Building Emotion Awareness and Mental Health (BEAM): Mothers of Toddlers

NCT ID: NCT05306626

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-11-01

Brief Summary

During the COVID-19 pandemic, the prevalence of maternal depression and anxiety has increased and research suggests that the cognitive development of children born during the pandemic has been impacted. There are significant concerns that a cohort of children may be at-risk for mental illness and impaired self-regulation due to elevated exposure to perinatal maternal mental illness. Intervention is crucial as the intergenerational effects of maternal mental illness are most pronounced when mental health concerns persist. There is currently an urgent need for accessible eHealth interventions for mothers of young children as the pandemic has contributed to an increased prevalence of mental health concerns and to additional barriers to services. The Building Emotion Awareness and Mental Health (BEAM) app-based program was developed to help address maternal mental health concerns and parenting stress. A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to treatment as usual (TAU) among a sample of 140 mothers who self-report moderate-to-severe symptoms of depression and/or anxiety and have a child 18 to 36 months-old.

Detailed Description

Maternal mental health symptoms in the first few years following childbirth are common and can have contributed to adverse consequences for both mother and baby. Two of the most common perinatal mental health concerns are depression and anxiety. The COVID-19 pandemic has introduced heightened stressors for families, including physical isolation from support and social networks, additional childcare responsibilities, and economic uncertainty. Unsurprisingly, the pandemic has also led to an increased prevalence of maternal depression and anxiety in Canada and around the world. These mental health problems are associated with increased health problems and low quality of life for mothers. The COVID-19 pandemic has also posed additional challenges to families and mothers with young children are experiencing heightened parenting stress, increasing their support needs. For mothers with depression, these additional parenting stressors can worsen the symptoms and severity their depression. Furthermore, emerging research suggests that the COVID-19 pandemic has had detrimental effects on early child cognitive development.

According to the developmental origins of health and disease, exposure to maternal depression in the first 5 years of life is linked to children's mental illness, cognitive impairments, and developmental delays. Intervening early is important to help prevent negative long-term consequences for mothers and their children. Without treatment, maternal depressive symptoms tend to remain consistent throughout the preschool years and the adverse consequences of maternal mental health concerns are most pronounced when depression persists. Although there are evidence-based treatments to address maternal mental illness, accessing care can be challenging due to the exceedingly high barriers to service due to COVID-19, such as lack of childcare and time.

Web-based resources have been identified as a preference for mental health support by mothers with mental health problems during the perinatal period. Furthermore, mothers have expressed appreciation for peer support during the perinatal period as social support is often highly relied upon in the postnatal period to care for their infants and themselves. Support from other mothers, specifically, has been found to be helpful in recovering from postpartum depression and individuals report higher satisfaction in treatments of postpartum depression that include a peer support component.

E-health interventions, designed to target both maternal mental illness and parenting abilities, and that prioritize social support, may be a promising avenue to address the intergenerational impact of perinatal mental health problems. The Building Emotion Awareness and Mental Health (BEAM) program is an app-based and online group therapy program that was developed to respond to the high needs of mothers managing depression, anxiety, and parenting stress.

There are 3 objectives for this study:

Evaluate the efficacy of the BEAM app-based program for improving depression compared to a treatment as usual (TAU) control group.

Examine the benefits of BEAM for family relationships, anxiety, parenting stress and behaviours, and child functioning.

Examine exploratory outcomes of parent-child relationship quality, maternal sensitivity, and child emotional reactivity.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The BEAM program group

The BEAM Program is delivered via mobile application and weekly group telehealth sessions. BEAM includes approximately 20 minutes of weekly asynchronous video modules on parenting and mental health. Mental Health videos will provide information and emotion-regulation strategies that draw from the Unified Protocol, an evidence-based treatment for depression and anxiety disorders. Self-compassion and effective communication will also be central focuses of the mental health content. Supportive parenting videos will provide parents with emotion-focused parenting strategies and help parents understand and respond to their children's challenging emotions and behaviours. The weekly group telehealth sessions will allow participants to discuss content and ask questions, with the purpose of increasing a sense of community and social support. The online community forum will provide a space for participants to reflect on their learned skills and connect with other participants in the program.

Group Type: EXPERIMENTAL

Building Emotion Awareness and Mental Health (BEAM)

Intervention Type: BEHAVIORAL

The BEAM Program is based on best-practices in telehealth and science-based program design principles aimed at promoting maternal mental health and supportive parenting. The BEAM Program mobile application is designed and managed by Tactica Interactive and hosted on the University of Manitoba secure servers. The weekly group telehealth sessions will be led by clinical coaches (a mental health professional or trainee) and will use the secure videoconferencing platform Zoom (Healthcare license). Parent coaches will be mothers who have recently participated in another research group-based mental health intervention. Parent coaches will engage with participants on the community peer support forum and attend weekly telehealth sessions. The therapeutic aims of the BEAM program are to improve anxiety and depression symptoms and parenting skills using content that draws from the Unified Protocol, and emphasizes self-compassion, effective communication practices, and social support networks.

Treatment as usual group

The treatment as usual (TAU) control arm of the study is designed to account for the potential effects of time on depression symptoms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Building Emotion Awareness and Mental Health (BEAM)

The BEAM Program is based on best-practices in telehealth and science-based program design principles aimed at promoting maternal mental health and supportive parenting. The BEAM Program mobile application is designed and managed by Tactica Interactive and hosted on the University of Manitoba secure servers. The weekly group telehealth sessions will be led by clinical coaches (a mental health professional or trainee) and will use the secure videoconferencing platform Zoom (Healthcare license). Parent coaches will be mothers who have recently participated in another research group-based mental health intervention. Parent coaches will engage with participants on the community peer support forum and attend weekly telehealth sessions. The therapeutic aims of the BEAM program are to improve anxiety and depression symptoms and parenting skills using content that draws from the Unified Protocol, and emphasizes self-compassion, effective communication practices, and social support networks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A mother with a child aged 18-36 months old
• Moderate-to-severe symptoms of depression and/or anxiety (i.e., a score at or above 10 on the Patient Health Questionnaire and/or the General Anxiety Disorder scale
• Comfortable understanding, speaking, and reading English
• Live in Manitoba or Alberta, Canada
• Be available to attend weekly telehealth sessions
• Consent to wearing a Fitbit
• Complete baseline screener and questionnaire and be willing to meet the research team through Zoom (either during assessment or technology check in session).

Exclusion Criteria

• Child is outside of the 18-36 month age range
• Does not meet criteria for moderate-to-severe depression and/or anxiety
• Lives outside of Manitoba or Alberta
• A reported history of attempted suicide in the past year or self-harm in the past 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

Tactica Interactive

UNKNOWN

Sponsor Role: collaborator

Centre for Healthcare Innovation

UNKNOWN

Sponsor Role: collaborator

Research Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie E Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Lianne Tomfohr-Madsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36064436 (View on PubMed)

Other Identifiers

BEAM toddler RCT

Identifier Type: -

Identifier Source: org_study_id