Depression and Anxiety SymptomNCT07837791
Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services
A study testing The Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression and Anxiety Symptom and Anger, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression and Anxiety Symptom, Anger, Parenting
- What is being tested?
- The Building Emotional Awareness and Mental Health (BEAM) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2027to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- below the age of 18 years
- parenting a child outside the designated age range
- live outside Manitoba
- have participated in previous iterations of BEAM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyla Wiens, BA contact
Canada1 site
University of Manitoba
Winnipeg, Manitoba
Leslie E Roos, PhD, 204-474-7400, leslie.roos@umanitoba.ca
Kyla Wiens, BA, chisholk@myumanitoba.ca
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Depression and Anxiety Symptom, Anger, Parenting, Stress (Psychology), Parent Child Relationship, Child Development
- Being tested
- The Building Emotional Awareness and Mental Health (BEAM) Program
- Keywords
- parenting, mental health, anxiety, depression, psychoeducation, ehealth, mhealth
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Building Emotional Awareness and Mental Health (BEAM) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The BEAM Program Group | Experimental | 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. Receives: Behavioral: The Building Emotional Awareness and Mental Health (BEAM) Program |
| Waitlist Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver mental health symptom composite
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.
Measured: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Recruitment rate
Number and percentage of screened individuals who enrol in the study
Measured: From initiation of recruitment through completion of recruitment, approximately 6 months
Participant retention
Percentage of enrolled participants who complete the post-intervention assessment
Measured: Immediately following the 12-week intervention or services-as-usual period
Program module completion
Number and percentage of the 12 weekly BEAM modules completed by participants assigned to BEAM
Measured: Throughout the 12-week intervention
App engagement
Number of participant interactions with specified BEAM features, including progress-monitoring surveys and forum activity
Measured: Throughout the 12-week intervention
Parent-coaching attendance
Number of parent-coaching sessions attended by participants assigned to BEAM
Measured: Throughout the 12-week intervention
Secondary outcomes (10)
Change in parent depressive symptoms.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parenting stress.
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.
Measured: Eligibility screening, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in harsh parenting disciplinary practices.
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
Measured: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in child behaviour.
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.
Measured: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parent alcohol use.
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.
Measured: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parent cannabis use.
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.
Measured: 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
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.
Measured: Baseline, immediately following the 12-week intervention or services-as-usual period, and 3 months after the intervention or services-as-usual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start4 Jan 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depression and Anxiety SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a randomized pre-post interventional study design, participants will be randomized in a 1:1 allocation to either the BEAM-NDD intervention or a waitlist control condition following completion of baseline measures. Participants randomized to the intervention arm will receive immediate access to the 12-week BEAM-NDD program delivered via a mobile application, while those assigned to the waitlist control condition will continue with usual care during the initial study period. After the 3-month follow up surveys have been completed, participants in the waitlist control group will be granted access to the LightBEAM program. Longitudinal self-report questionnaires will be administered digitally at eligibility (T0) prior to randomization, pre-intervention (T1), immediately post-intervention or equivalent waitlist period (T2), and at follow-up (T3).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Kids Brain Health Network
- Responsible party
- Principal investigator, Leslie E. Roos, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837791
- Sponsor's protocol ID
- BEAM NDD
- Other IDs
- 329335-341400-2000
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35485930Xie 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.
PubMed 36064436MacKinnon 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.
PubMed 35815022Simpson 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.
PubMed 40457257Xie 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.
PubMed 36800982Silang 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.
PubMed 35188471MacKinnon 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.
PubMed 35184262Penner 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.
PubMed 38907781
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07837791
- Acronym / sponsor ID
- BEAM NDD
- Conditions
- Depression and Anxiety Symptom, Anger, Parenting, Stress (Psychology), Parent Child Relationship, Child Development
- Keywords
- parenting, mental health, anxiety, depression, psychoeducation, ehealth, mhealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Children's Hospital Research Institute of Manitoba, Kids Brain Health Network
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a randomized pre-post interventional study design, participants will be randomized in a 1:1 allocation to either the BEAM-NDD intervention or a waitlist control condition following completion of baseline measures. Participants randomized to the intervention arm will receive immediate access to the 12-week BEAM-NDD program delivered via a mobile application, while those assigned to the waitlist control condition will continue with usual care during the initial study period. After the 3-month follow up surveys have been completed, participants in the waitlist control group will be granted access to the LightBEAM program. Longitudinal self-report questionnaires will be administered digitally at eligibility (T0) prior to randomization, pre-intervention (T1), immediately post-intervention or equivalent waitlist period (T2), and at follow-up (T3).
| Arm | Type | Receives |
|---|---|---|
| The BEAM Program Group | Experimental | Behavioral: The Building Emotional Awareness and Mental Health (BEAM) ProgramParticipants 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. |
| Waitlist Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- below the age of 18 years
- parenting a child outside the designated age range
- live outside Manitoba
- have participated in previous iterations of BEAM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Building Emotional Awareness and Mental Health (BEAM) ProgramThe 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. | Behavioural | The BEAM Program Group |
Primary outcome
Change in caregiver mental health symptom composite
Time frame: 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
Time frame: From initiation of recruitment through completion of recruitment, approximately 6 months
Number and percentage of screened individuals who enrol in the study
Participant retention
Time frame: Immediately following the 12-week intervention or services-as-usual period
Percentage of enrolled participants who complete the post-intervention assessment
Program module completion
Time frame: Throughout the 12-week intervention
Number and percentage of the 12 weekly BEAM modules completed by participants assigned to BEAM
App engagement
Time frame: Throughout the 12-week intervention
Number of participant interactions with specified BEAM features, including progress-monitoring surveys and forum activity
Parent-coaching attendance
Time frame: Throughout the 12-week intervention
Number of parent-coaching sessions attended by participants assigned to BEAM
10 secondary outcomes
Change in parent depressive symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parenting stress.
Time frame: Eligibility screening, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in harsh parenting disciplinary practices.
Time frame: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in child behaviour.
Time frame: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parent alcohol use.
Time frame: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Change in parent cannabis use.
Time frame: 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
Time frame: Baseline, immediately following the 12-week intervention or services-as-usual period, and 3 months after the intervention or services-as-usual period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 35485930Tomfohr-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.
- Background: PubMed 36064436Xie 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.
- Background: PubMed 35815022MacKinnon 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.
- Background: PubMed 40457257Simpson 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.
- Background: PubMed 36800982Xie 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.
- Background: PubMed 35188471Silang 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.
- Background: PubMed 35184262MacKinnon 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.
- Background: PubMed 38907781Penner 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.
- BEAM program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyla Wiens, BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Building Emotional Awareness and Mental Health (BEAM) Program in people with Depression and Anxiety Symptom and Anger, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie E Roos, Associate Professor, PhD (204-474-7400, leslie.roos@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver mental health symptom composite (time frame: Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837791, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.