Building Emotional Awareness and Mental Health in Parenting (BEAM)

NCT ID: NCT06046989

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2026-08-31

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.

Conditions

Parent Mental Health; Parenting; Child Mental Health; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BEAM Program

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.

Group Type: EXPERIMENTAL

Building Emotion Awareness and Mental Health (BEAM)

Intervention Type: 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.

Treatment-As-Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Children's Hospital

OTHER

Sponsor Role: collaborator

Provincial Health Services Authority

OTHER

Sponsor Role: collaborator

Brain Canada

OTHER

Sponsor Role: collaborator

MindSea Development

UNKNOWN

Sponsor Role: collaborator

Workerbee.tv

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Lianne Tomfohr-Madsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lianne Tomfohr-Madsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Catherine Lebel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Leslie E Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Lianne Tomfohr-Madsen, PhD

Role: CONTACT

lianne.tomfohrmadsen@ubc.ca

604-822-6382

Catherine Lebel, PhD

Role: CONTACT

clebel@ucalgary.ca

403-955-7241

Facility Contacts

Catherine Lebel, PhD

Role: primary

clebel@ucalgary.ca

403-955-7241

Lianne Tomfohr-Madsen, PhD

Role: backup

lianne.tomfohrmadsen@ubc.ca

604-822-6382

Lianne Tomfohr-Madsen, PhD

Role: primary

lianne.tomfohrmadsen@ubc.ca

604-833-6382

References

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.

Reference Type: BACKGROUND

PMID: 35815022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36064436 (View on PubMed)

Other Identifiers

REB23-0759

Identifier Type: -

Identifier Source: org_study_id