Maternal DepressionBEAMNCT04772677
Building Emotional Awareness and Mental Health
A study testing BEAM Mental Health and Parenting Program in people with Maternal Depression, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression
- What is being tested?
- BEAM Mental Health and Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The University of Manitoba - Department of Psychology
Winnipeg, Manitoba, R3T 2N2
Leslie E. Roos, PhD, 2044747400, leslie.roos@umanitoba.ca
Marlee Salisbury, BSc, 5197011826, msalisb@myumanitoba.ca
About this study
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
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.
Read the 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:
- Support maternal mental wellness and parenting stress by creating an interactive psychoeducation \& social connection online platform.
- Evaluate the acceptability of the app and integrate parent feedback
- Determine the potential benefits of BEAM on maternal and child well-being.
- Conditions
- Maternal Depression
- Being tested
- BEAM Mental Health and Parenting Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEAM Mental Health and Parenting ProgramBehavioural
The BEAM program is a novel mobile app-based therapeutic intervention that incorporates key parenting concepts and Unified Protocol (UP) therapy modules with clinician-facilitated peer social support and connection. The primary aim of the program is to improve symptoms of depression and promote a positive parent-child relationship. There are three main components of the program: 1) the UP content, which will target maternal mental health symptomology, 2) the parenting skills training content, which is designed to correspond to the UP modules and promote maternal responsivity to children's emotions, and 3) a closed online community forum to encourage social support and connection between participants of the program.
| Study group | Role | What they receive |
|---|---|---|
| BEAM - Infant | Experimental | BEAM Infant will be delivered via mobile application to mothers with a 6-17 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials. Receives: Behavioral: BEAM Mental Health and Parenting Program |
| BEAM - Preschool | Experimental | BEAM Preschool will be delivered via mobile application to mothers with a 18-36 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting Videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials. Receives: Behavioral: BEAM Mental Health and Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Depression - Patient Health Questionnaire
Depression will be assessed with the Patient Health Questionnaire, a 9-item questionnaire will be used to measure depression presence and severity (mild to severe).
Measured: 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)
Change in Parenting Stress - Parent Daily Report
Parenting stress will be assessed with the Parent Daily Report, a scale which contains 12 items assessing the presence of difficult child behaviours and whether they were stressful for parents.
Measured: 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 (2)
Change in Family Relationship Quality
We will assess parent-child relationship quality and parenting strategies used by mothers through a collection of validated questionnaires (e.g., Parenting Stress Index, Parenting Scale), and the Couples Satisfaction Index will examine co-parent relationship quality in 2-parent households.
Measured: 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)
Change in Child and Family Function
A variety of questionnaires will support the collection of data pertaining to child and family function, including other maternal mental health symptoms and psychological functioning(e.g., emotion regulation, anxiety, anger, self-compassion) , child mental health and behaviour (e.g., Child Behaviour Checklist), and the family environment (e.g., child and parent screen-time). All questionnaires are standardized and well-validated
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start5 May 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Tactica Interactive, Centre for Healthcare Innovation, Research Manitoba
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772677
- Sponsor's protocol ID
- BEAM Pilot
- Acronym
- BEAM
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xie EB, Freeman M, Penner-Goeke L, Reynolds K, Lebel C, Giesbrecht GF, Rioux C, MacKinnon A, Sauer-Zavala S, Roos LE, Tomfohr-Madsen L. Building Emotional Awareness and Mental Health (BEAM): an open-pilot and feasibility study of a digital mental health and parenting intervention for mothers of infants. Pilot Feasibility Stud. 2023 Feb 18;9(1):27. doi: 10.1186/s40814-023-01245-x.
PubMed 36800982MacKinnon 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.
PubMed 35815022
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04772677
- Acronym / sponsor ID
- BEAM / BEAM Pilot
- Conditions
- Maternal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Calgary, Tactica Interactive, Centre for Healthcare Innovation, Research Manitoba
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Support maternal mental wellness and parenting stress by creating an interactive psychoeducation \& social connection online platform.
- Evaluate the acceptability of the app and integrate parent feedback
- Determine the potential benefits of BEAM on maternal and child well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BEAM - Infant | Experimental | Behavioral: BEAM Mental Health and Parenting ProgramBEAM Infant will be delivered via mobile application to mothers with a 6-17 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials. |
| BEAM - Preschool | Experimental | Behavioral: BEAM Mental Health and Parenting ProgramBEAM Preschool will be delivered via mobile application to mothers with a 18-36 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting Videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEAM Mental Health and Parenting ProgramThe BEAM program is a novel mobile app-based therapeutic intervention that incorporates key parenting concepts and Unified Protocol (UP) therapy modules with clinician-facilitated peer social support and connection. The primary aim of the program is to improve symptoms of depression and promote a positive parent-child relationship. There are three main components of the program: 1) the UP content, which will target maternal mental health symptomology, 2) the parenting skills training content, which is designed to correspond to the UP modules and promote maternal responsivity to children's emotions, and 3) a closed online community forum to encourage social support and connection between participants of the program. | Behavioural | BEAM - Infant, BEAM - Preschool |
Primary outcome
Change in Maternal Depression - Patient Health Questionnaire
Time frame: 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)
Depression will be assessed with the Patient Health Questionnaire, a 9-item questionnaire will be used to measure depression presence and severity (mild to severe).
Change in Parenting Stress - Parent Daily Report
Time frame: 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)
Parenting stress will be assessed with the Parent Daily Report, a scale which contains 12 items assessing the presence of difficult child behaviours and whether they were stressful for parents.
2 secondary outcomes
Change in Family Relationship Quality
Time frame: 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)
Change in Child and Family Function
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 36800982Xie EB, Freeman M, Penner-Goeke L, Reynolds K, Lebel C, Giesbrecht GF, Rioux C, MacKinnon A, Sauer-Zavala S, Roos LE, Tomfohr-Madsen L. Building Emotional Awareness and Mental Health (BEAM): an open-pilot and feasibility study of a digital mental health and parenting intervention for mothers of infants. Pilot Feasibility Stud. 2023 Feb 18;9(1):27. doi: 10.1186/s40814-023-01245-x.
- Derived from this study: PubMed 35815022MacKinnon 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEAM Mental Health and Parenting Program in people with Maternal Depression, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie E. Roos, PhD (204-474-7400, leslie.roos@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Depression - Patient Health Questionnaire (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.