Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services

NCT07837791 | Not Yet Recruiting

• 2 other identifiers: BEAM NDD329335-341400-2000
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression and Anxiety Symptom; Anger; Parenting; Stress (Psychology); Parent Child Relationship; Child Development; Neurodevelopmental Conditions

Keywords

parenting; mental health; anxiety; depression; psychoeducation; ehealth; mhealth

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  From initiation of recruitment through completion of recruitment, approximately 6 months

• Participant retention

  Percentage of enrolled participants who complete the post-intervention assessment

  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

  Throughout the 12-week intervention

• App engagement

  Number of participant interactions with specified BEAM features, including progress-monitoring surveys and forum activity

  Throughout the 12-week intervention

• Parent-coaching attendance

  Number of parent-coaching sessions attended by participants assigned to BEAM

  Throughout the 12-week intervention

Secondary Outcomes (10)

• 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

Study Arms (2)

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.

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.

Interventions

The Building Emotional Awareness and Mental Health (BEAM) Program BEHAVIORAL

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.

The BEAM Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• below the age of 18 years
• parenting a child outside the designated age range
• live outside Manitoba
• have participated in previous iterations of BEAM

Sponsors & Collaborators

• University of Manitoba: lead
• Children's Hospital Research Institute of Manitoba: collaborator
• Kids Brain Health Network: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Related Publications (8)

• 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.

  PMID: 35485930 BACKGROUND

• 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.

  PMID: 36064436 BACKGROUND

• 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.

  PMID: 35815022 BACKGROUND

• 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.

  PMID: 40457257 BACKGROUND

• 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.

  PMID: 36800982 BACKGROUND

• 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.

  PMID: 35188471 BACKGROUND

• 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.

  PMID: 35184262 BACKGROUND

• 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.

  PMID: 38907781 BACKGROUND

Related Links

• BEAM program website

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Central Study Contacts

Leslie E Roos, Associate Professor, PhD

CONTACT

204-474-7400; leslie.roos@umanitoba.ca

Kyla Wiens, BA

CONTACT

chisholk@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)