Depression, AnxietyNCT05306626
Building Emotion Awareness and Mental Health (BEAM): Mothers of Toddlers
A study testing Building Emotion Awareness and Mental Health (BEAM) in people with Depression, Anxiety, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Building Emotion Awareness and Mental Health (BEAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to 1 Nov 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of Manitoba - Department of Psychology
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Building Emotion Awareness and Mental Health (BEAM): Randomized Controlled Trial for Mothers of Children 18-36 Months
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.
Read the 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
- Being tested
- Building Emotion Awareness and Mental Health (BEAM)
- Keywords
- Mental health, Parenting, Maternal, Psychoeducation, E-health
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Emotion Awareness and Mental Health (BEAM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Parental assistance with child emotion regulation will be measured using the Parental Assistance with Child Emotion Regulation scale (PACER). The PACER is a parent-report measure of how parents assist children with regulation of emotion using specific strategies. Scores range from 50-350, where higher scores indicate higher engagement in behaviours that support child emotion regulation.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in partner social support
Partner social support will be measured using the Social Support Effectiveness Questionnaire (SSE). The SSE is a self-report measure of partner social support effectiveness .Total scores can range from 0 to 80, with higher scores indicating more effective support.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in romantic relationship satisfaction
Romantic relationship satisfaction will be measured using the 4-item Couple Satisfaction Index (CSI-4). The CSI is a self-report measure of the individual's global evaluations of their romantic relationship. Scores range from 0 to 21, with higher scores reflecting higher levels of satisfaction.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting stress
Parenting stress will be measured using the Parenting Stress Index (PSI), a self-report measure of parenting stress and interactional style across 3 subscales (parent distress, parent-child dysfunction, difficult child) which combine to form a Total Stress scale. Raw scores range from 36 to 180, with higher scores indicating higher levels of parent stress.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting discipline practices
Parenting behaviour and dysfunctional discipline will be measured using the Parenting Scale (PS), a self-rating scale to measure discipline practices in parents of young children. Scores range from 30-210, with higher scores indicating more ineffective parenting discipline practices.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting behaviours
Parenting behaviours will be measured using the Parenting Young Children (PARYC) measure, a self-report of parenting strategies/behaviours relevant for caregivers of young children. Scores range from 21-105, with higher scores indicating more proactive parenting behaviours.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in anxiety symptoms
Maternal anxiety will be measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale, a self-rating scale to measure anxiety. Scores range from 0-21, with higher scores indicating higher levels of anxiety.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in anger
Anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1-Anger 5a, a self-report measure to assess the severity and frequency of an individual's anger. Scores range from 5-25, where higher scores indicate more anger.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in self-compassion
Self-compassion will be measured using the Self-Compassion Scale Short-Form (SCS-SF), a self-report measure of self-compassion. Scores range from 12-60, with higher scores indicating higher levels of self-compassion.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in sleep problems
Sleep disturbance will be measured using the PROMIS Sleep Disturbance Scale, a self-report of perceptions of sleep quality, depth, and restoration with the past seven days. Scores range from 8-40, with higher scores indicating greater severity of sleep disturbance.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in suicidal ideation severity
Suicidal ideation severity will be measured using the Depression Symptom Index Suicidality Subscale (DSI-SS), a self-report measure of suicidal ideation. Scores range from 0 to 12, where higher scores indicate higher suicidal ideation.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in self-esteem
Self-esteem will be measured using the Single Item Self-Esteem Scale (SISE), a one-item self-report measure of global self-esteem. Scores range from 1 to 7, where higher scores indicate higher self-esteem.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in alcohol use
Alcohol use will be measured using the Alcohol Use Disorder Identification Test (AUDIT), a self-report measure of alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0 to 40, where higher scores indicate more hazardous alcohol use.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in cannabis use
Cannabis use will be measured using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R), a self-report of cannabis misuse. Scores range from 0 to 32, where higher scores indicate more hazardous cannabis use and scores of 12 or more indicating a possible Cannabis Use Disorder.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in child emotional and behavioural problems
Child emotional and behavioural problems will be measured using the Preschool Pediatric Symptom Checklist (PPSC), a parent report measure of early emotional and behavioural problems in infants and pre-schoolers. Scores range from 0 to 34, where higher scores indicate higher incidence of emotional and behavioural problems
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in child temperament
Child temperament will be measured using a subset of questions from the Early Child Behavior Questionnaire (ECBQ), a parent report measure of temperament in children aged 1 to 3. Scores range from 1 to 7, where higher scores indicate higher levels of the temperamental trait.
Measured: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Dec 2021
- Primary completion30 Sep 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
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
- Investigators
- Leslie E Roos, PhD, Principal investigator, University of ManitobaLianne Tomfohr-Madsen, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306626
- Sponsor's protocol ID
- BEAM toddler RCT
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36064436
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Emotion Awareness and Mental Health (BEAM): Randomized Controlled Trial for Mothers of Children 18-36 Months
- ClinicalTrials.gov ID
- NCT05306626
- Acronym / sponsor ID
- BEAM toddler RCT
- Conditions
- Depression, Anxiety
- Keywords
- Mental health, Parenting, Maternal, Psychoeducation, E-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Calgary, Tactica Interactive, Centre for Healthcare Innovation, Research Manitoba
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 1 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The BEAM program group | Experimental | Behavioral: Building Emotion Awareness and Mental Health (BEAM)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | The BEAM program group |
Primary outcome
Change in depression symptoms
Time frame: The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
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.
16 secondary outcomes
Change in parental assistance with child emotion regulation
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in partner social support
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in romantic relationship satisfaction
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting stress
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting discipline practices
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in parenting behaviours
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in anxiety symptoms
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in anger
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in self-compassion
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in sleep problems
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in suicidal ideation severity
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in self-esteem
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in alcohol use
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in cannabis use
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in child emotional and behavioural problems
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Change in child temperament
Time frame: To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 36064436Xie 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Leslie E Roos, PhD principal investigator
University of Manitoba
Lianne Tomfohr-Madsen, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Emotion Awareness and Mental Health (BEAM) in people with Depression, Anxiety, 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 7 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: finished, as of the sponsor's last update on 13 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms (time frame: The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)). 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 NCT05306626, which also lists 1 linked publication.
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 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.