Life sciences · Interventional Study
ClinicalTrials.gov · September 24, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07837791). This is a study registration, not published results. Lead sponsor: University of Manitoba. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Depression and Anxiety Symptom, Anger, Parenting, Stress (Psychology), Parent Child Relationship, Child Development, Neurodevelopmental Conditions. Interventions: BEHAVIORAL: The Building Emotional Awareness and Mental Health (BEAM) Program. Primary outcome measures: Change in caregiver mental health symptom composite , Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up; Recruitment rate , From initiation of recruitment through completion of recruitment, approximately 6 months; Participant retention , Immediately following the 12-week intervention or services-as-usual period; Program module completion , Throughout the 12-week intervention; App engagement , Throughout the 12-week intervention; Parent-coaching attendance , Throughout the 12-week intervention. Brief summary: Families of children with neurodevelopmental differences (NDDs) experience disproportionately high levels of parenting stress and mental health difficulties, including elevated depression, anxiety, and caregiver burden. These challenges are often compounded by increased caregiving demands, system navigation stress, and limited access to timely, tailored mental health supports. Parental mental health plays a critical role in family functioning and child outcomes; however, existing services for families of children with NDDs are frequently fragmented, inaccessible, or focused primarily on child behavior rather than caregiver well-being. As a result, many caregivers experience unmet mental health needs that persist throughout early and middle childhood. To address this gap, our team developed BEAM (Building Emotional Awareness and Mental Health), an app-based parenting and mental health intervention that integrates psychoeducation, peer support, progress monitoring, and coached support. Clinical trials evaluating BEAM with parents of young children have demonstrated promising improvements in parental depression, anxiety, and parenting stress, as well as reductions in harsh parenting practices. Building on this evidence base, the current trial examines the implementation and outcomes of BEAM delivered as-is to families of children with NDDs (BEAM-NDD), without content adaptation, to evaluate its feasibility and effectiveness within this high-need population. This trial uses a single-arm pre-post design to evaluate BEAM-NDD among parents and caregivers of children with diagnosed or suspected neurodevelopmental differences. Primary aims are to (1) assess feasibility and acceptability of BEAM-NDD, including recruitment, retention, engagement, satisfaction, and perceived unmet needs; (2) examine changes in caregiver mental health and parenting outcomes following program participation; and (3) explore individual differences in engagement and outcomes to identify for whom BEAM-NDD may be more or less effective. Participants will complete a 12-week intervention delivered through the BEAM app, consisting of weekly parenting and mental health videos, progress tracking, a moderated peer forum, and optional peer-coaching support. Assessments will be completed at baseline prior to program initiation (T1), immediately post-intervention (T2), and at follow-up (T3). By evaluating BEAM-NDD within real-world service contexts, this trial aims to determine whether an existing evidence-based digital parenting and mental health intervention can support caregiver well-being among families of children with NDDs without requiring adaptation. Findings will inform the scalability and sustainability of BEAM-NDD as an accessible mental health support for families facing long waitlists, limited specialized services, or geographic barriers to care.