Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically impacted the lives of children/adolescents (children) and families. The closure of schools, social and recreational activities, and modifications to work environments has led to significant changes in the way children and families are working, living and socializing. Although the impact on the mental health of children and families has not been well researched, it is anticipated that already stressed children and families with pre-COVID-19 mental health challenges are at significant risk for deterioration in their mental health. As such, the implementation, and evaluation (specifically: feasibility, acceptability and barriers) of virtual-care interventions to alleviate child and family anxiety and enhance family functioning are critical. Virtual-care also optimizes health equity initiatives in reducing social, economic and environmental barriers to services that can improve or maintain mental health (WHO, 2017; MOHLTC, 2018). The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility, participation barriers related to social determinants of health (SDH) and acceptability of this virtual-care intervention in addressing mental health challenges associated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this virtual-care intervention will enable future scale-up of this intervention during the post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.
Study Design: This is a pragmatic prospective pre-post feasibility study to assess whether
virtual-care delivery of mental health interventions are acceptable and feasible with regard
to recruitment and retention, participation barriers (inclusive of SDH barriers), child and
parent acceptability, and adherence. Targeted symptoms of the intervention (e.g., child
anxiety) will be evaluated as secondary outcomes to gather preliminary data on efficacy.
Estimated Sample Size: In this first feasibility phase, participants will include children
referred for treatment to Psychiatry. For the purpose of this pragmatic trial, we aim to
recruit 20 participants for this intervention. According to Hertzog, a sample size of 20
participants is adequate for pilot studies to examine intervention feasibility and to develop
estimates of variance to compute power for larger studies (Hertzog, 2008).
Data Analyses: Data for demographic variables will be summarized using counts, percentages,
measures of central tendency (mean, median, and mode) and measures of sample variation
(standard deviation, range). Parametric statistics (mean, standard deviation) will be used
for interval and ratio data. To assess the feasibility and acceptability of this
intervention, results will include analyses of recruitment, social determinant barriers and
adherence rates and responses to satisfaction/evaluation and alliance scales. Pre-post
analysis will also include comparing mean changes in COVID specific distress, and
intervention specific comparisons of child anxiety.
Knowledge Translation: Our integrated Knowledge-to-action (iKTA) approach has involved
family, clinician and scientist engagement from the outset and will continue to do so.
Participants will receive updates through e-newsletters and information through email.
Knowledge gained will be presented at conferences and publications to further the impact of
generating future hypothesis-driven research and funding support.
Behavioral: Virtual-Care Cognitive Behavioural Therapy
The feasibility, participation barriers, and acceptability of the intervention, virtual-care cognitive behavioural therapy (VC-CBT), will be evaluated for children with anxiety. The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.
Inclusion Criteria:
- Ages 12 to 17 years old
- Meet criteria for anxiety disorder as primary diagnosis
- Parent(s)/primary caregiver(s) and children both proficient in English
Exclusion Criteria:
- Diagnosis of developmental delay
- Severity of comorbid psychopathology (e.g., bipolar disorder, psychosis) prohibits CBT
as first-line treatment
- Lack of fluency in English (for parent(s)/primary caregiver(s) and/or children)
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
Suneeta Monga, MD, FRCPC, Principal Investigator
The Hospital for Sick Children (SickKids)