Building Emotional Awareness and Mental Health

NCT04772677 | Unknown

• 1 other identifier: BEAM Pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Since its emergence in December 2019, COVID-19 has reshaped the world. Mental health problems are predicted to rise dramatically as a secondary effect of the disease and measures put in place to contain it. Our emerging evidence shows parents of young children have not been spared from these effects and are experiencing 4-fold increases depression and anxiety. Young children are highly vulnerable to parent mental illness due to their reliance on caregivers to meet basic needs. Interventions are needed that consider the unique mental health and parenting challenges families are encountering during the pandemic. Our team of mental health and program development experts will address these needs through an online psychoeducation and social-connection platform, BEAM: Building Emotional Awareness and Mental Health. BEAM brings together best practices in online telehealth programs in a highly personalized and interactive format to address multiple family needs. With clinical research investigators across provinces, the BEAM pilot project will provide services to 60 mothers (30 per group) of 6-36 month old children in Manitoba and Alberta.

Conditions

Maternal Depression

Outcome Measures

Primary Outcomes (2)

• Change in Maternal Depression - Patient Health Questionnaire

  Depression will be assessed with the Patient Health Questionnaire, a 9-item questionnaire will be used to measure depression presence and severity (mild to severe).

  PHQ-9 to be completed during eligibility screening, at T1 before starting the BEAM program, weekly for 10 weeks, at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)

• Change in Parenting Stress - Parent Daily Report

  Parenting stress will be assessed with the Parent Daily Report, a scale which contains 12 items assessing the presence of difficult child behaviours and whether they were stressful for parents.

  PDR to be completed at T1 before starting the BEAM Program, weekly for 10 weeks, at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)

Secondary Outcomes (2)

• Change in Family Relationship Quality

  To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)

• Change in Child and Family Function

  To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)

Other Outcomes (1)

• Change in Substance Use

  To be assessed before starting the BEAM Program (T1), at the end of the program (T2; 10 weeks), and at follow-up (T3; 18 weeks)

Study Arms (2)

BEAM - Infant

EXPERIMENTAL

BEAM Infant will be delivered via mobile application to mothers with a 6-17 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials.

Behavioral: BEAM Mental Health and Parenting Program

BEAM - Preschool

EXPERIMENTAL

BEAM Preschool will be delivered via mobile application to mothers with a 18-36 month old child. It will include 15-30-minute lessons on mental health and parenting and a closed community forum. Mental Health videos will provide information and tools via The Unified Protocol, a best-practice program to address dysregulated emotions across mood and anxiety disorders. Parenting Videos will help parents understand their children's challenging behaviours and teach proactive approaches to prevent negative interactions and promote a positive relationship. A closed online community forum will be facilitated by a mental health clinician and parent coach. Weekly Zoom meetings will be facilitated by clinicians where participants can meet with other participants, ask questions about the program content, or discuss the week's materials.

Behavioral: BEAM Mental Health and Parenting Program

Interventions

BEAM Mental Health and Parenting Program BEHAVIORAL

The BEAM program is a novel mobile app-based therapeutic intervention that incorporates key parenting concepts and Unified Protocol (UP) therapy modules with clinician-facilitated peer social support and connection. The primary aim of the program is to improve symptoms of depression and promote a positive parent-child relationship. There are three main components of the program: 1) the UP content, which will target maternal mental health symptomology, 2) the parenting skills training content, which is designed to correspond to the UP modules and promote maternal responsivity to children's emotions, and 3) a closed online community forum to encourage social support and connection between participants of the program.

BEAM - Infant; BEAM - Preschool

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only mothers and other primary caregivers who identify as women (e.g., grandmothers, aunts) are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a 6-36 months old child
• Must have moderate-severe depression (i.e., a score of 10+ on the Patient Health Questionnaire)
• + years of age
• comfortable understanding, speaking, and reading English
• Living in Manitoba or Alberta
• Must be available for weekly Zoom sessions

You may not qualify if:

• Child is outside the 6-36 month age range
• Lives outside of Manitoba or Alberta
• Does not meet criteria for moderate-severe depression
• A history of attempted suicide in past year or self-harm in past 6 months), or significant suicidal ideation.

Sponsors & Collaborators

• University of Manitoba: lead
• University of Calgary: collaborator
• Tactica Interactive: collaborator
• Centre for Healthcare Innovation: collaborator
• Research Manitoba: collaborator

Study Sites (1)

The University of Manitoba - Department of Psychology

Winnipeg, Manitoba, R3T 2N2, Canada

RECRUITING

Related Publications (2)

• Xie EB, Freeman M, Penner-Goeke L, Reynolds K, Lebel C, Giesbrecht GF, Rioux C, MacKinnon A, Sauer-Zavala S, Roos LE, Tomfohr-Madsen L. Building Emotional Awareness and Mental Health (BEAM): an open-pilot and feasibility study of a digital mental health and parenting intervention for mothers of infants. Pilot Feasibility Stud. 2023 Feb 18;9(1):27. doi: 10.1186/s40814-023-01245-x.

  PMID: 36800982 DERIVED

• 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 DERIVED

Central Study Contacts

Leslie E. Roos, PhD

CONTACT

204-474-7400; leslie.roos@umanitoba.ca

Lianne Tomfohr-Madsen, PhD

CONTACT

403-220-2243; ltomfohr@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study will include two arms. The first arm will enroll 30 mothers with children aged 6-17 months (i.e., infant cohort). The second arm will enroll 30 mothers with children aged 18-36 months (i.e., preschool cohort). The postpartum cohort will receive access to the online psychoeducation and social-connection platform and the preschool cohort will be randomized to the program or a services as usual control group. Analyses will be performed separately per each arm.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: May 5, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)