Building Emotional Awareness and Mental Health in Parenting (BEAM)

NCT06046989 | Recruiting

• 1 other identifier: REB23-0759
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

Secondary Outcomes (13)

• Changes in parenting stress

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

• Changes in parent self-efficacy

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

• Changes in discipline practices

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

• Changes in relationship satisfaction

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

• Changes in household environment

  To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention

Study Arms (2)

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.

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.

Interventions

Building Emotion Awareness and Mental Health (BEAM) BEHAVIORAL

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.

BEAM Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital: collaborator
• Provincial Health Services Authority British Columbia: collaborator
• Brain Canada: collaborator
• MindSea Development: collaborator
• Workerbee.tv: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 35815022 BACKGROUND

• Xie EB, Simpson KM, Reynolds KA, Giuliano RJ, Protudjer JLP, Soderstrom M, Sauer-Zavala S, Giesbrecht GF, Lebel C, Mackinnon AL, Rioux C, Penner-Goeke L, Freeman M, Salisbury MR, Tomfohr-Madsen L, Roos LE. Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18-36 months. Trials. 2022 Sep 5;23(1):741. doi: 10.1186/s13063-022-06512-5.

  PMID: 36064436 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Lianne Tomfohr-Madsen, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Catherine Lebel, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Leslie E Roos, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianne Tomfohr-Madsen, PhD

CONTACT

604-822-6382; lianne.tomfohrmadsen@ubc.ca

Catherine Lebel, PhD

CONTACT

403-955-7241; clebel@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants who are conducting the MRI brain imaging will be blinded to the participants' condition (i.e., whether they are in the control or experimental group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)