Clinical trial NCT05306626: Building Emotion Awareness and Mental Health (BEAM): Mothers of Toddlers
Official title: Building Emotion Awareness and Mental Health (BEAM): Randomized Controlled Trial for Mothers of Children 18-36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Mental health
Parenting
Maternal
Psychoeducation
E-health
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Tactica Interactive
name: Centre for Healthcare Innovation
name: Research Manitoba
First posted: 2022-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomized controlled trial will include two arms. For the experimental arm, 70 participants will be enrolled in the BEAM group. Participants randomized to the BEAM intervention group will receive the app-based and group telehealth BEAM program. The other 70 participants will be randomized to the control group and will receive treatment as usual. Randomization will be stratified based on which telehealth group timeslots participants identify being available for during eligibility screening.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depression symptoms
timeFrame: The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary outcomes:
measure: Change in parental assistance with child emotion regulation
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in partner social support
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in romantic relationship satisfaction
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in parenting stress
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in parenting discipline practices
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in parenting behaviours
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in anxiety symptoms
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in anger
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in self-compassion
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in sleep problems
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in suicidal ideation severity
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in self-esteem
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in alcohol use
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in cannabis use
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in child emotional and behavioural problems
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in child temperament
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other outcomes:
measure: Change in parent-child relationship quality
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in sensitive parenting
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in child emotional reactivity
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in heart rate
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in sleep duration
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in sleep quality
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Change in physical activity
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
measure: Feasibility of the BEAM program
timeFrame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Locations:
city: Winnipeg
country: Canada
facility: The University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.