Anxiety Disorder of Childhood or AdolescenceNCT04408027
Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
A study testing Virtual-Care Cognitive Behavioural Therapy in people with Anxiety Disorder of Childhood or Adolescence, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Anxiety Disorder of Childhood or Adolescence
- What is being tested?
- Virtual-Care Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G1X8
About this study
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.
Read the 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.
- Being tested
- Virtual-Care Cognitive Behavioural Therapy
- Keywords
- anxiety disorder, child, adolescent, virtual-care, cognitive behavioural therapy, COVID-19, mental health
- Medical subject headings
- Anxiety Disorders, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-Care Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual-Care Cognitive Behavioural Therapy | Experimental | Not described Receives: Behavioral: Virtual-Care Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Barriers
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).
Measured: 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).
Number of Eligible Participants
Number of participants that were eligible for the study.
Measured: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.
Number of Participants Approached
Number of participants that were approached for the study.
Measured: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.
Number of Participants Consented
Number of participants consented for the study.
Measured: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.
Rates of Refusal
Rates of refusal for participation in the study.
Measured: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
Reasons for Refusal
Reasons for refusal for participation in the study.
Measured: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
Number of Sessions Completed in Total
The average number of sessions completed in total will be captured to evaluate intervention adherence.
Measured: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.
Adherence Index
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.
Measured: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.
Amount of time (in weeks) to complete the intervention
The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.
Measured: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.
Intervention Acceptability
The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Measured: 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).
Participant Satisfaction
The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
Measured: 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).
Working Alliance Inventory after First Intervention Session
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
Measured: 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).
Working Alliance Inventory after Sixth Intervention Session
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
Measured: 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).
Working Alliance Inventory after Final Intervention Session
The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy \& Kokotovic, 1989).
Measured: 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 (4)
Family Impact During a Pandemic at Baseline
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.
Measured: 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).
Family Impact During a Pandemic after Final Intervention Session
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.
Measured: 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).
Efficacy of Virtual-Care CBT Intervention
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.
Measured: 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).
Clinician Virtual Care Experience
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.
Measured: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorder of Childhood or AdolescenceStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suneeta Monga, The Hospital for Sick Children
- Investigators
- Suneeta Monga, MD, FRCPC, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408027
- Sponsor's protocol ID
- REB1000070362
- Status last verified
- Oct 2022
- First submitted
- 26 May 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. Health Equity. Geneva; 2017.
Ontario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.
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.
PubMed 26087438Seligman 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.
PubMed 21440852Carpenter 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.
PubMed 30316490Slone 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.
PubMed 22867120Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PubMed 18183564Tracey 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
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.
PubMed 9100430
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions
- ClinicalTrials.gov ID
- NCT04408027
- Acronym / sponsor ID
- REB1000070362
- Keywords
- anxiety disorder, child, adolescent, virtual-care, cognitive behavioural therapy, COVID-19, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual-Care Cognitive Behavioural Therapy | Experimental | Behavioral: Virtual-Care Cognitive Behavioural Therapy |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual-Care Cognitive Behavioural TherapyThe 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. | Behavioural | Virtual-Care Cognitive Behavioural Therapy |
Primary outcome
Participation Barriers
Time frame: 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
Time frame: 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.
Number of Participants Approached
Time frame: 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.
Number of Participants Consented
Time frame: 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.
Rates of Refusal
Time frame: 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.
Reasons for Refusal
Time frame: 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.
Number of Sessions Completed in Total
Time frame: 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
Time frame: 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.
Amount of time (in weeks) to complete the intervention
Time frame: 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.
Intervention Acceptability
Time frame: 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).
Participant Satisfaction
Time frame: 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).
Working Alliance Inventory after First Intervention Session
Time frame: 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).
Working Alliance Inventory after Sixth Intervention Session
Time frame: 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).
Working Alliance Inventory after Final Intervention Session
Time frame: 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).
4 secondary outcomes
Family Impact During a Pandemic at Baseline
Time frame: 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).
Family Impact During a Pandemic after Final Intervention Session
Time frame: 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).
Efficacy of Virtual-Care CBT Intervention
Time frame: 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).
Clinician Virtual Care Experience
Time frame: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- BackgroundWorld Health Organization. Health Equity. Geneva; 2017.
- BackgroundOntario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.
- Background: PubMed 26087438Higa-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.
- Background: PubMed 21440852Seligman 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.
- Background: PubMed 30316490Carpenter 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.
- Background: PubMed 22867120Slone 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.
- Background: PubMed 18183564Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- BackgroundTracey 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
- Background: PubMed 9100430Birmaher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneeta Monga, MD, FRCPC principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual-Care Cognitive Behavioural Therapy in people with Anxiety Disorder of Childhood or Adolescence, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Barriers (time frame: 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).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408027, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.