Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05306626
Other study ID # BEAM toddler RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date November 1, 2022

Study information

Verified date March 2022
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the COVID-19 pandemic, the prevalence of maternal depression and anxiety has increased and research suggests that the cognitive development of children born during the pandemic has been impacted. There are significant concerns that a cohort of children may be at-risk for mental illness and impaired self-regulation due to elevated exposure to perinatal maternal mental illness. Intervention is crucial as the intergenerational effects of maternal mental illness are most pronounced when mental health concerns persist. There is currently an urgent need for accessible eHealth interventions for mothers of young children as the pandemic has contributed to an increased prevalence of mental health concerns and to additional barriers to services. The Building Emotion Awareness and Mental Health (BEAM) app-based program was developed to help address maternal mental health concerns and parenting stress. A two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to treatment as usual (TAU) among a sample of 140 mothers who self-report moderate-to-severe symptoms of depression and/or anxiety and have a child 18 to 36 months-old.


Description:

Maternal mental health symptoms in the first few years following childbirth are common and can have contributed to adverse consequences for both mother and baby. Two of the most common perinatal mental health concerns are depression and anxiety. The COVID-19 pandemic has introduced heightened stressors for families, including physical isolation from support and social networks, additional childcare responsibilities, and economic uncertainty. Unsurprisingly, the pandemic has also led to an increased prevalence of maternal depression and anxiety in Canada and around the world. These mental health problems are associated with increased health problems and low quality of life for mothers. The COVID-19 pandemic has also posed additional challenges to families and mothers with young children are experiencing heightened parenting stress, increasing their support needs. For mothers with depression, these additional parenting stressors can worsen the symptoms and severity their depression. Furthermore, emerging research suggests that the COVID-19 pandemic has had detrimental effects on early child cognitive development. According to the developmental origins of health and disease, exposure to maternal depression in the first 5 years of life is linked to children's mental illness, cognitive impairments, and developmental delays. Intervening early is important to help prevent negative long-term consequences for mothers and their children. Without treatment, maternal depressive symptoms tend to remain consistent throughout the preschool years and the adverse consequences of maternal mental health concerns are most pronounced when depression persists. Although there are evidence-based treatments to address maternal mental illness, accessing care can be challenging due to the exceedingly high barriers to service due to COVID-19, such as lack of childcare and time. Web-based resources have been identified as a preference for mental health support by mothers with mental health problems during the perinatal period. Furthermore, mothers have expressed appreciation for peer support during the perinatal period as social support is often highly relied upon in the postnatal period to care for their infants and themselves. Support from other mothers, specifically, has been found to be helpful in recovering from postpartum depression and individuals report higher satisfaction in treatments of postpartum depression that include a peer support component. E-health interventions, designed to target both maternal mental illness and parenting abilities, and that prioritize social support, may be a promising avenue to address the intergenerational impact of perinatal mental health problems. The Building Emotion Awareness and Mental Health (BEAM) program is an app-based and online group therapy program that was developed to respond to the high needs of mothers managing depression, anxiety, and parenting stress. There are 3 objectives for this study: Evaluate the efficacy of the BEAM app-based program for improving depression compared to a treatment as usual (TAU) control group. Examine the benefits of BEAM for family relationships, anxiety, parenting stress and behaviours, and child functioning. Examine exploratory outcomes of parent-child relationship quality, maternal sensitivity, and child emotional reactivity.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date November 1, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A mother with a child aged 18-36 months old - Moderate-to-severe symptoms of depression and/or anxiety (i.e., a score at or above 10 on the Patient Health Questionnaire and/or the General Anxiety Disorder scale - Comfortable understanding, speaking, and reading English - Live in Manitoba or Alberta, Canada - Be available to attend weekly telehealth sessions - Consent to wearing a Fitbit - Complete baseline screener and questionnaire and be willing to meet the research team through Zoom (either during assessment or technology check in session). Exclusion Criteria - Child is outside of the 18-36 month age range - Does not meet criteria for moderate-to-severe depression and/or anxiety - Lives outside of Manitoba or Alberta - A reported history of attempted suicide in the past year or self-harm in the past 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Building Emotion Awareness and Mental Health (BEAM)
The BEAM Program is based on best-practices in telehealth and science-based program design principles aimed at promoting maternal mental health and supportive parenting. The BEAM Program mobile application is designed and managed by Tactica Interactive and hosted on the University of Manitoba secure servers. The weekly group telehealth sessions will be led by clinical coaches (a mental health professional or trainee) and will use the secure videoconferencing platform Zoom (Healthcare license). Parent coaches will be mothers who have recently participated in another research group-based mental health intervention. Parent coaches will engage with participants on the community peer support forum and attend weekly telehealth sessions. The therapeutic aims of the BEAM program are to improve anxiety and depression symptoms and parenting skills using content that draws from the Unified Protocol, and emphasizes self-compassion, effective communication practices, and social support networks.

Locations

Country Name City State
Canada The University of Manitoba - Department of Psychology Winnipeg Manitoba

Sponsors (5)

Lead Sponsor Collaborator
University of Manitoba Centre for Healthcare Innovation, Research Manitoba, Tactica Interactive, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in parent-child relationship quality Parent-child relationship quality will be assessed by coding online video observation To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in sensitive parenting Sensitive parenting will be assessed by coding online video observation To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in child emotional reactivity Child emotional reactivity will be assessed by coding online video observation To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in heart rate Heart rate will be assessed using Fitbit devices To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in sleep duration Sleep duration will be assessed using Fitbit devices To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in sleep quality Sleep quality will be assessed using Fitbit devices To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Change in physical activity Physical activity will be assessed via step count using Fitbit devices To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Other Feasibility of the BEAM program Feasibility of the BEAM program will be assessed using the mHelath App Usability Questionnaire (MAUQ), a self-report measure with three subscales that rate, on a 7-point Likert scale, 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 pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Primary Change in depression symptoms Symptoms of depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a self-administered questionnaire with possible scores ranging from 0 to 27, where higher scores are indicative of more severe symptoms. A cut-off score of = 10 will be used to identify participants who present with clinically concerning symptoms of depression. The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in parental assistance with child emotion regulation Parental assistance with child emotion regulation will be measured using the Parental Assistance with Child Emotion Regulation scale (PACER). The PACER is a parent-report measure of how parents assist children with regulation of emotion using specific strategies. Scores range from 50-350, where higher scores indicate higher engagement in behaviours that support child emotion regulation. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in partner social support Partner social support will be measured using the Social Support Effectiveness Questionnaire (SSE). The SSE is a self-report measure of partner social support effectiveness .Total scores can range from 0 to 80, with higher scores indicating more effective support. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in romantic relationship satisfaction Romantic relationship satisfaction will be measured using the 4-item Couple Satisfaction Index (CSI-4). The CSI is a self-report measure of the individual's global evaluations of their romantic relationship. Scores range from 0 to 21, with higher scores reflecting higher levels of satisfaction. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in parenting stress Parenting stress will be measured using the Parenting Stress Index (PSI), a self-report measure of parenting stress and interactional style across 3 subscales (parent distress, parent-child dysfunction, difficult child) which combine to form a Total Stress scale. Raw scores range from 36 to 180, with higher scores indicating higher levels of parent stress. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in parenting discipline practices Parenting behaviour and dysfunctional discipline will be measured using the Parenting Scale (PS), a self-rating scale to measure discipline practices in parents of young children. Scores range from 30-210, with higher scores indicating more ineffective parenting discipline practices. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in parenting behaviours Parenting behaviours will be measured using the Parenting Young Children (PARYC) measure, a self-report of parenting strategies/behaviours relevant for caregivers of young children. Scores range from 21-105, with higher scores indicating more proactive parenting behaviours. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in anxiety symptoms Maternal anxiety will be measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale, a self-rating scale to measure anxiety. Scores range from 0-21, with higher scores indicating higher levels of anxiety. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in anger Anger will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1-Anger 5a, a self-report measure to assess the severity and frequency of an individual's anger. Scores range from 5-25, where higher scores indicate more anger. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in self-compassion Self-compassion will be measured using the Self-Compassion Scale Short-Form (SCS-SF), a self-report measure of self-compassion. Scores range from 12-60, with higher scores indicating higher levels of self-compassion. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in sleep problems Sleep disturbance will be measured using the PROMIS Sleep Disturbance Scale, a self-report of perceptions of sleep quality, depth, and restoration with the past seven days. Scores range from 8-40, with higher scores indicating greater severity of sleep disturbance. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in suicidal ideation severity Suicidal ideation severity will be measured using the Depression Symptom Index Suicidality Subscale (DSI-SS), a self-report measure of suicidal ideation. Scores range from 0 to 12, where higher scores indicate higher suicidal ideation. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in self-esteem Self-esteem will be measured using the Single Item Self-Esteem Scale (SISE), a one-item self-report measure of global self-esteem. Scores range from 1 to 7, where higher scores indicate higher self-esteem. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in alcohol use Alcohol use will be measured using the Alcohol Use Disorder Identification Test (AUDIT), a self-report measure of alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0 to 40, where higher scores indicate more hazardous alcohol use. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in cannabis use Cannabis use will be measured using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R), a self-report of cannabis misuse. Scores range from 0 to 32, where higher scores indicate more hazardous cannabis use and scores of 12 or more indicating a possible Cannabis Use Disorder. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in child emotional and behavioural problems Child emotional and behavioural problems will be measured using the Preschool Pediatric Symptom Checklist (PPSC), a parent report measure of early emotional and behavioural problems in infants and pre-schoolers. Scores range from 0 to 34, where higher scores indicate higher incidence of emotional and behavioural problems To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
Secondary Change in child temperament Child temperament will be measured using a subset of questions from the Early Child Behavior Questionnaire (ECBQ), a parent report measure of temperament in children aged 1 to 3. Scores range from 1 to 7, where higher scores indicate higher levels of the temperamental trait. To be assessed pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3)
See also
  Status Clinical Trial Phase
Completed NCT04122482 - An Online Course for Improving Knowledge and Access to Mental Health Accommodations in Canadian Enterprises N/A
Completed NCT04085861 - Mental Health in Dancers; an Intervention Study N/A
Recruiting NCT06060210 - Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion Phase 4
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Recruiting NCT06065787 - NeuroGlove Anxiety and Depression Study N/A
Active, not recruiting NCT04583891 - Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design N/A
Completed NCT05554042 - Kintsugi Voice Device Study
Not yet recruiting NCT06430853 - Psychobiological Interventions in Pregnancy N/A
Not yet recruiting NCT06162624 - Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons N/A
Completed NCT02954250 - Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide Early Phase 1
Recruiting NCT05647499 - Evaluating the Back 2 School Program in a Norwegian Setting: A Multicenter Pilot Study N/A
Completed NCT03980873 - Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach N/A
Completed NCT04422327 - The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome Phase 1/Phase 2
Completed NCT05368155 - Chronic Pelvic Pain and Education Skills Training for Women Veterans N/A
Completed NCT05455905 - Voice Biomarkers Predictive of Depression and Anxiety
Completed NCT03272516 - Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients N/A
Not yet recruiting NCT05493865 - Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems N/A
Not yet recruiting NCT06027047 - Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Not yet recruiting NCT05535101 - Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A