Implementation Randomized Controlled Trial of the Building Emotional Awareness and Mental Health (BEAM) App-Based Program for Families of Children With Neurodevelopmental Disorders: Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Participant retention
研究概览
简要总结
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.
详细描述
Families of children with neurodevelopmental differences (NDDs), including autism spectrum disorder, attention-deficit/hyperactivity disorder, and related developmental conditions, experience substantially elevated rates of caregiver stress, depression, anxiety, and emotional exhaustion compared to parents of typically developing children. These mental health challenges are driven by a combination of factors, including increased caregiving demands, behavioral and regulatory difficulties, uncertainty related to diagnosis and prognosis, financial strain, and the burden of navigating complex service systems. Caregiver mental health is a critical determinant of family functioning, parenting quality, and child outcomes; persistent caregiver distress has been associated with poorer parent-child interactions, reduced parental self-efficacy, and increased risk of adverse child socioemotional outcomes.
Despite the well-documented mental health needs of caregivers of children with NDDs, access to timely and effective mental health supports remains limited. Services are often siloed, child-focused, or delivered through long waitlists, with few interventions directly targeting caregiver emotional well-being. Geographic barriers, cost, time constraints, and a shortage of trained providers further restrict access, particularly for families in rural or underserved communities. As a result, many caregivers do not receive mental health support during critical periods of child development.
BEAM (Building Emotional Awareness and Mental Health) is an app-based parenting and mental health intervention designed to address parental distress through an integrated, skills-based approach. BEAM combines evidence-based psychoeducation, self-monitoring, peer support, and optional coached support to promote emotional regulation, stress management, and positive parenting practices. Previous clinical trials of BEAM with parents of young children have demonstrated improvements in parental depression, anxiety, anger, sleep, and parenting behaviors, supporting its efficacy as a scalable digital mental health intervention.
The present study evaluates BEAM delivered as-is to caregivers of children with NDDs (BEAM-NDD). Rather than adapting program content, this trial focuses on examining the feasibility, acceptability, and outcomes of implementing an existing evidence-based digital intervention within a high-need population. This approach reflects a growing emphasis on implementation science and real-world applicability, assessing whether interventions developed for broader parenting populations can be successfully extended to families of children with neurodevelopmental differences.
BEAM-NDD is delivered over a 12-week period through a secure mobile application. The program includes four core components: (1) weekly parenting and mental health psychoeducational videos, (2) weekly progress tracking of emotional and parenting experiences, (3) a moderated peer discussion forum, and (4) skill-building exercises aligned with weekly content. Video content covers topics such as managing stress and emotional overwhelm, emotion regulation strategies, values-based parenting, and strengthening parent-child relationships. Progress tracking allows caregivers to reflect on changes in mood, stress, and parenting experiences over time, supporting self-awareness and engagement. The peer forum provides opportunities for normalization, shared problem-solving, and social support among caregivers facing similar challenges. Optional peer-coaching support is available to further encourage engagement and application of skills. Participants may invite a co-parent or other primary caregiver to participate concurrently in the program.
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
- 是
入选标准
- •Parent or primary caregiver of a child aged 2 to 10 years (24-120 months) with a diagnosed or suspected neurodevelopmental disorder (e.g., autism spectrum disorder, ADHD, global developmental delay)
- •Aged 18 years or older
- •Reside in Manitoba, Canada
- •Able to read, speak, and understand English
- •Have access to a smartphone or electronic device with internet connectivity
- •Report at least mild or greater emotional distress (depression, anxiety, and/or anger), or be deemed eligible based on clinical judgment due to meaningful distress or impairment
排除标准
- •below the age of 18 years
- •parenting a child outside the designated age range
- •live outside Manitoba
- •have participated in previous iterations of BEAM
研究组 & 干预措施
The BEAM Program Group
Participants randomized to the experimental arm will complete 12 weeks of the BEAM program delivered via a mobile application. The intervention is self-guided, and participants will be encouraged to progress through weekly content at their own pace. Each week of BEAM includes: (a) approximately 12-16 minutes of evidence-based mental health and parenting video content, (b) brief exercises designed to practice and reinforce key skills introduced in the videos, (c) access to a moderated in-app discussion forum to facilitate peer support and shared problem-solving with other caregivers, and (d) a brief in-app survey for weekly progress monitoring of emotional well-being and parenting experiences. Participants will also be able to meet with a parent coach with shared lived experience to discuss program content and how to apply it to parenting and mental health challenges they may be facing.
干预措施: The Building Emotional Awareness and Mental Health (BEAM) Program (Behavioral)
Waitlist Control Group
Participants randomized to the waitlist control group will be informed via email that they have been assigned to the waitlist condition. Along with this notification, they will receive a list of mental health and parenting resources that they may access at their discretion. Participants will be instructed to continue with any existing services or supports as usual during the wait period.
Following completion of the 12-week wait period and post-wait assessments, participants will be offered access to the LightBEAM program. LightBEAM is a self-guided, app-based parenting and mental health intervention derived from BEAM that includes weekly psychoeducational videos, progress tracking, skill-building exercises, and access to a moderated peer discussion forum, but does not include parent-peer coaching.
结局指标
主要结局
Participant retention
时间窗: Immediately following the 12-week intervention or services-as-usual period
Percentage of enrolled participants who complete the post-intervention assessment
Program module completion
时间窗: Throughout the 12-week intervention
Number and percentage of the 12 weekly BEAM modules completed by participants assigned to BEAM
Change in caregiver mental health symptom composite
时间窗: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Caregiver mental health will be assessed using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Patient-Reported Outcomes Measurement Information System Anger Short Form, and Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. Scale scores will be standardized before being combined. For each participant, symptoms exceeding the prespecified threshold at baseline will be weighted according to baseline severity and averaged to produce one composite score. Change in this composite score from baseline will be reported, with lower scores indicating improvement in caregiver mental health symptoms.
Recruitment rate
时间窗: From initiation of recruitment through completion of recruitment, approximately 6 months
Number and percentage of screened individuals who enrol in the study
App engagement
时间窗: Throughout the 12-week intervention
Number of participant interactions with specified BEAM features, including progress-monitoring surveys and forum activity
Parent-coaching attendance
时间窗: Throughout the 12-week intervention
Number of parent-coaching sessions attended by participants assigned to BEAM
次要结局
- Change in parent depressive symptoms.(Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in parent anxiety symptoms.(Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in parent anger symptoms.(Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Changes in parent sleep problems.(Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in parenting stress.(Eligibility screening, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in harsh parenting disciplinary practices.(Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in child behaviour.(Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in parent alcohol use.(Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- Change in parent cannabis use.(Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up)
- 12. Change in child adaptive functioning(Baseline, immediately following the 12-week intervention or services-as-usual period, and 3 months after the intervention or services-as-usual period)
研究者
Leslie E. Roos
Associate Professor
University of Manitoba