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

NCT04408027 | Unknown

• 1 other identifier: REB1000070362
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder of Childhood or Adolescence

Keywords

anxiety disorder; child; adolescent; virtual-care; cognitive behavioural therapy; COVID-19; mental health

Outcome Measures

Primary Outcomes (14)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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

  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

  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

  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

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

Study Arms (1)

Virtual-Care Cognitive Behavioural Therapy

EXPERIMENTAL

Behavioral: Virtual-Care Cognitive Behavioural Therapy

Interventions

Virtual-Care Cognitive Behavioural Therapy BEHAVIORAL

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.

Virtual-Care Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (9)

• World Health Organization. Health Equity. Geneva; 2017.

  BACKGROUND

• Ontario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.

  BACKGROUND

• 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.

  PMID: 26087438 BACKGROUND

• 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.

  PMID: 21440852 BACKGROUND

• 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.

  PMID: 30316490 BACKGROUND

• 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.

  PMID: 22867120 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 9100430 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior

Study Officials

• Suneeta Monga, MD, FRCPC

  The Hospital for Sick Children (SickKids)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Psychiatrist-In-Chief

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)