandemic, leading to increased maternal mental health problems and barriers to accessing care. Innovative programs are needed to support both maternal mental health and parenting, and to buffer the long-term impacts of stress on young children. Using a patient-oriented approach, our research team aimed to co-develop and pilot test an App-based psychoeducation and social-connection platform: Building Emotional Awareness and Mental Health (BEAM). Methods: The co-development process involved a parent advisory board from conceptualization and design, through to direct participation in the program delivery. The BEAM program includes weekly videos and activities based on Unified Protocol therapy modules and emotion-focused parenting strategies, a weekly telehealth group review session, and access to a private online forum for support from other mothers and clinical coaches. A parallel randomized control trial was conducted across two provinces in Canada. Mothers of preschool children (aged 18-36 months old), with moderate-to-severe depression (Patient Health Questionaire-9 ≥ 10), were recruited online and randomized to either the 10-week BEAM intervention or treatment as usual (TAU) control group. Online surveys (ensuring researcher blinding) included questions about feasibility and acceptability of the program and pre/post self-report measures of mental health, parenting, positive coping and child behavior outcomes. The primary outcome measures were symptoms of depression and parenting stress. Data were analyzed using mixed models and an intention-to-treat approach. Results: 65 participants were randomized, by an online allocation tool, to the BEAM (n = 33) and TAU (n = 32) groups. Engagement was relatively high at the beginning of the program, with 78.8% starting the BEAM App and 70.6% attending ≥1 telehealth session. Most respondents felt socially supported, satisfied with the App, and found it easy to use. Pre-post results indicated interaction effects with greater reductions in overall mental health problems, and specifically anxiety and sleep symptoms, among BEAM vs. control participants. There were also time effects with reductions in depression symptoms across both groups. No significant treatment effects emerged for the other mental health symptoms, parenting problems, positive coping, or child behavior outcomes. Descriptive data are included to highlight possible areas of promise for future large efficacy trials. Technological difficulties and other challenges that may have led to attrition and impacted outcomes are discussed. There were no adverse events related to study participation. Conclusions: The BEAM program has promise as a novel, feasible and acceptable intervention for improving mental health among mothers of young children. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04772677].

Supporting families to protect child health: Parenting quality and household needs during the COVID-19 pandemic.

BACKGROUND: Supportive parenting is critical for promoting healthy child development in the face of stressors, such as those occurring during COVID-19. Here, we address a knowledge gap regarding specific household risk factors associated with parenting quality during the pandemic and incorporate first-person accounts of family challenges and needs. METHODS: Mixed methods were applied to data collected between April 14th - 28th, 2020 from the "Parenting During the Pandemic" survey. Participants included 656 primary caregivers (e.g., mothers, fathers, foster parents) of least one child age 1.5-8 years of which 555 (84.6%) responded to at least one parenting questionnaire. Parenting quality was assessed across stressful, negative, and positive parenting dimensions. Household risk was examined across pandemic- linked (e.g., caregiver depression, unmet childcare needs) and stable factors (i.e., annual income, mental illness history). Significant correlates were examined with regressions in Mplus. Thematic analysis identified caregiver challenges and unmet needs from open-ended questions. FINDINGS: Caregiver depression, higher child parity, unmet childcare needs, and relationship distress predicted lower-quality parenting. Caregiver depression was the most significant predictor across every parenting dimension, with analyses indicating medium effect sizes, ds = .39 - .73. Qualitative findings highlighted severe strains on parent capacities including managing psychological distress, limited social supports, and too much unstructured time. INTERPRETATIONS: Lower quality parenting during COVID-19 is associated with multiple household and pandemic risk factors, with caregiver depression consistently linked to parent- child relationship disruptions. Focused efforts are needed to address caregiver mental health to protect child health as part of the pandemic response.

Stress system reactivity moderates the association between cumulative risk and children's externalizing symptoms.

This study examined children's stress system reactivity via the autonomic nervous system (ANS) and hypothalamic pituitary adrenal axis (HPAA) during an acute stressor as moderators of predicted relations between cumulative risk (CR) and mental health symptoms in a sociodemographically diverse sample of young children (n = 58). We employed a reliable stressor paradigm to allow assessment of individual differences in respiratory sinus arrhythmia (RSA) and pre-ejection period (PEP), indexing ANS reactivity, and salivary cortisol, indexing HPAA reactivity. Children's behaviours were assessed using the Child Behaviour Checklist (CBCL). Cumulative risk was indexed by eight parent-reported sociodemographic and psychosocial risk factors. There was a significant main effect of CR on externalizing but not internalizing behaviours. Significant moderations emerged showing that among children with high CR, less RSA withdrawal during the acute stressor and less cortisol recovery following the stressor were associated with to greater externalizing behaviours. Among children with low CR, RSA and cortisol recovery were unrelated to internalizing or externalizing symptoms. Cortisol and PEP reactivity were not significant moderators. Results highlight the relevance of stress system function for understanding differential susceptibility to the early emergence of externalizing symptoms, linked to cumulative risk exposure.