Clinical trial NCT04408027: Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
Official title: Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorder of Childhood or Adolescence
Keywords: anxiety disorder
child
adolescent
virtual-care
cognitive behavioural therapy
COVID-19
mental health
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The current study will leverage an adapted virtual-care cognitive behavioural therapy program for children with anxiety (VC-CBT). 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participation Barriers
timeFrame: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).
measure: Number of Eligible Participants
timeFrame: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.
measure: Number of Participants Approached
timeFrame: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.
measure: Number of Participants Consented
timeFrame: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.
measure: Rates of Refusal
timeFrame: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
measure: Reasons for Refusal
timeFrame: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
measure: Number of Sessions Completed in Total
timeFrame: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.
measure: Adherence Index
timeFrame: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.
measure: Amount of time (in weeks) to complete the intervention
timeFrame: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.
measure: Intervention Acceptability
timeFrame: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
measure: Participant Satisfaction
timeFrame: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
measure: Working Alliance Inventory after First Intervention Session
timeFrame: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).
measure: Working Alliance Inventory after Sixth Intervention Session
timeFrame: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).
measure: Working Alliance Inventory after Final Intervention Session
timeFrame: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
Secondary outcomes:
measure: Family Impact During a Pandemic at Baseline
timeFrame: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).
measure: Family Impact During a Pandemic after Final Intervention Session
timeFrame: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).
measure: Efficacy of Virtual-Care CBT Intervention
timeFrame: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).
measure: Clinician Virtual Care Experience
timeFrame: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children (SickKids)
name: Suneeta Monga, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: World Health Organization. Health Equity. Geneva; 2017.
citation: Ontario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.
citation: Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2016;45(2):91-113. doi: 10.1080/15374416.2015.1046177. Epub 2015 Jun 18.
citation: Seligman LD, Ollendick TH. Cognitive-behavioral therapy for anxiety disorders in youth. Child Adolesc Psychiatr Clin N Am. 2011 Apr;20(2):217-38. doi: 10.1016/j.chc.2011.01.003.
citation: Carpenter AL, Pincus DB, Furr JM, Comer JS. Working From Home: An Initial Pilot Examination of Videoconferencing-Based Cognitive Behavioral Therapy for Anxious Youth Delivered to the Home Setting. Behav Ther. 2018 Nov;49(6):917-930. doi: 10.1016/j.beth.2018.01.007. Epub 2018 Mar 5.
citation: Slone NC, Reese RJ, McClellan MJ. Telepsychology outcome research with children and adolescents: a review of the literature. Psychol Serv. 2012 Aug;9(3):272-292. doi: 10.1037/a0027607.
citation: Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
citation: Tracey T, Kokotovic A. Factor structure of the Working Alliance Inventory. Psychological Assessmen. Psychol Assess. 1989;1(3):207-210. doi:10.1037/1040-3590.1.3.207
citation: Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.