Clinical trial NCT04772677: Building Emotional Awareness and Mental Health
Official title: Building Emotional Awareness and Mental Health - A Mobile App-Based Parenting Program for Depressed Mothers of Infants and Preschoolers, Matched With Unified Protocol Therapy Skills
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Depression
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: 2021-02-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study will include two arms. The first arm will enroll 30 mothers with children aged 6-17 months (i.e., infant cohort). The second arm will enroll 30 mothers with children aged 18-36 months (i.e., preschool cohort). The postpartum cohort will receive access to the online psychoeducation and social-connection platform and the preschool cohort will be randomized to the program or a services as usual control group. Analyses will be performed separately per each arm.
Primary purpose: TREATMENT

Brief summary: Since its emergence in December 2019, COVID-19 has reshaped the world. Mental health problems are predicted to rise dramatically as a secondary effect of the disease and measures put in place to contain it. Our emerging evidence shows parents of young children have not been spared from these effects and are experiencing 4-fold increases depression and anxiety. Young children are highly vulnerable to parent mental illness due to their reliance on caregivers to meet basic needs. Interventions are needed that consider the unique mental health and parenting challenges families are encountering during the pandemic. Our team of mental health and program development experts will address these needs through an online psychoeducation and social-connection platform, BEAM: Building Emotional Awareness and Mental Health. BEAM brings together best practices in online telehealth programs in a highly personalized and interactive format to address multiple family needs. With clinical research investigators across provinces, the BEAM pilot project will provide services to 60 mothers (30 per group) of 6-36 month old children in Manitoba and Alberta.

Detailed description: Families are facing unprecedented challenges during the COVID-19 pandemic. Emerging evidence from our recent family research shows elevated rates of maternal depression in parents of 0-5-year-old children, compared to pre-pandemic cohorts with similar demographic profiles. In our combined data of over 3000 families of 0 to 5-year-old children, 37-48% of mothers were classified as depressed, based on child age group, with 65% of depressed mothers also experiencing anxiety. In early childhood, exposure to maternal mental illness predicts risk for children's own mental health problems, developmental delays, asthma, and injury risk. For mothers themselves, depression contributes to health problems and low quality of life. Notably, these harms are most pronounced when depression persists, highlighting the importance of intervening early to prevent intergenerational health impairments.

Although evidence-based treatments exist to address maternal mental illness, there are high barriers to accessing care due to COVID-19. These include physical distancing, high costs of individual therapy, closure of existing services, and overwhelming childcare demands. Only 5% of mothers in our sample with depression report accessing services in the past month. The parenting stress associated with maternal depression is established to lead to low-quality interactions and harsh discipline, which is particularly concerning with children are spending nearly all their time at home.

Addressing these intergenerational health concerns will require innovative program design methods to simultaneously treat maternal mental illness and address parenting risks. We have developed the Building Emotional Awareness \& Mental Health (BEAM) program to immediately address these needs. Investing in maternal mental health now, before problems are entrenched, is expected to yield high health and economic benefits by preventing the long-term consequences of maternal depression from becoming embedded in children's biological and behavioural development. Our team of mental health, parenting, and program development experts will address these needs through an online psycho-education and social-connection platform.

There are 3 objectives for this study:

1. Support maternal mental wellness and parenting stress by creating an interactive psychoeducation \& social connection online platform.
2. Evaluate the acceptability of the app and integrate parent feedback
3. Determine the potential benefits of BEAM on maternal and child well-being.

Eligibility criteria: Inclusion Criteria:

* Must have a 6-36 months old child
* Must have moderate-severe depression (i.e., a score of 10+ on the Patient Health Questionnaire)
* 18+ years of age
* comfortable understanding, speaking, and reading English
* Living in Manitoba or Alberta
* Must be available for weekly Zoom sessions

Exclusion Criteria:

* Child is outside the 6-36 month age range
* Lives outside of Manitoba or Alberta
* Does not meet criteria for moderate-severe depression
* A history of attempted suicide in past year or self-harm in past 6 months), or significant suicidal ideation.

Primary outcomes:
measure: Change in Maternal Depression - Patient Health Questionnaire
timeFrame: PHQ-9 to be completed during eligibility screening, at T1 before starting the BEAM program, weekly for 10 weeks, at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)
measure: Change in Parenting Stress - Parent Daily Report
timeFrame: PDR to be completed at T1 before starting the BEAM Program, weekly for 10 weeks, at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)
Secondary outcomes:
measure: Change in Family Relationship Quality
timeFrame: To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)
measure: Change in Child and Family Function
timeFrame: To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)
Other outcomes:
measure: Change in Substance Use
timeFrame: To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)
Locations:
city: Winnipeg
country: Canada
facility: The University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
References:
citation: 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.