Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services
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
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.
調査の概要
状態
詳細な説明
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.
The study uses a single-arm pre-post design to evaluate BEAM-NDD in caregivers of children with diagnosed or suspected neurodevelopmental differences. Data collection occurs at baseline prior to program initiation, immediately following completion of the 12-week intervention, and at follow-up. The primary focus of the trial is on implementation outcomes, including recruitment feasibility, retention, program engagement, and participant satisfaction. Secondary objectives include examining changes in caregiver mental health and parenting-related outcomes following participation in BEAM-NDD. Exploratory analyses will examine individual differences in engagement and outcomes to better understand for whom the intervention may be most effective.
Digital interventions such as BEAM-NDD offer several advantages for families of children with NDDs, including flexibility, reduced barriers related to travel and scheduling, and scalability within existing service systems. However, evidence is needed to determine whether these interventions are acceptable and beneficial for caregivers with complex and chronic stressors. By evaluating BEAM-NDD without content modification, this study will provide important information about the generalizability of evidence-based digital parenting and mental health programs to NDD populations.
Findings from this trial will inform future decisions regarding the scale-up, sustainability, and potential adaptation of BEAM for families of children with neurodevelopmental differences. BEAM-NDD has the potential to function as an accessible mental health support for caregivers facing long waitlists, limited specialized services, or geographic barriers, and may complement existing child-focused interventions by directly addressing caregiver well-being.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Leslie E Roos, Associate Professor, PhD
- 電話番号：204-474-7400
- メール：leslie.roos@umanitoba.ca
研究連絡先のバックアップ
- 名前：Kyla Wiens, BA
- メール：chisholk@myumanitoba.ca
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ
- University of Manitoba
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コンタクト：
- Leslie E Roos, PhD
- 電話番号：204-474-7400
- メール：leslie.roos@umanitoba.ca
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コンタクト：
- Kyla Wiens, BA
- メール：chisholk@myumanitoba.ca
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主任研究者：
- Leslie Roos, PhD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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
Exclusion Criteria:
- below the age of 18 years
- parenting a child outside the designated age range
- live outside Manitoba
- have participated in previous iterations of BEAM
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
The BEAM program builds on mHealth best practices and evidence-based program design principles with the core objectives of improving caregiver mental health and supporting adaptive parenting among families of children with neurodevelopmental differences. Program content draws on transdiagnostic, emotion-focused approaches and third-wave Cognitive Behavioural Therapy principles, including Dialectical Behaviour Therapy and Acceptance and Commitment Therapy. The intervention is delivered through a secure mobile application. BEAM consists of five core components: weekly parenting and mental health psychoeducational videos, weekly progress tracking, a moderated peer discussion forum, parent coaching, and skill-building exercises to reinforce strategies introduced in the video content. The program integrates mental health and parenting skills in a flexible, self-guided format intended to reduce barriers to access while supporting sustained engagement over the 12-week intervention period. |
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介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in caregiver mental health symptom composite
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
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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. |
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
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Recruitment rate
時間枠：From initiation of recruitment through completion of recruitment, approximately 6 months
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Number and percentage of screened individuals who enrol in the study |
From initiation of recruitment through completion of recruitment, approximately 6 months
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Participant retention
時間枠：Immediately following the 12-week intervention or services-as-usual period
|
Percentage of enrolled participants who complete the post-intervention assessment |
Immediately following the 12-week intervention or services-as-usual period
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Program module completion
時間枠：Throughout the 12-week intervention
|
Number and percentage of the 12 weekly BEAM modules completed by participants assigned to BEAM |
Throughout the 12-week intervention
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App engagement
時間枠：Throughout the 12-week intervention
|
Number of participant interactions with specified BEAM features, including progress-monitoring surveys and forum activity |
Throughout the 12-week intervention
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Parent-coaching attendance
時間枠：Throughout the 12-week intervention
|
Number of parent-coaching sessions attended by participants assigned to BEAM |
Throughout the 12-week intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in parent depressive symptoms.
時間枠：Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a self-report measure of depression symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depression 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.
時間枠：Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent anxiety symptoms will be measured using the Generalized Anxiety Disorder questionnaire (GAD-7). The GAD-7 is a self-report measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
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Change in parent anger symptoms.
時間枠：Eligibility screening, baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent anger symptoms will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anger scale. The PROMIS-Anger is a self-report measure of anger symptoms. Total scores range from 5 to 25, with higher scores indicating more 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.
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent sleep problems will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. The PROMIS-Sleep Disturbance is a self-report measure of sleep disturbances. Total scores range from 8 to 40, with higher scores indicating more severe sleep disturbances. |
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
|
Change in parenting stress.
時間枠：Eligibility screening, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parenting stress will be measured using the Parenting Stress Index - 4th Edition - Short Form (PSI-4-SF). The PSI-4-SF is a self-report measure that captures three sources of stress; from parent stress, from a difficult child, and from parent-child interactions. Total scores range from 36 to 180, with higher scores indicating more parenting stress. |
Eligibility screening, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
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Change in harsh parenting disciplinary practices.
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Harsh parenting practices will be measured using 10 items measuring Overreactivity from The Parenting Scale (PS-Overreactivity). The PS-Overreactivity is a self-report measure of parenting behavior and dysfunctional discipline in parents with young children. Total scores range from 10 to 70, with higher scores indicating higher levels of ineffective discipline practices |
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
|
Change in child behaviour.
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Child behaviour will be measured using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report measure of emotional and behavioural problems in children. Total scores range from 0 to 198, with higher scores indicating more emotional and behavioural challenges. |
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
|
Change in parent alcohol use.
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent anxiety symptoms will be measured using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a self-report measure of alcohol consumption frequency, drinking behaviors, and frequency of alcohol-related psychological features. Total scores range from 0 to 40, with higher scores indicating more severe alcohol use problems. |
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
|
Change in parent cannabis use.
時間枠：Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
|
Parent anxiety symptoms will be measured using the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). The CUDIT-R is a self-report measure of cannabis consumption frequency, problems, dependence, and cannabis-related psychological features. Total scores range from 0 to 40, with higher scores indicating more severe cannabis use problems. |
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
時間枠：Baseline, immediately following the 12-week intervention or services-as-usual period, and 3 months after the intervention or services-as-usual period
|
Child adaptive functioning will be assessed using the age-appropriate parent-report form of the Adaptive Behavior Assessment System, Third Edition (ABAS-3): the Parent/Primary Caregiver Form for Ages 0-5 or the Parent Form for Ages 5-21. The ABAS-3 assesses everyday adaptive functioning across conceptual, social, and practical domains. The General Adaptive Composite standard score will be reported. Standard scores range from 40 to 160, with higher scores indicating stronger 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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- MacKinnon AL, Simpson KM, Salisbury MR, Bobula J, Penner-Goeke L, Berard L, Rioux C, Giesbrecht GF, Giuliano R, Lebel C, Protudjer JLP, Reynolds K, Sauer-Zavala S, Soderstrom M, Tomfohr-Madsen LM, Roos LE. Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. Front Psychiatry. 2022 Jun 24;13:880972. doi: 10.3389/fpsyt.2022.880972. eCollection 2022.
- MacKinnon AL, Silang K, Penner K, Zalewski M, Tomfohr-Madsen L, Roos LE. Promoting Mental Health in Parents of Young Children Using eHealth Interventions: A Systematic Review and Meta-analysis. Clin Child Fam Psychol Rev. 2022 Sep;25(3):413-434. doi: 10.1007/s10567-022-00385-5. Epub 2022 Feb 20.
- Silang KA, Sohal PR, Bright KS, Leason J, Roos L, Lebel C, Giesbrecht GF, Tomfohr-Madsen LM. eHealth Interventions for Treatment and Prevention of Depression, Anxiety, and Insomnia During Pregnancy: Systematic Review and Meta-analysis. JMIR Ment Health. 2022 Feb 21;9(2):e31116. doi: 10.2196/31116.
- Xie EB, Freeman M, Penner-Goeke L, Reynolds K, Lebel C, Giesbrecht GF, Rioux C, MacKinnon A, Sauer-Zavala S, Roos LE, Tomfohr-Madsen L. 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. Pilot Feasibility Stud. 2023 Feb 18;9(1):27. doi: 10.1186/s40814-023-01245-x.
- Xie EB, Simpson KM, Reynolds KA, Giuliano RJ, Protudjer JLP, Soderstrom M, Sauer-Zavala S, Giesbrecht GF, Lebel C, Mackinnon AL, Rioux C, Penner-Goeke L, Freeman M, Salisbury MR, Tomfohr-Madsen L, Roos LE. 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. Trials. 2022 Sep 5;23(1):741. doi: 10.1186/s13063-022-06512-5.
- Tomfohr-Madsen LM, Roos LE, Madsen JW, Leason J, Singla DR, Charlebois J, Tomasi P, Chaput KH. Peer-Led Psychotherapy: The Time Is Now. J Clin Psychiatry. 2022 Apr 27;83(3):21lr14366a. doi: 10.4088/JCP.21lr14366a. No abstract available.
- Simpson KM, McHardy RJW, Zhou JG, Levasseur-Puhach S, Cote CM, Braun M, Clement F, MacKinnon AL, Nickel N, Afifi TO, Giesbrecht GF, Giuliano R, Katz LY, Kelly LE, Klassen TP, Lebel C, Mushquash A, Reynolds K, Decaire E, Mughal W, Chartrand F, Kloss O, Hensel JM, Bolton JM, Unger JAM, Archibald M, Fisher P, Pharazyn A, Tomfohr-Madsen L, Roos LE. Building Emotional Awareness and Mental Health (BEAM): study protocol for a hybrid implementation-effectiveness trial of the BEAM app-based program for parents with clinical mental health problems. BMC Psychiatry. 2025 Jun 2;25(1):567. doi: 10.1186/s12888-025-06964-4.
- Penner KE, Roy R, Hanlon-Dearman AC, Cheung K, Katz C, Schleider JL, Roos LE, Cameron EE. "Bottom of My Own List:" Barriers and Facilitators to Mental Health Support Use in Caregivers of Children with Neurodevelopmental Support Needs. J Autism Dev Disord. 2025 Sep;55(9):3288-3303. doi: 10.1007/s10803-024-06409-z. Epub 2024 Jun 22.
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BEAM NDD
- 329335-341400-2000 (その他の助成金/資金番号：Kids Brain Health Network (KBHN))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Summary statistics (e.g., questionnaire subscales, sociodemographics, aggregated forum usage data) paired with non-identifiable participant IDs may be shared on data repositories such as the Open Science Framework.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。