Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455397
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-29
Brief Title:
Building Emotional Awareness and Mental Health BEAM 2024-2027
Sponsor:
Leslie E Roos
Organization:
University of Manitoba
Study Overview
Official Title:
Implementing BEAM An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAM
Brief Summary:
Children are highly sensitive to adversity during their first five years of life with exposure to chronic parental mental illness MI consistently linked to socio-emotional impairments and mental health problems in children Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress with parental MI reported at three times the pre-pandemic rates This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children In response the investigators developed the Building Emotional Awareness and Mental Health BEAM program an innovative mobile health mHealth solution for parents of young children Clinical trials to date evaluating BEAM have shown promising results demonstrating reductions in parent depression anxiety and harsh parenting practices This trial involves an effectiveness-implementation hybrid design with co-primary aims of 1 determining BEAMs effectiveness in improving child mental health and developmental outcomes and 2 evaluating the implementation of BEAM in the community through metrics such as feasibility acceptability and uptake The secondary aim of this trial is to measure BEAMs effectiveness in improving long-term biopsychosocial family outcomes using administrative data A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming
This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months Study participants will complete 12 weeks of psychoeducation modules in the BEAM app with access to an online social support forum and check ins with a peer coach Assessments of parent and child symptoms will occur at pre-test before BEAM begins T1 immediately after the last week of the BEAM intervention post-test T2 6-month follow-up T3 and 12-month follow-up T4
The BEAM program offers a promising solution to addressing elevated parental mental health symptoms parenting stress and related child functioning concerns The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program in a next step of testing BEAMs readiness for nationwide scaling
This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months Study participants will complete 12 weeks of psychoeducation modules in the BEAM app with access to an online social support forum and check ins with a peer coach Assessments of parent and child symptoms will occur at pre-test before BEAM begins T1 immediately after the last week of the BEAM intervention post-test T2 6-month follow-up T3 and 12-month follow-up T4
The BEAM program offers a promising solution to addressing elevated parental mental health symptoms parenting stress and related child functioning concerns The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program in a next step of testing BEAMs readiness for nationwide scaling
Detailed Description:
The initial five years of a childs life mark a critical developmental phase and a period of high sensitivity to environmental stressors including the impact of parental mental illness MI and parenting stress Research has consistently linked parental MI with a broad range of child-related issues including irritability sleep disturbances and socio-emotional developmental impairments These adverse outcomes are often attributed to environmental factors including parental modeling of maladaptive emotion coping strategies such as avoidance and aggression and harsh parenting practices characterized by reactive discipline and conflictual interactions Notably when parental MI is accompanied by additional stressors such as domestic conflict or financial strains the long-term risks for children are exacerbated Further the chronicity of parental MI has critical implications for children When stressors and parental MI are persistent the risk of adverse developmental outcomes for children increases putting children at heightened risk for stress and development of their own psychopathology This highlights the critical need for interventions that address parental MI and the broader spectrum of parenting stress and its multifaceted impacts on children
Despite the need for parents to improve their stress and mental health symptoms the majority of parents do not access evidence-based treatments Previous research has documented many barriers preventing parents from accessing care These barriers include service backlogs long waitlists high costs of individual therapy lack of information of where to access interventions and overwhelming childcare demands Additionally although evidence-based treatments exist most interventions do not comprehensively address the mental health of both parents and children This gap in services is significant given meta-analytic evidence indicating that dual-generation programs which simultaneously target parent MI and child well-being yield impacts that are 50 larger in promoting positive child outcomes compared to programs focused solely on addressing parental MI There is a clear need to provide accessible and scalable solutions that promote positive mental health and developmental outcomes in at-risk children Digital mental health interventions offer a potential avenue for addressing family needs and barriers to care that are an accessible and low-cost option and research shows great promise for treating adult depression using these methods Additional emerging research highlights the efficacy of app-based programs in improving parental MI and parent-child interactions However very limited existing app-based or mHealth programs address both parental mental health and parenting skills which indirectly targets child well-being
In response to this need the investigators conducted qualitative research ie focus groups and individual interviews with parents with lived experience and consulted with a parent advisory board to co-develop a program that simultaneously addressed parental MI and parenting Results suggested that parents wanted accessible online services grounded in expert research Alongside patient-partners and community providers the investigators then developed the BEAM Building Emotional Awareness and Mental Health app-based program The BEAM program is aligned with best practices in mHealth programs including patient-driven priorities rapid-cycle iterations to facilitate continual improvements and a commitment to evidenced-based care Key elements of the original BEAM program include 1 expert-led educational videos using transdiagnostic therapy and emotion-focused parenting strategies 2 brief group sessions to consolidate therapeutic content and build social support 3 a community forum to enhance social connection and 4 symptom monitoring to track progress In case of a mental health or parenting-related crisis clinical coaches also consult via phone BEAM builds on evidence from the investigative teams knowledge synthesis work suggesting that mHealth therapeutics can address parent MI and while appealing to parents
The BEAM intervention has consistently demonstrated promising outcomes across various trials to date The investigative teams latest phase II RCT with mothers of toddlers found that the BEAM program outperformed a services-as-usual SAU control condition Significant improvements in parental MI symptoms including anxiety anger and alcohol use were observed Additionally BEAM was effective in reducing harsh parenting practices and negative parent-child interactions with substantial improvements observed for families living in poverty This trial also showed noteworthy participant engagement with retention rates 84 comparable to in-person therapy sessions This phase of research built on and replicated the success of earlier trials with both an open pilot and pilot RCT demonstrating BEAMs efficacy in reducing MI symptoms such as depression anxiety anger sleep issues and substance use Qualitative feedback from the initial trials emphasized the positive impact of the BEAM program on mental health and parenting leading to enhanced quality of life and improved family relationships Participants also highlighted the value of the social support gained through the online community
To further address family mental health needs this trial will test the readiness of the BEAM program for scalability The current study involves a hybrid effectiveness-implementation trial design to build on previous work The investigators will use both effectiveness and implementation metrics including short-term follow ups of primary outcomes alongside longer-term follow-ups of mental health and socio-developmental outcomes with linked administrative data This hybrid design follows the type 2 model in which effectiveness and implementation are co-primary aims and can be tracked simultaneously as the trial progresses This approach is consistent with the investigative teams rapid-cycle program development to date in which BEAM has been tested and adapted in response to patient and provider feedback through each iteration
This implementation trial aims to maximize BEAMs accessibility equitability and effectiveness for future nation-wide implementation For the current implementation trial the investigators conducted a full App rebuild to create BEAM Version 20 based on participant and Parent Advisory Board feedback BEAM 20 updates include improvements to psychoeducational video content eg high-quality video production animations closed captioning the mobile application user experience eg push notifications direct messaging integrated video player that adjusts video quality based on available bandwidth easy-to-navigate platform and functionality across mobile device operating systems iOS Android The weekly psychoeducational videos short symptom tracking surveys and social support community forum are now housed seamlessly within the BEAM app Other aspects of the program include individual check ins with trained peer coaches group drop-in sessions and a connection to a systems navigator whose role will be to support participants in accessing community resources
Despite the need for parents to improve their stress and mental health symptoms the majority of parents do not access evidence-based treatments Previous research has documented many barriers preventing parents from accessing care These barriers include service backlogs long waitlists high costs of individual therapy lack of information of where to access interventions and overwhelming childcare demands Additionally although evidence-based treatments exist most interventions do not comprehensively address the mental health of both parents and children This gap in services is significant given meta-analytic evidence indicating that dual-generation programs which simultaneously target parent MI and child well-being yield impacts that are 50 larger in promoting positive child outcomes compared to programs focused solely on addressing parental MI There is a clear need to provide accessible and scalable solutions that promote positive mental health and developmental outcomes in at-risk children Digital mental health interventions offer a potential avenue for addressing family needs and barriers to care that are an accessible and low-cost option and research shows great promise for treating adult depression using these methods Additional emerging research highlights the efficacy of app-based programs in improving parental MI and parent-child interactions However very limited existing app-based or mHealth programs address both parental mental health and parenting skills which indirectly targets child well-being
In response to this need the investigators conducted qualitative research ie focus groups and individual interviews with parents with lived experience and consulted with a parent advisory board to co-develop a program that simultaneously addressed parental MI and parenting Results suggested that parents wanted accessible online services grounded in expert research Alongside patient-partners and community providers the investigators then developed the BEAM Building Emotional Awareness and Mental Health app-based program The BEAM program is aligned with best practices in mHealth programs including patient-driven priorities rapid-cycle iterations to facilitate continual improvements and a commitment to evidenced-based care Key elements of the original BEAM program include 1 expert-led educational videos using transdiagnostic therapy and emotion-focused parenting strategies 2 brief group sessions to consolidate therapeutic content and build social support 3 a community forum to enhance social connection and 4 symptom monitoring to track progress In case of a mental health or parenting-related crisis clinical coaches also consult via phone BEAM builds on evidence from the investigative teams knowledge synthesis work suggesting that mHealth therapeutics can address parent MI and while appealing to parents
The BEAM intervention has consistently demonstrated promising outcomes across various trials to date The investigative teams latest phase II RCT with mothers of toddlers found that the BEAM program outperformed a services-as-usual SAU control condition Significant improvements in parental MI symptoms including anxiety anger and alcohol use were observed Additionally BEAM was effective in reducing harsh parenting practices and negative parent-child interactions with substantial improvements observed for families living in poverty This trial also showed noteworthy participant engagement with retention rates 84 comparable to in-person therapy sessions This phase of research built on and replicated the success of earlier trials with both an open pilot and pilot RCT demonstrating BEAMs efficacy in reducing MI symptoms such as depression anxiety anger sleep issues and substance use Qualitative feedback from the initial trials emphasized the positive impact of the BEAM program on mental health and parenting leading to enhanced quality of life and improved family relationships Participants also highlighted the value of the social support gained through the online community
To further address family mental health needs this trial will test the readiness of the BEAM program for scalability The current study involves a hybrid effectiveness-implementation trial design to build on previous work The investigators will use both effectiveness and implementation metrics including short-term follow ups of primary outcomes alongside longer-term follow-ups of mental health and socio-developmental outcomes with linked administrative data This hybrid design follows the type 2 model in which effectiveness and implementation are co-primary aims and can be tracked simultaneously as the trial progresses This approach is consistent with the investigative teams rapid-cycle program development to date in which BEAM has been tested and adapted in response to patient and provider feedback through each iteration
This implementation trial aims to maximize BEAMs accessibility equitability and effectiveness for future nation-wide implementation For the current implementation trial the investigators conducted a full App rebuild to create BEAM Version 20 based on participant and Parent Advisory Board feedback BEAM 20 updates include improvements to psychoeducational video content eg high-quality video production animations closed captioning the mobile application user experience eg push notifications direct messaging integrated video player that adjusts video quality based on available bandwidth easy-to-navigate platform and functionality across mobile device operating systems iOS Android The weekly psychoeducational videos short symptom tracking surveys and social support community forum are now housed seamlessly within the BEAM app Other aspects of the program include individual check ins with trained peer coaches group drop-in sessions and a connection to a systems navigator whose role will be to support participants in accessing community resources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None