NCT05306626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

February 17, 2022

Last Update Submit

April 12, 2023

Conditions

Depression, Anxiety

Keywords

Mental healthParentingMaternalPsychoeducationE-health

Outcome Measures

Primary Outcomes (1)

  • Change in depression symptoms

    Symptoms of depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a self-administered questionnaire with possible scores ranging from 0 to 27, where higher scores are indicative of more severe symptoms. A cut-off score of ≥ 10 will be used to identify participants who present with clinically concerning symptoms of depression.

    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 (16)

  • Change in parental assistance with child emotion regulation

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in partner social support

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in romantic relationship satisfaction

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in parenting stress

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in parenting discipline practices

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • +11 more secondary outcomes

Other Outcomes (8)

  • Change in parent-child relationship quality

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in sensitive parenting

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • Change in child emotional reactivity

    To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)

  • +5 more other outcomes

Study Arms (2)

The BEAM program group

EXPERIMENTAL

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.

Behavioral: Building Emotion Awareness and Mental Health (BEAM)

Treatment as usual group

NO INTERVENTION

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

Interventions

Building Emotion Awareness and Mental Health (BEAM)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.

The BEAM program group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details"People who identify as mothers"
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36064436DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Leslie E Roos, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

  • Lianne Tomfohr-Madsen, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

April 1, 2022

Study Start

December 1, 2021

Primary Completion

September 30, 2022

Study Completion

November 1, 2022

Last Updated

April 13, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

De-identified data (e.g. standardized questionnaire responses, aggregated program use data, sociodemographics linked to an identifier number) may be made available on public data platforms such as open science framework or a requirement by a granting agency or journal.

Shared Documents
STUDY PROTOCOL

Locations

CA(1)