Parent Mental HealthBEAMNCT06046989
Building Emotional Awareness and Mental Health in Parenting (BEAM)
A study testing Building Emotion Awareness and Mental Health (BEAM) in people with Parent Mental Health and Parenting, run by University of Calgary at 2 sites in Canada.
Trial summary
Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parent Mental Health, Parenting, Child Mental Health
- 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
- 240 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Mar 2024to Aug 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent is 18 years of age or older
- Must have a child who is 3-4 years old
- Must show clinically elevated symptoms of depression, anxiety, \&/or anger
- Living in the Vancouver or Calgary area
- Parent is comfortable understanding, speaking, and reading English
Who cannot join
- Parent is under the age of 18
- Does not show clinically elevated symptoms of depression, anxiety, and/or anger
- History of attempted suicide or self-harm in the past 6 months
- Does not live in the Vancouver or Calgary area
- Child has serious genetic, neurological, or neurodevelopmental disorders that impact cognitive function or brain structure/function (e.g., Down Syndrome, epilepsy, etc.), or if they have contra-indications to MRI scanning (i.e., metal implants)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Catherine Lebel, PhD, 403-955-7241, clebel@ucalgary.ca
Lianne Tomfohr-Madsen, PhD, 604-822-6382, lianne.tomfohrmadsen@ubc.ca
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
Lianne Tomfohr-Madsen, PhD, 604-833-6382, lianne.tomfohrmadsen@ubc.ca
Gerald Giesbrecht, PhD
About this study
Official title: BEAM: Building Emotional Awareness and Mental Health in Parenting. An App-based Intervention to Improve Parental Mental Health and Support Children's Brain Development.
Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. If left untreated, these disorders can be long-lasting and lead to child behaviour problems, brain changes, and risk for later mental illness. We developed an app-based treatment for parental mental illness: Building Emotional Awareness and Mental Health in Parenting (BEAM). The BEAM program includes mental health and parenting videos, peer coaching, as well as a forum and drop-in Zoom sessions where parents can connect with each other to receive and provide social support. The program is supported by peer coaches (parents with lived experience of recovery from mental illness and who may have received emotion-focused parenting support) and supervised by clinically-trained staff. Peer coaches check-in with parents weekly to support their progress. Our study will see the BEAM app's effect on parent mental health, parenting stress, child behaviour, and child brain structure and function. 240 parents with high depression, anxiety, and/or anger symptoms will be recruited, with half forming the treatment-as-usual group.
Read the detailed description
Although there are existing treatments for parental mental illness, there can be barriers to accessing care such as high cost and limited options in rural areas. This is troubling as untreated parental mental health symptoms can contribute to adverse consequences for both the parent and child. Thus, early intervention is critical to help prevent negative long-term effects. Digital resources can provide effective support, as they bypass many of the barriers associated with in-person interventions. The BEAM app was designed to combat these barriers and assist parents struggling with their mental health and the transition to parenthood. BEAM is a 12-week intervention with weekly videos about mental health and parenting for participants to watch. Exercises will be available so participants can practice new skills. Participants will also participate in weekly check-ins with peer coaches and have access to a secure forum where they can talk to other participants and receive social support. The BEAM Program also includes optional monthly drop-in sessions where parents can connect with each other in real time over Zoom.
Parent mental health (depression, anxiety, anger), parenting stress, and overreactive parenting will be assessed pre- and post-intervention, as well as 6 months post-intervention. Child behaviour and mental health will also be measured at all three timepoints (pre-, post-, and 6-months post-intervention). Child brain structure and function will be examined by MRI scans 6-months post-intervention. Participants will also receive brief wellness monitoring surveys in-app on a weekly basis.
There are three objectives for the present study:
- Examine the effects of the BEAM program on parent mental health (including symptoms of depression, anxiety, and anger).
- Examine the effects of the BEAM program on children's behaviour and mental health.
- Examine the effects of the BEAM program on children's brain structure and function.
- Being tested
- Building Emotion Awareness and Mental Health (BEAM)
- Keywords
- anxiety, depression, anger, brain imaging, parenting, behavioural neuroscience, child development, child mental health, eHealth
- Medical subject headings
- Anxiety Disorders, Depression
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
BEAM is based on best-practices in telehealth and science-based program design principles aimed at promoting parental mental health and supportive parenting. The BEAM Program mobile application is designed and managed by MindSea. The weekly one-on-one check-ins with peer coaches (parents who previously participated in another research group-based mental health intervention) will use the secure videoconferencing platform Zoom (Healthcare license) and direct messaging through the BEAM app. Peer coaches will also engage with participants on the community peer support forum. Monthly drop-in group peer support sessions will be facilitated by peer coaches and/or mental health professionals on the BEAM research team. The BEAM program's content emphasizes self-compassion, effective communication practices, and building social support networks.
| Study group | Role | What they receive |
|---|---|---|
| BEAM Program | Experimental | The BEAM Program is delivered via mobile application, weekly check-ins, and peer coaching. BEAM includes videos with emotion-regulation strategies that come from the Unified Protocol (evidence-based treatment for depression and anxiety disorders) and Dialectical Behavior Therapy (DBT) to help with mental health, as well they focus on developing self-compassion and effective communication. There are also supportive parenting videos which focus on providing parents with emotion-focused parenting strategies, based on Tuning in to Kids® and Parent Management Training - The Oregon Model (PMTO), which aim to help parents better understand and respond to their child. There will be approximately 15-20 minutes of videos to watch weekly. Receives: Behavioral: Building Emotion Awareness and Mental Health (BEAM) |
| Treatment-As-Usual | No intervention | This is the control arm of the study. It is designed to account for the potential effects of time on symptoms of depression, anxiety, and anger. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parental mental health
Parent mental health will be a composite of symptoms of depression, anxiety, and anger. Depression symptoms will be measured via the 10-item Center for Epidemiologic Studies Depression Scale (CES-D; scores range from 0-30 with higher score indicating more severe symptoms). Clinically elevated depressive symptoms will be identified with a cut-off of >10. Anxiety symptoms will be measured via the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form (raw scores range from 7-35 with higher scores indicating more severe symptoms). Parent anger will be measured via PROMIS Anger (raw scores range from 5-25 with higher scores indicating more anger). T-score cut-offs of >60 will be used to identify those with clinically elevated anger and anxiety symptoms. An aggregate variable for parent mental health symptoms will be computed by converting scores on the CES-D, PROMIS Anxiety, and PROMIS Anger to standardized z-scores and then taking their average.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Secondary outcomes (13)
Changes in parenting stress
The Parenting Stress Index (PSI) is a measure of parenting stress and interactional style. Scores range from 36-180; higher scores indicate greater parental stress.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in parent self-efficacy
The Me as a Parent Scale- Short Form (MaaPs-SF) is a 4-item measure that will be used to examine parenting self-efficacy. Scores can range from 4-20, with higher scores indicating greater self-efficacy.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in discipline practices
The Parenting Scale assesses the discipline practices of parents who have young children. The scores can range from 30-210; higher scores indicate more ineffective parenting discipline practices.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in relationship satisfaction
The Couple Satisfaction Index assesses relationship satisfaction. Scores can range from 0-21; higher scores indicate greater relationship satisfaction.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in household environment
The Chaos, Hubbub, and Order Scale will also be administered to capture the household environment. Scores can range from 0-15; higher scores indicate a more chaotic and disorganized environment.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in children's behaviour
A parent will complete the Behaviour Assessment System for Children Third Edition (BASC-3) Parent Rating Scales-Preschool which assesses children's social-emotional functioning and behaviour. This is a 139-item questionnaire which provides T scores and percentile ranks. T scores have a mean of 50 and a standard deviation of 10.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in children's mental health and development
This will be assessed using the Children's Somatic Symptoms Inventory-parent report (CSSI-8). The CSSI-8 scores can range from 0-32; higher scores indicate more somatic distress.
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Children's structural brain connectivity
Children's structural brain connectivity will be assessed via MRI scans. A variety of images will be collected including anatomical (T1-weighted, T2-weighted) and diffusion-weighted MRI scans. Total scan duration is approximately 45 minutes. During the MRI scan, participants may watch a movie or video of their choice. The study team will work with participants to maximize their comfort during the scan, but children may choose to decline further time in the MRI scanner at any time. Following the MRI scan, images will be preprocessed and analyzed to identify key anatomical regions and the structural (i.e., white matter) connectivity between regions. Preprocessing and analysis will be conducted using popular neuroimaging tools including FSL, FreeSurfer, MRtrix, and R.
Measured: To be assessed 6 months post-intervention
Children's functional brain connectivity
Children's functional brain connectivity will be assessed via MRI scans. A variety of images will be collected including anatomical (T1-weighted, T2-weighted), diffusion-weighted, and functional MRI scans. Total scan duration is approximately 45 minutes. During the MRI scan, participants may watch a movie or video of their choice. The study team will work with participants to maximize their comfort during the scan, but children may choose to decline further time in the MRI scanner at any time. Following the MRI scan, images will be preprocessed and analyzed to identify key anatomical regions and the functional (i.e., neuronal activity) connectivity between regions. Preprocessing and analysis will be conducted using popular neuroimaging tools including FSL, FreeSurfer, MRtrix, and R.
Measured: To be assessed 6 months post-intervention
Children's phonological processing
Children's language ability will be partly assessed using the Phonological Processing subtest of the NEPSY second edition (NEPSY-II). Phonological Processing is a 22-item measure with scores ranging from 0-22, with higher scores indicating better word segment recognition. The subtest also has percentile rank scores based on normative data.
Measured: To be assessed 6 months post-intervention
Children's speeded naming ability
Children's language ability will be partly assessed using the Speeded Naming subtest of the NEPSY-II. Speeded Naming is a 2-item measure with a maximum completion time of 300 seconds for naming 12 colours and 300 seconds for naming 12 shapes. A shorter completion time means more rapid access to and vocalization of names and shapes. The subtest also has percentile rank scores based on normative data.
Measured: To be assessed 6 months post-intervention
Changes in parental sleep
The PROMIS Sleep Disturbance- Short Form (PROMIS Sleep) will be used to assess parents' sleep. It is an 8-item measure with raw scores ranging from 8 to 40, where higher scores indicate greater sleep disturbance. Raw scores will be converted to T-scores which can be used to categorize sleep disturbance as "None to Slight," "Mild," "Moderate," or "Severe."
Measured: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Adverse childhood experiences
The Adverse Childhood Experiences (ACEs) questionnaire will be administered to parents to examine what, if any, adverse experiences they had before the age of 18. It is an 11-item questionnaire that examines eight areas of adversity across three factors: Household Dysfunction (score range: 0-5), Physical/Emotional Abuse (score range: 3-9), Sexual Abuse (score range: 3-9).
Measured: To be assessed at pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Mar 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parent Mental HealthStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 study will include two arms and is a randomized controlled trial. For the experimental arm, a total of 120 participants will be enrolled in the BEAM group in cohorts of 24. The other 120 participants will be in the treatment-as-usual group where they will not have access to BEAM but will be able to access other resources or treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, Provincial Health Services Authority British Columbia, Brain Canada, MindSea Development, Workerbee.tv
- Responsible party
- Principal investigator, Lianne Tomfohr-Madsen, University of British Columbia
- Investigators
- Lianne Tomfohr-Madsen, PhD, Principal investigator, University of British ColumbiaCatherine Lebel, PhD, Principal investigator, University of CalgaryLeslie E Roos, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046989
- Sponsor's protocol ID
- REB23-0759
- Acronym
- BEAM
- Status last verified
- Mar 2024
- First submitted
- 30 Aug 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35815022Xie 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 36064436Tomfohr-Madsen LM, Roos LE, Martinez AM, Muslu H, Gill H, Cameron EE, Freeman M, Dewsnap K, Giesbrecht GF, Oberlander TF, Leijser L, MacMaster F, Geeraert B, McNeil D, Lebel C. Building Emotional Awareness and Mental Health in Parenting (BEAM): protocol for a parallel-group randomized controlled non-inferiority trial for an app based intervention to improve postpartum mental health and support children's brain development in Western Canada. Trials. 2026 Jul 17. doi: 10.1186/s13063-026-09849-3. Online ahead of print.
PubMed 42469885
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEAM: Building Emotional Awareness and Mental Health in Parenting. An App-based Intervention to Improve Parental Mental Health and Support Children's Brain Development.
- ClinicalTrials.gov ID
- NCT06046989
- Acronym / sponsor ID
- BEAM / REB23-0759
- Keywords
- anxiety, depression, anger, brain imaging, parenting, behavioural neuroscience, child development, child mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, Provincial Health Services Authority British Columbia, Brain Canada, MindSea Development, Workerbee.tv
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. If left untreated, these disorders can be long-lasting and lead to child behaviour problems, brain changes, and risk for later mental illness. We developed an app-based treatment for parental mental illness: Building Emotional Awareness and Mental Health in Parenting (BEAM). The BEAM program includes mental health and parenting videos, peer coaching, as well as a forum and drop-in Zoom sessions where parents can connect with each other to receive and provide social support. The program is supported by peer coaches (parents with lived experience of recovery from mental illness and who may have received emotion-focused parenting support) and supervised by clinically-trained staff. Peer coaches check-in with parents weekly to support their progress. Our study will see the BEAM app's effect on parent mental health, parenting stress, child behaviour, and child brain structure and function. 240 parents with high depression, anxiety, and/or anger symptoms will be recruited, with half forming the treatment-as-usual group.
Detailed description
Although there are existing treatments for parental mental illness, there can be barriers to accessing care such as high cost and limited options in rural areas. This is troubling as untreated parental mental health symptoms can contribute to adverse consequences for both the parent and child. Thus, early intervention is critical to help prevent negative long-term effects. Digital resources can provide effective support, as they bypass many of the barriers associated with in-person interventions. The BEAM app was designed to combat these barriers and assist parents struggling with their mental health and the transition to parenthood. BEAM is a 12-week intervention with weekly videos about mental health and parenting for participants to watch. Exercises will be available so participants can practice new skills. Participants will also participate in weekly check-ins with peer coaches and have access to a secure forum where they can talk to other participants and receive social support. The BEAM Program also includes optional monthly drop-in sessions where parents can connect with each other in real time over Zoom.
Parent mental health (depression, anxiety, anger), parenting stress, and overreactive parenting will be assessed pre- and post-intervention, as well as 6 months post-intervention. Child behaviour and mental health will also be measured at all three timepoints (pre-, post-, and 6-months post-intervention). Child brain structure and function will be examined by MRI scans 6-months post-intervention. Participants will also receive brief wellness monitoring surveys in-app on a weekly basis.
There are three objectives for the present study:
- Examine the effects of the BEAM program on parent mental health (including symptoms of depression, anxiety, and anger).
- Examine the effects of the BEAM program on children's behaviour and mental health.
- Examine the effects of the BEAM program on children's brain structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will include two arms and is a randomized controlled trial. For the experimental arm, a total of 120 participants will be enrolled in the BEAM group in cohorts of 24. The other 120 participants will be in the treatment-as-usual group where they will not have access to BEAM but will be able to access other resources or treatment.
| Arm | Type | Receives |
|---|---|---|
| BEAM Program | Experimental | Behavioral: Building Emotion Awareness and Mental Health (BEAM)The BEAM Program is delivered via mobile application, weekly check-ins, and peer coaching. BEAM includes videos with emotion-regulation strategies that come from the Unified Protocol (evidence-based treatment for depression and anxiety disorders) and Dialectical Behavior Therapy (DBT) to help with mental health, as well they focus on developing self-compassion and effective communication. There are also supportive parenting videos which focus on providing parents with emotion-focused parenting strategies, based on Tuning in to Kids® and Parent Management Training - The Oregon Model (PMTO), which aim to help parents better understand and respond to their child. There will be approximately 15-20 minutes of videos to watch weekly. |
| Treatment-As-Usual | No intervention | –This is the control arm of the study. It is designed to account for the potential effects of time on symptoms of depression, anxiety, and anger. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parent is 18 years of age or older
- Must have a child who is 3-4 years old
- Must show clinically elevated symptoms of depression, anxiety, \&/or anger
- Living in the Vancouver or Calgary area
- Parent is comfortable understanding, speaking, and reading English
Key exclusion criteria (5 listed)
- Parent is under the age of 18
- Does not show clinically elevated symptoms of depression, anxiety, and/or anger
- History of attempted suicide or self-harm in the past 6 months
- Does not live in the Vancouver or Calgary area
- Child has serious genetic, neurological, or neurodevelopmental disorders that impact cognitive function or brain structure/function (e.g., Down Syndrome, epilepsy, etc.), or if they have contra-indications to MRI scanning (i.e., metal implants)
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)BEAM is based on best-practices in telehealth and science-based program design principles aimed at promoting parental mental health and supportive parenting. The BEAM Program mobile application is designed and managed by MindSea. The weekly one-on-one check-ins with peer coaches (parents who previously participated in another research group-based mental health intervention) will use the secure videoconferencing platform Zoom (Healthcare license) and direct messaging through the BEAM app. Peer coaches will also engage with participants on the community peer support forum. Monthly drop-in group peer support sessions will be facilitated by peer coaches and/or mental health professionals on the BEAM research team. The BEAM program's content emphasizes self-compassion, effective communication practices, and building social support networks. | Behavioural | BEAM Program |
Primary outcome
Changes in parental mental health
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Parent mental health will be a composite of symptoms of depression, anxiety, and anger. Depression symptoms will be measured via the 10-item Center for Epidemiologic Studies Depression Scale (CES-D; scores range from 0-30 with higher score indicating more severe symptoms). Clinically elevated depressive symptoms will be identified with a cut-off of >10. Anxiety symptoms will be measured via the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form (raw scores range from 7-35 with higher scores indicating more severe symptoms). Parent anger will be measured via PROMIS Anger (raw scores range from 5-25 with higher scores indicating more anger). T-score cut-offs of >60 will be used to identify those with clinically elevated anger and anxiety symptoms. An aggregate variable for parent mental health symptoms will be computed by converting scores on the CES-D, PROMIS Anxiety, and PROMIS Anger to standardized z-scores and then taking their average.
13 secondary outcomes
Changes in parenting stress
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in parent self-efficacy
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in discipline practices
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in relationship satisfaction
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in household environment
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in children's behaviour
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Changes in children's mental health and development
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Children's structural brain connectivity
Time frame: To be assessed 6 months post-intervention
Children's functional brain connectivity
Time frame: To be assessed 6 months post-intervention
Children's phonological processing
Time frame: To be assessed 6 months post-intervention
Children's speeded naming ability
Time frame: To be assessed 6 months post-intervention
Changes in parental sleep
Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Adverse childhood experiences
Time frame: To be assessed at pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: 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.
- Background: 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.
- Derived from this study: PubMed 42469885Tomfohr-Madsen LM, Roos LE, Martinez AM, Muslu H, Gill H, Cameron EE, Freeman M, Dewsnap K, Giesbrecht GF, Oberlander TF, Leijser L, MacMaster F, Geeraert B, McNeil D, Lebel C. Building Emotional Awareness and Mental Health in Parenting (BEAM): protocol for a parallel-group randomized controlled non-inferiority trial for an app based intervention to improve postpartum mental health and support children's brain development in Western Canada. Trials. 2026 Jul 17. doi: 10.1186/s13063-026-09849-3. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Lianne Tomfohr-Madsen, PhD principal investigator
University of British Columbia
Catherine Lebel, PhD principal investigator
University of Calgary
Leslie E Roos, PhD principal investigator
University of Manitoba
2 sites 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 Parent Mental Health and Parenting, run by University of Calgary at 2 sites 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 5 inclusion and 5 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lianne Tomfohr-Madsen, PhD (604-822-6382, lianne.tomfohrmadsen@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parental mental health (time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention). 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 NCT06046989, which also lists 3 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 27 Mar 2024.