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

17 settembre 2026 aggiornato da: Leslie E. Roos, University of Manitoba

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: The Building Emotional Awareness and Mental Health (BEAM) Program

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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in caregiver mental health symptom composite
Lasso di tempo: 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.
Baseline before randomization, immediately following the 12-week intervention or services-as-usual period, and 3-month follow-up
Recruitment rate
Lasso di tempo: From initiation of recruitment through completion of recruitment, approximately 6 months

Number and percentage of screened individuals who enrol in the study
From initiation of recruitment through completion of recruitment, approximately 6 months
Participant retention
Lasso di tempo: 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
Program module completion
Lasso di tempo: 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
App engagement
Lasso di tempo: 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
Parent-coaching attendance
Lasso di tempo: Throughout the 12-week intervention

Number of parent-coaching sessions attended by participants assigned to BEAM
Throughout the 12-week intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in parent depressive symptoms.
Lasso di tempo: 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.
Lasso di tempo: 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
Change in parent anger symptoms.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Change in harsh parenting disciplinary practices.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manitoba

Collaboratori

Children's Hospital Research Institute of Manitoba
Kids Brain Health Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

4 gennaio 2027

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

26 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 settembre 2026

Primo Inserito (Effettivo)

24 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BEAM NDD
  • 329335-341400-2000 (Altro numero di sovvenzione/finanziamento: Kids Brain Health Network (KBHN))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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