Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Participants Consented
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Number of Participants Consented
时间窗: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.
Number of participants consented for the study.
Intervention Acceptability
时间窗: 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).
The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Working Alliance Inventory after Sixth Intervention Session
时间窗: 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).
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
Participation Barriers
时间窗: 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).
Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).
Number of Eligible Participants
时间窗: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.
Number of participants that were eligible for the study.
Reasons for Refusal
时间窗: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
Reasons for refusal for participation in the study.
Working Alliance Inventory after Final Intervention Session
时间窗: 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).
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
Number of Participants Approached
时间窗: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.
Number of participants that were approached for the study.
Rates of Refusal
时间窗: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
Rates of refusal for participation in the study.
Amount of time (in weeks) to complete the intervention
时间窗: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.
The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.
Participant Satisfaction
时间窗: 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).
The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Number of Sessions Completed in Total
时间窗: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.
The average number of sessions completed in total will be captured to evaluate intervention adherence.
Adherence Index
时间窗: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.
The adherence index (calculated using the formula: sessions completed/total sessions scheduled \[sum of sessions attended, rescheduled, no-showed and cancelled\]) will be used to evaluate intervention adherence.
Working Alliance Inventory after First Intervention Session
时间窗: 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).
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
次要结局
- Efficacy of Virtual-Care CBT Intervention(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).)
- Family Impact During a Pandemic at Baseline(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).)
- Clinician Virtual Care Experience(The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.)
- Family Impact During a Pandemic after Final Intervention Session(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).)
研究者
Suneeta Monga
Associate Psychiatrist-In-Chief
The Hospital for Sick Children