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.

Overview

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.

Interventions

• Behavioral 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 co

Primary outcome measures

• Changes in parental mental health [Time frame: To be assessed pre-intervention, immediately post-intervention, and 6-months post-intervention]

Secondary outcome measures (12)

• 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

• University of Calgary — Calgary
• University of British Columbia — Vancouver

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/ PMID 35815022
• 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 PMID 36064436
• Tomfohr-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 chi PMID 42469885

Identifiers

NCT: NCT06046989 · REB23-0759

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗