Building Emotional Awareness and Mental Health (BEAM) 2024-2027

NCT06455397 | Recruiting

• 1 other identifier: BEAM 2024-2027
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Children are highly sensitive to adversity during their first five years of life, with exposure to chronic parental mental illness (MI) consistently linked to socio-emotional impairments and mental health problems in children. Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress, with parental MI reported at three times the pre-pandemic rates. This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children. In response, the investigators developed the Building Emotional Awareness and Mental Health (BEAM) program, an innovative mobile health (mHealth) solution for parents of young children. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. This trial involves an effectiveness-implementation hybrid design with co-primary aims of (1) determining BEAM's effectiveness in improving child mental health and developmental outcomes, and (2) evaluating the implementation of BEAM in the community through metrics such as feasibility, acceptability, and uptake. The secondary aim of this trial is to measure BEAM's effectiveness in improving long-term biopsychosocial family outcomes using administrative data. A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming. This trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app, with access to an online social support forum and check ins with a peer coach. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4). Beginning in 2025, the trial offers participants the option to invite one parenting partner to join them in the program. A parenting partner is defined as a co-parent (e.g., the child's mother, father, or step-parent) or another primary caregiver (e.g., a grandparent, cousin, uncle, or aunt). Each participant may invite one such individual, hereafter referred to as a "co-parent." Co-parents will have access to the BEAM intervention and all its features, with the exception of peer coaching. Co-parents will be eligible to complete the same outcome measures at the same timepoints as participants. Three differences that will separate co-parents from participants are: (1) co-parents will not be asked to complete the ASQ:2-SE or ASQ-3 secondary outcome measures; (2) co-parents will not have access to peer coaching, and (3) co-parents will not be required to be experiencing moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger. (Please see Eligibility \> Eligibility Criteria for the less restrictive inclusion and exclusion criteria for co-parents.) Co-parents will not be counted toward the trial sample size of n=400, and will not be included in primary analyses. Instead, co-parent data will be used in sub-studies to address exploratory research questions. The BEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related child functioning concerns. The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program, in a next step of testing BEAM's readiness for nationwide scaling.

Conditions

Depression, Anxiety; Anger; Parenting; Stress, Psychological; Parent-Child Relations; Child Development

Keywords

Parenting; Mental health; Depression; Anxiety; Psychoeducation; App-based intervention

Outcome Measures

Primary Outcomes (3)

• Change in parent mental health symptom composite.

  The parent mental health composite score will be defined uniquely for each participant using a weighted average of their pre-intervention (T1) mental health profile (i.e., self-report symptoms of depression, anxiety, anger, sleep problems, and parenting stress). Pre-intervention symptoms above established clinical cut-offs will be mean-centred, standardized, and included in the participant's composite mental health symptom score weighted by the symptom's pre-intervention severity. In this way, the primary outcome will track mean change in each participant's most clinically elevated pre-intervention symptoms. This composite will use validated measures of depression symptom severity (Patient Health Questionnaire-9), anxiety symptom severity (Generalized Anxiety Disorder-7), anger (PROMIS Anger), sleep disturbances (PROMIS Sleep Disturbance), and parenting stress (Parenting Stress Index - 4th Edition - Short Form). Change in each measure is also a secondary outcome, described below.

  All measures to be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Feasibility of the BEAM program.

  Feasibility of the BEAM program will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ is a self-report measure with three subscales that rate ease of use (scores range from 5-35), interface and satisfaction (scores range from 7-49), and usefulness (scores range from 6-42), where high scores indicate better useability.

  To be assessed immediately after intervention (T2).

• Acceptability and uptake of the BEAM program.

  Acceptability and uptake of the BEAM program will be assessed in three ways: (1) rates of attrition, (2) qualitative analysis of responses to post-intervention focus group questions that probe barriers and facilitators to program engagement, and (3) program engagement measures from back-end app data (e.g., number of logins, time spent on the app, forum posts, coach engagement, drop-in session engagement, and systems navigator engagement).

  To be assessed pre-intervention (T1), during intervention, and immediately after intervention (T2).

Secondary Outcomes (11)

• Change in parent depressive symptoms.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Change in parent anxiety symptoms.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Change in parent anger symptoms.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Change in parent sleep problems.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Change in parent alcohol use.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

Other Outcomes (6)

• Change in parenting self-efficacy.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Change in social support.

  To be assessed pre-intervention (T1), immediately after intervention (T2), at 6-month follow-up (T3), and at 12-month follow-up (T4).

• Discriminatory experiences.

  To be assessed pre-intervention (T1).

Study Arms (1)

The BEAM Program Group

EXPERIMENTAL

All study participants will complete 12 weeks of the BEAM program. Each week of BEAM includes: (a) 15-20 minutes of therapeutic mental health and parenting video content, (b) exercises to practice key skills, (c) access to the online forum to cultivate social support through interaction with other parents and peer coaches, (d) individual check ins with peer coaches (i.e., trained and supervised staff with lived experience) via Zoom for Healthcare, phone, or direct messaging, and (e) a brief in-app survey for symptom monitoring to track progress. Participants will also be invited to virtual group drop-in sessions facilitated by peer coaches and be connected with a systems navigator who can support participants in accessing other community resources (e.g., childcare programs, legal aid, housing). Co-parents will have access to all components of the BEAM program except for (d).

Behavioral: The Building Emotional Awareness and Mental Health (BEAM) Program

Interventions

The Building Emotional Awareness and Mental Health (BEAM) Program BEHAVIORAL

The BEAM Program builds on mHealth best practices and evidence-based program design principles with the core objectives of improving maternal mental health and fostering supportive parenting. Program content draws on transdiagnostic emotion-focused mental health and third wave Cognitive Behavioural Therapy principles such as Dialectical Behavioural Therapy, Acceptance and Commitment Therapy, and the Unified Protocol. Program delivery will be facilitated through a mobile application. The BEAM program uses a stepped care model to address the pressing need for accessible and effective mental health interventions. Stepped care is a framework that provides mental health services in a tiered manner, ensuring that participants receive appropriate levels of support based on the severity of needs. At the heart of this model are BEAM peer coaches, who will have the most direct contact with participants. Peer coaches are trained to escalate concerns to the program clinical team as required.

The BEAM Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe symptoms of depression, anxiety, parenting stress, and/or anger (as measured by the PHQ-9, GAD-7, PSI, and PROMIS-Anger). Those who do not have moderate to severe symptoms will meet with a member of the program research team to determine eligibility. This eligibility decision will be based on clinical judgement, ensuring that those with need can participate.
• Being a parent or primary caregiver of any gender to an 24- to 71-month-old (i.e., 2-5 year old) child.
• Living in Manitoba.
• Able to participate in check ins (15 to 60 minutes) via Zoom, phone, direct messaging with a parent peer coach.
• years or older.
• Able to understand/read/speak in English.
• Willing to complete four 45-min questionnaires.
• At eligibility screening, a question asks if participants have access to an electronic device for viewing videos and participating in Zoom meetings. Participants who do not have access will be asked to contact the research team. The team may be able to accommodate a limited number of participants by providing relevant devices for the duration of the study.
• Participants have IP addresses within Manitoba, Canada, as determined by IP address in REDCap at time of eligibility screener questionnaire completion. Participants will be required to securely upload a photo that includes both a valid piece of Manitoba government identification and the participant's face (i.e., a 'selfie').

You may not qualify if:

• Living outside of Manitoba.
• Being a parent or primary caregiver to a child outside of the ages of 24- to 71-months (i.e., 2-5 years).
• Previously participated in an earlier BEAM trial.
• Parents who report self-harm that required medical attention within the past six months or a suicide attempt within the past year will be ineligible to participate in BEAM unless the participant is engaged in individual therapy that attends to this acute risk level with one of the following professionals for the duration of the BEAM program: psychiatrist, psychologist, social worker, or psychotherapist. The research team will email all prospective participants who are pending eligibility to schedule a phone call. This call will determine whether it is feasible to connect the participant with an individual therapist to manage specific needs before engaging in the BEAM program, and discuss if the BEAM program is the right fit for the participant's present needs.

Sponsors & Collaborators

• Leslie E. Roos: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Manitoba Centre for Health Policy: collaborator
• George & Fay Yee Centre for Healthcare Innovation: collaborator
• Children's Hospital Research Institute of Manitoba: collaborator
• Family Dynamics, Manitoba, Canada: collaborator

Study Sites (1)

University of Manitoba - Department of Psychology & Pediatrics

Winnipeg, Manitoba, R3T 2N2, Canada

RECRUITING

Related Publications (73)

• Keller PS, Kouros CD, Erath SA, Dahl RE, El-Sheikh M. Longitudinal relations between maternal depressive symptoms and child sleep problems: the role of parasympathetic nervous system reactivity. J Child Psychol Psychiatry. 2014;55(2):172-9. doi: 10.1111/jcpp.12151. Epub 2013 Oct 9.

  PMID: 24117807 BACKGROUND

• McGrath JM, Records K, Rice M. Maternal depression and infant temperament characteristics. Infant Behav Dev. 2008 Jan;31(1):71-80. doi: 10.1016/j.infbeh.2007.07.001. Epub 2007 Aug 21.

  PMID: 17714790 BACKGROUND

• Skipstein A, Janson H, Kjeldsen A, Nilsen W, Mathiesen KS. Trajectories of maternal symptoms of depression and anxiety over 13 years: the influence of stress, social support, and maternal temperament. BMC Public Health. 2012 Dec 27;12:1120. doi: 10.1186/1471-2458-12-1120.

  PMID: 23270506 BACKGROUND

• Mensah FK, Kiernan KE. Parents' mental health and children's cognitive and social development: families in England in the Millennium Cohort Study. Soc Psychiatry Psychiatr Epidemiol. 2010 Nov;45(11):1023-35. doi: 10.1007/s00127-009-0137-y. Epub 2009 Oct 13.

  PMID: 19823757 BACKGROUND

• Goodman SH, Rouse MH, Connell AM, Broth MR, Hall CM, Heyward D. Maternal depression and child psychopathology: a meta-analytic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):1-27. doi: 10.1007/s10567-010-0080-1.

  PMID: 21052833 BACKGROUND

• Kingston D, Kehler H, Austin MP, Mughal MK, Wajid A, Vermeyden L, Benzies K, Brown S, Stuart S, Giallo R. Trajectories of maternal depressive symptoms during pregnancy and the first 12 months postpartum and child externalizing and internalizing behavior at three years. PLoS One. 2018 Apr 13;13(4):e0195365. doi: 10.1371/journal.pone.0195365. eCollection 2018.

  PMID: 29652937 BACKGROUND

• Azak S, Raeder S. Trajectories of parenting behavior and maternal depression. Infant Behav Dev. 2013 Jun;36(3):391-402. doi: 10.1016/j.infbeh.2013.03.004. Epub 2013 Apr 17.

  PMID: 23603820 BACKGROUND

• Vliegen N, Casalin S, Luyten P. The course of postpartum depression: a review of longitudinal studies. Harv Rev Psychiatry. 2014 Jan-Feb;22(1):1-22. doi: 10.1097/HRP.0000000000000013.

  PMID: 24394219 BACKGROUND

• Moreno C, Wykes T, Galderisi S, Nordentoft M, Crossley N, Jones N, Cannon M, Correll CU, Byrne L, Carr S, Chen EYH, Gorwood P, Johnson S, Karkkainen H, Krystal JH, Lee J, Lieberman J, Lopez-Jaramillo C, Mannikko M, Phillips MR, Uchida H, Vieta E, Vita A, Arango C. How mental health care should change as a consequence of the COVID-19 pandemic. Lancet Psychiatry. 2020 Sep;7(9):813-824. doi: 10.1016/S2215-0366(20)30307-2. Epub 2020 Jul 16.

  PMID: 32682460 BACKGROUND

• Hansen AS, Telleus GK, Mohr-Jensen C, Lauritsen MB. Parent-perceived barriers to accessing services for their child's mental health problems. Child Adolesc Psychiatry Ment Health. 2021 Jan 29;15(1):4. doi: 10.1186/s13034-021-00357-7.

  PMID: 33514400 BACKGROUND

• Sztein DM, Koransky CE, Fegan L, Himelhoch S. Efficacy of cognitive behavioural therapy delivered over the Internet for depressive symptoms: A systematic review and meta-analysis. J Telemed Telecare. 2018 Sep;24(8):527-539. doi: 10.1177/1357633X17717402. Epub 2017 Jul 11.

  PMID: 28696153 BACKGROUND

• Larkin F, Oostenbroek J, Lee Y, Hayward E, Meins E. Proof of concept of a smartphone app to support delivery of an intervention to facilitate mothers' mind-mindedness. PLoS One. 2019 Aug 22;14(8):e0220948. doi: 10.1371/journal.pone.0220948. eCollection 2019.

  PMID: 31437173 BACKGROUND

• Catuara-Solarz S, Skorulski B, Estella-Aguerri I, Avella-Garcia CB, Shepherd S, Stott E, Hemmings NR, Ruiz de Villa A, Schulze L, Dix S. The Efficacy of "Foundations," a Digital Mental Health App to Improve Mental Well-being During COVID-19: Proof-of-Principle Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jul 1;10(7):e30976. doi: 10.2196/30976.

  PMID: 34978535 BACKGROUND

• Roos LE, Kaminski L, Stienwandt S, Hunter S, Giuliano R, Mota N, Katz LY, Zalewski M. The Building Regulation in Dual-Generations Program (BRIDGE): A Mixed-Methods Feasibility Pilot of a Parenting Program for Depressed Mothers of Preschoolers, Matched with Dialectical Behavior Therapy Skills. Child Psychiatry Hum Dev. 2023 Feb;54(1):34-50. doi: 10.1007/s10578-021-01219-1. Epub 2021 Aug 4.

  PMID: 34347227 BACKGROUND

• Cameron EE, Simpson KM, Pierce SK, Penner KE, Beyak A, Gomez I, Bowes JM, Reynolds KA, Tomfohr-Madsen LM, Roos LE. Paternal Perinatal Experiences during the COVID-19 Pandemic: A Framework Analysis of the Reddit Forum Predaddit. Int J Environ Res Public Health. 2023 Mar 1;20(5):4408. doi: 10.3390/ijerph20054408.

  PMID: 36901417 BACKGROUND

• MacKinnon AL, Silang K, Penner K, Zalewski M, Tomfohr-Madsen L, Roos LE. Promoting Mental Health in Parents of Young Children Using eHealth Interventions: A Systematic Review and Meta-analysis. Clin Child Fam Psychol Rev. 2022 Sep;25(3):413-434. doi: 10.1007/s10567-022-00385-5. Epub 2022 Feb 20.

  PMID: 35184262 BACKGROUND

• Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.

  PMID: 28768327 BACKGROUND

• Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

  PMID: 22697453 BACKGROUND

• Spence SH, March S, Donovan CL. Social support as a predictor of treatment adherence and response in an open-access, self-help, internet-delivered cognitive behavior therapy program for child and adolescent anxiety. Internet Interv. 2019 Aug 22;18:100268. doi: 10.1016/j.invent.2019.100268. eCollection 2019 Dec.

  PMID: 31890621 BACKGROUND

• Yardley L, Spring BJ, Riper H, Morrison LG, Crane DH, Curtis K, Merchant GC, Naughton F, Blandford A. Understanding and Promoting Effective Engagement With Digital Behavior Change Interventions. Am J Prev Med. 2016 Nov;51(5):833-842. doi: 10.1016/j.amepre.2016.06.015.

  PMID: 27745683 BACKGROUND

• Silang KA, Sohal PR, Bright KS, Leason J, Roos L, Lebel C, Giesbrecht GF, Tomfohr-Madsen LM. eHealth Interventions for Treatment and Prevention of Depression, Anxiety, and Insomnia During Pregnancy: Systematic Review and Meta-analysis. JMIR Ment Health. 2022 Feb 21;9(2):e31116. doi: 10.2196/31116.

  PMID: 35188471 BACKGROUND

• Swift JK, Greenberg RP. Premature discontinuation in adult psychotherapy: a meta-analysis. J Consult Clin Psychol. 2012 Aug;80(4):547-59. doi: 10.1037/a0028226. Epub 2012 Apr 16.

  PMID: 22506792 BACKGROUND

• 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 BACKGROUND

• 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

• Landes SJ, McBain SA, Curran GM. Reprint of: An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2020 Jan;283:112630. doi: 10.1016/j.psychres.2019.112630. Epub 2019 Nov 10.

  PMID: 31722790 BACKGROUND

• Knapp M, Wong G. Economics and mental health: the current scenario. World Psychiatry. 2020 Feb;19(1):3-14. doi: 10.1002/wps.20692.

  PMID: 31922693 BACKGROUND

• McBrien KA, Manns B. Approach to economic evaluation in primary care: review of a useful tool for primary care reform. Can Fam Physician. 2013 Jun;59(6):619-27.

  PMID: 23766042 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Joint Task Force for the Development of Telepsychology Guidelines for Psychologists. Guidelines for the practice of telepsychology. Am Psychol. 2013 Dec;68(9):791-800. doi: 10.1037/a0035001. No abstract available.

  PMID: 24341643 BACKGROUND

• Schueller SM, Neary M, Lai J, Epstein DA. Understanding People's Use of and Perspectives on Mood-Tracking Apps: Interview Study. JMIR Ment Health. 2021 Aug 11;8(8):e29368. doi: 10.2196/29368.

  PMID: 34383678 BACKGROUND

• Linardon J, Cuijpers P, Carlbring P, Messer M, Fuller-Tyszkiewicz M. The efficacy of app-supported smartphone interventions for mental health problems: a meta-analysis of randomized controlled trials. World Psychiatry. 2019 Oct;18(3):325-336. doi: 10.1002/wps.20673.

  PMID: 31496095 BACKGROUND

• Gan DZQ, McGillivray L, Han J, Christensen H, Torok M. Effect of Engagement With Digital Interventions on Mental Health Outcomes: A Systematic Review and Meta-Analysis. Front Digit Health. 2021 Nov 4;3:764079. doi: 10.3389/fdgth.2021.764079. eCollection 2021.

  PMID: 34806079 BACKGROUND

• Hanish AE, Lin-Dyken DC, Han JC. PROMIS Sleep Disturbance and Sleep-Related Impairment in Adolescents: Examining Psychometrics Using Self-Report and Actigraphy. Nurs Res. 2017 May/Jun;66(3):246-251. doi: 10.1097/NNR.0000000000000217.

  PMID: 28448375 BACKGROUND

• Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

  PMID: 8329970 BACKGROUND

• Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.

  PMID: 20347232 BACKGROUND

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 BACKGROUND

• Vaishnavi S, Connor K, Davidson JR. An abbreviated version of the Connor-Davidson Resilience Scale (CD-RISC), the CD-RISC2: psychometric properties and applications in psychopharmacological trials. Psychiatry Res. 2007 Aug 30;152(2-3):293-7. doi: 10.1016/j.psychres.2007.01.006. Epub 2007 Apr 25.

  PMID: 17459488 BACKGROUND

• Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.

  PMID: 27239096 BACKGROUND

• Orpana HM, Lang JJ, Yurkowski K. Validation of a brief version of the Social Provisions Scale using Canadian national survey data. Health Promot Chronic Dis Prev Can. 2019 Dec;39(12):323-332. doi: 10.24095/hpcdp.39.12.02.

  PMID: 31825785 BACKGROUND

• Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.

  PMID: 18179329 BACKGROUND

• Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305.

  PMID: 22013026 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. Correction: 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 30;23(1):832. doi: 10.1186/s13063-022-06760-5. No abstract available.

  PMID: 36180923 BACKGROUND

• Narayan AJ, Rivera LM, Bernstein RE, Harris WW, Lieberman AF. Positive childhood experiences predict less psychopathology and stress in pregnant women with childhood adversity: A pilot study of the benevolent childhood experiences (BCEs) scale. Child Abuse Negl. 2018 Apr;78:19-30. doi: 10.1016/j.chiabu.2017.09.022. Epub 2017 Oct 6.

  PMID: 28992958 BACKGROUND

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

  PMID: 9635069 BACKGROUND

• Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.

  PMID: 30973342 BACKGROUND

• Mallinckrodt B, Tekie YT. Item response theory analysis of Working Alliance Inventory, revised response format, and new Brief Alliance Inventory. Psychother Res. 2016 Nov;26(6):694-718. doi: 10.1080/10503307.2015.1061718. Epub 2015 Nov 7.

  PMID: 26549302 BACKGROUND

• Smith JD, Stormshak EA, Kavanagh K. Results of a pragmatic effectiveness-implementation hybrid trial of the Family Check-up in community mental health agencies. Adm Policy Ment Health. 2015 May;42(3):265-78. doi: 10.1007/s10488-014-0566-0.

  PMID: 24927926 BACKGROUND

• Flight L, Allison A, Dimairo M, Lee E, Mandefield L, Walters SJ. Recommendations for the analysis of individually randomised controlled trials with clustering in one arm - a case of continuous outcomes. BMC Med Res Methodol. 2016 Nov 29;16(1):165. doi: 10.1186/s12874-016-0249-5.

  PMID: 27899073 BACKGROUND

• Wall-Wieler E, Roos LL, Nickel NC, Chateau D, Brownell M. Mortality Among Mothers Whose Children Were Taken Into Care by Child Protection Services: A Discordant Sibling Analysis. Am J Epidemiol. 2018 Jun 1;187(6):1182-1188. doi: 10.1093/aje/kwy062.

  PMID: 29617918 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.

  PMID: 20352064 BACKGROUND

• Kwok OM, Underhill AT, Berry JW, Luo W, Elliott TR, Yoon M. Analyzing Longitudinal Data with Multilevel Models: An Example with Individuals Living with Lower Extremity Intra-articular Fractures. Rehabil Psychol. 2008 Aug;53(3):370-386. doi: 10.1037/a0012765.

  PMID: 19649151 BACKGROUND

• Archibald M, Wiebe S, Rieger K, Linton J, Woodgate R. Protocol for a systematic review of living labs in healthcare. BMJ Open. 2021 Feb 5;11(2):e039246. doi: 10.1136/bmjopen-2020-039246.

  PMID: 33550226 BACKGROUND

• Archibald MM, Wittmeier K, Gale M, Ricci F, Russell K, Woodgate RL. Living labs for patient engagement and knowledge exchange: an exploratory sequential mixed methods study to develop a living lab in paediatric rehabilitation. BMJ Open. 2021 May 4;11(5):e041530. doi: 10.1136/bmjopen-2020-041530.

  PMID: 33947723 BACKGROUND

• Kim J, Kim YL, Jang H, Cho M, Lee M, Kim J, Lee H. Living labs for health: an integrative literature review. Eur J Public Health. 2020 Feb 1;30(1):55-63. doi: 10.1093/eurpub/ckz105.

  PMID: 31169898 BACKGROUND

• Farmer AY, Lee SK. The effects of parenting stress, perceived mastery, and maternal depression on parent-child interaction. Journal of Social Service Research. 2011; 37(5): 516-525.

  BACKGROUND

• Lipscomb ST, Hatfield B, Lewis H, Goka-Dubose E, Fisher PA. Strengthening children's roots of resilience: Trauma-responsive early learning. Children and Youth Services Review. 2019; 107: 104510.

  BACKGROUND

• Lambert MJ, Harmon KL. The merits of implementing routine outcome monitoring in clinical practice. Clinical Psychology: Science and Practice. 2018; 25(4): e12268.

  BACKGROUND

• Arnold DS, O'Leary SG, Wolff LS, Acker MM. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993; 5(2): 137-144.

  BACKGROUND

• Rini C, Schetter CD, Hobel CJ, Glynn LM, Sandman CA. Effective social support: Antecedents and consequences of partner support during pregnancy. Personal Relationships. 2006; 13(2): 207-229.

  BACKGROUND

• Patton MQ. Qualitative research & evaluation methods. 3rd ed. Thousand Oaks: Sage; 2010.

  BACKGROUND

• Enders CK. Applied missing data analysis. 2nd ed. The Guilford Press; 2022.

  BACKGROUND

• Pierce S, de Castro Lima HL, Jain B, Reynolds KA, Tomfohr-Madsen LM, Roos LE. A unique role for social connextion in the COVID-19 pandemic; a qualitative analysis of parenting forums. Center for Open Science. Preprint posted online February 5, 2022.

  BACKGROUND

• Flannery J, Penner-Goeke L, Xie EB, Prince D, Simpson KM, Callaghan B, Tomfohr-Madsen L, Roos LE. Digital parent training RCT meta-analysis and semantic review. PsyArXiv. Preprint posted online January 15, 2021. osf.io/cpd9b

  BACKGROUND

• Roos LE, MacKinnon AL, Xie EB, Simpson KM, Rioux C, Reynolds KA, et al. Treating maternal mental health problems with an app-based program: A randomized control trial of BEAM, for mothers of young children. Submitted 2023.

  BACKGROUND

• Abidin RR. Parenting stress index. 4th Edition. Psychological Assessment Resources, Inc.; 2012.

  BACKGROUND

• Achenbach TM, Rescorla L. Manual for the ASEBA school-age forms & profiles: an integrated system of multi-informant assessment. Burlington, VT: ASEBA; 2001.

  BACKGROUND

• Squires J, Bricker DD, Twombly E. Ages & stages questionnaires, social-emotional (ASQ:SE-2TM)): a parent-completed child monitoring system for social-emotional behaviors. Second edition. Baltimore, Maryland: Brookes Publishing; 2015.

  BACKGROUND

• Simpson KM, McHardy RJW, Zhou JG, Levasseur-Puhach S, Cote CM, Braun M, Clement F, MacKinnon AL, Nickel N, Afifi TO, Giesbrecht GF, Giuliano R, Katz LY, Kelly LE, Klassen TP, Lebel C, Mushquash A, Reynolds K, Decaire E, Mughal W, Chartrand F, Kloss O, Hensel JM, Bolton JM, Unger JAM, Archibald M, Fisher P, Pharazyn A, Tomfohr-Madsen L, Roos LE. Building Emotional Awareness and Mental Health (BEAM): study protocol for a hybrid implementation-effectiveness trial of the BEAM app-based program for parents with clinical mental health problems. BMC Psychiatry. 2025 Jun 2;25(1):567. doi: 10.1186/s12888-025-06964-4.

  PMID: 40457257 DERIVED

Related Links

• Statistics Canada. Leading causes of death, total population, by age group \[Internet\]. Government of Canada; \[accessed 2024 Jan 14\]
• Health Canada. Canadian Community Health Survey, Cycle 2.2, Nutrition (2004): Income-related household food security in Canada. \[Internet\]. 2007
• Statistics Canada. Canadian housing survey, 2022. \[Internet\]. 2022

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress, Psychological; Psychological Well-Being

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Leslie E Roos, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie E Roos, PhD

CONTACT

2044747400; leslie.roos@umanitoba.ca

Maryem Zahra Project Coordinator, Bachelor of Arts (Hon)

CONTACT

Maryem.Zahra@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Departments of Psychology & Pediatrics

Model Details: All study participants will complete 12 weeks of the BEAM program. This involves weekly mental health and parenting education videos, app-based social support forum, and check ins with a peer parent coach. Participants will additionally have access to systems navigation to help participants find community supports. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4).

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 12, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)