Clinical trial NCT06046989: Building Emotional Awareness and Mental Health in Parenting (BEAM)
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent Mental Health
Parenting
Child Mental Health
Child Development
Keywords: anxiety
depression
anger
brain imaging
parenting
behavioural neuroscience
child development
child mental health
eHealth
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: Provincial Health Services Authority
name: Brain Canada
name: MindSea Development
name: Workerbee.tv
First posted: 2023-09-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. Examine the effects of the BEAM program on parent mental health (including symptoms of depression, anxiety, and anger).
2. Examine the effects of the BEAM program on children's behaviour and mental health.
3. Examine the effects of the BEAM program on children's brain structure and function.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Changes in parental mental health
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
Secondary outcomes:
measure: Changes in parenting stress
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in parent self-efficacy
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in discipline practices
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in relationship satisfaction
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in household environment
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in children's behaviour
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Changes in children's mental health and development
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Children's structural brain connectivity
timeFrame: To be assessed 6 months post-intervention
measure: Children's functional brain connectivity
timeFrame: To be assessed 6 months post-intervention
measure: Children's phonological processing
timeFrame: To be assessed 6 months post-intervention
measure: Children's speeded naming ability
timeFrame: To be assessed 6 months post-intervention
measure: Changes in parental sleep
timeFrame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention
measure: Adverse childhood experiences
timeFrame: To be assessed at pre-intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Catherine Lebel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacKinnon AL, Simpson KM, Salisbury MR, Bobula J, Penner-Goeke L, Berard L, Rioux C, Giesbrecht GF, Giuliano R, Lebel C, Protudjer JLP, Reynolds K, Sauer-Zavala S, Soderstrom M, Tomfohr-Madsen LM, Roos LE. Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers. Front Psychiatry. 2022 Jun 24;13:880972. doi: 10.3389/fpsyt.2022.880972. eCollection 2022.
citation: 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.