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Virtual-Care Cognitive Behavioural TherapyWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug427 CCP Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D001008 Anxiety Disorders NIH 0.17

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions

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.

NCT04408027 Anxiety Disorder of Childhood or Adolescence Behavioral: Virtual-Care Cognitive Behavioural Therapy
MeSH:Anxiety Disorders

Primary Outcomes

Description: 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).

Measure: Participation Barriers

Time: 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).

Description: Number of participants that were eligible for the study.

Measure: Number of Eligible Participants

Time: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants that were approached for the study.

Measure: Number of Participants Approached

Time: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants consented for the study.

Measure: Number of Participants Consented

Time: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.

Description: Rates of refusal for participation in the study.

Measure: Rates of Refusal

Time: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: Reasons for refusal for participation in the study.

Measure: Reasons for Refusal

Time: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: The average number of sessions completed in total will be captured to evaluate intervention adherence.

Measure: Number of Sessions Completed in Total

Time: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: 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.

Measure: Adherence Index

Time: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.

Measure: Amount of time (in weeks) to complete the intervention

Time: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Intervention Acceptability

Time: 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).

Description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Participant Satisfaction

Time: 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).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after First Intervention Session

Time: 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).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Sixth Intervention Session

Time: 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).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Final Intervention Session

Time: 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

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic at Baseline

Time: 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).

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic after Final Intervention Session

Time: 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).

Description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.

Measure: Efficacy of Virtual-Care CBT Intervention

Time: 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).

Description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.

Measure: Clinician Virtual Care Experience

Time: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.


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