What side effects are associated with this type of intervention?

Common treatments for parenting that include mental health and parenting videos, peer coaching, social support forums, and supervised check-ins, such as those in the BEAM app, are generally considered safe and low-risk. However, potential side effects may include emotional distress when confronting personal parenting challenges, feelings of inadequacy or anxiety when comparing oneself to others in social support forums, and possible dependency on peer coaches for emotional support. Additionally, logistical challenges such as time management and consistent participation can be stressful for some parents.

What prior FDA approvals exist?

There are no specific FDA approvals for comprehensive parenting support programs like the BEAM app, which combines mental health and parenting videos, peer coaching, social support forums, and supervised check-ins. However, various individual components such as mental health treatments (e.g., antidepressants, anxiolytics) and therapeutic interventions (e.g., cognitive-behavioral therapy) are FDA-approved for related conditions like depression and anxiety, which can indirectly support parenting. Comprehensive digital health interventions like BEAM are emerging but typically do not fall under FDA regulation unless they involve specific medical treatments.

What other types of research exist?

Promising alternatives to the BEAM app for parenting patients in 2024 include: 1) ParentPal, which offers personalized parenting guidance, mental health resources, and community support; 2) MindfulParent, an app focusing on mindfulness-based stress reduction techniques for parents, combined with peer support and expert-led sessions; and 3) ThriveParenting, which integrates cognitive-behavioral therapy (CBT) principles with parenting strategies, peer coaching, and virtual support groups.

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Behavioral Intervention

BEAM App for Parent Mental Health (BEAM Trial)

N/A

Recruiting

Led By Leslie E Roos, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parent is 18 years of age or older

Be older than 18 years old

Must not have

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)

Parent is under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed 6 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an app called BEAM designed to help parents with young children manage depression, anxiety, and anger. The app offers videos, exercises, peer coaching, and social support. It aims to improve parent mental health and reduce parenting stress, which can benefit both the parents and their children. The BEAM program has shown promise in reducing depressive symptoms in adolescents with ADHD.

Who is the study for?

The BEAM trial is for parents over 18 living in Vancouver or Calgary with a child aged 3-4 years, who can understand English and are experiencing high levels of depression, anxiety, or anger. Parents with children having significant cognitive disorders or those with recent self-harm history cannot participate.

What is being tested?

This study tests the BEAM app, which offers videos on mental health and parenting, peer coaching, forums, and live sessions to support parents' mental health. The goal is to see how it affects parental stress, child behavior and development. Half of the participants will continue their usual treatments.

What are the potential side effects?

Since BEAM involves non-invasive methods like app-based learning and social support rather than medication or medical procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a parent and I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child has a condition like Down Syndrome or epilepsy, or cannot have an MRI due to metal implants.

Select...

I am a parent and I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in parental mental health

Secondary study objectives

Adverse childhood experiences

Changes in children's behaviour

Changes in children's mental health and development

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BEAM ProgramExperimental Treatment1 Intervention

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 II: Treatment-As-UsualActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Building Emotion Awareness and Mental Health (BEAM)

2021

N/A

~140

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for parenting, such as those in the BEAM app, include mental health and parenting videos, peer coaching, social support forums, and supervised check-ins. These components work together to address mental health issues like depression, anxiety, and anger by providing education, personalized support, community interaction, and professional guidance. This comprehensive approach helps parents manage their mental health and parenting challenges, reducing stress and improving outcomes for both parents and children.