Building Emotional Awareness and Mental Health in Parenting (BEAM): protocol for a parallel-group randomized controlled non-inferiority trial for an app based intervention to improve postpartum mental health and support children’s brain development i

BACKGROUND: Symptoms of depression, anxiety and anger are common amongst parents and are associated with increased risk of offspring mental health problems and differences in child brain development. Many parents do not access treatment, in part due to expense, wait times, and stigma. Increasing access to treatment may improve quality of life for parents and their children. eHealth and peer-supported interventions may offer accessible and effective treatment avenues for parents of young children. The primary aim of this non-inferiority trial is to estimate the effect of the Building Emotional Awareness and Mental Health (BEAM) intervention, a digital and peer-supported mental health and parenting program, administered by trained peer paraprofessionals, on parental depression, anxiety and anger symptoms relative to a treatment-as-usual (TAU) waitlist control group. The secondary aims are to compare child internalizing and externalizing behaviours between BEAM and TAU groups to estimate the effect of the BEAM program on child behavioural outcomes. The final aim is to estimate differences in child structural and functional brain connectivity 6 months post intervention between the BEAM and TAU control groups. METHODS: A two-arm, single-blinded, parallel groups randomized controlled trial (RCT) with a 1:1 allocation ratio and repeated measures will be conducted in Western Canada. Parents and primary caregivers (aged 18 +) who self-report moderate to severe symptoms of anger, anxiety, or depression at time of enrolment and reside in the provinces of British Columbia or Alberta, Canada, will be eligible to participate from the larger Pregnancy During the Pandemic (PdP) cohort and invited to enrol. PdP research coordinator will distribute invitations to individuals who previously consented to be contacted for future studies and meet eligibility criteria. Parents will also be recruited from the community through social media advertisements to reach a total sample of 240 participants. Assessments will be conducted at baseline (T1), post-intervention (T2), and 6 months post treatment (T3) and will include self-report questionnaires, and neuroimaging. DISCUSSION: Findings from this study will provide data on the potential efficacy of the BEAM program in supporting parental mental health, child well-being, and neurodevelopment. Results may inform future large-scale trials and may guide the development of accessible, community-based interventions aimed at improving family mental health and child developmental outcomes. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov on September 20, 2023. The first planned enrolment date was April 24, 2024. The registration number is NCT06046989. https://clinicaltrials.gov/study/NCT06046989.