Implementing Virtual Parent Support Groups for Eating Disorders Across Canada (vPLPSG)
Primary Purpose
Eating Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Support Group for Caregivers
Sponsored by
About this trial
This is an interventional health services research trial for Eating Disorders focused on measuring eating disorder, parent support group, COVID-19
Eligibility Criteria
Inclusion Criteria:
- Have the capacity to write, speak and understand English
- Have access to a computer and internet
- Among parents enrolled in the virtual parent-led peer support groups, they must have a child or adolescent (<18 years of age) diagnosed with an eating disorder
- Among youth and parents of youth with an eating disorder in the qualitative interviews component of the study, they/their child must either be on a waiting list for eating disorder treatment, actively in treatment, or post-treatment; the youth must be <18 years of age and the parent must have a child <18 years of age
- Among clinician/administrators in the qualitative interviews component of the study, they must work within pediatric eating disorder programs or lifespan eating disorder programs.
Exclusion Criteria:
- No lived or professional experience in the field of eating disorders
- Don't have the capacity to write, speak and understand English
- Don't have access to the internet/computer
Sites / Locations
- University of CalgaryRecruiting
- IWK Health CentreRecruiting
- McMaster UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stakeholder Perspectives and Virtual Parent-Led Peer Support Group
Arm Description
Qualitative interviews regarding the impact of COVID-19 will be conducted with youth who have an eating disorder (ED), parents of youth who have an ED, ED clinicians and ED program administrators, as well as get their perspectives on parent-led peer support groups. Three parent-led peer support groups will be started, including psychoeducation in a virtual group setting for parents who have a child or adolescent with an eating disorder.
Outcomes
Primary Outcome Measures
Parent, youth, clinician, and administrator perspectives on and experiences with the COVID-19 pandemic and children, youth, and families with eating disorders
Perspectives and experiences qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Parent, youth, clinician, and administrator perspectives on virtual parent-led peer support groups to help mitigate the negative effects of COVID-19 on children, youth, and families with eating disorders across Canada
Perspectives qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Parent, youth, clinician, and administrator perspectives on factors important for implementing and sustaining virtual parent-led peer support groups
Perspectives qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Secondary Outcome Measures
Change in number of parents who remain in the support group (Retention Rate)
The investigators will compare the number of parents who consent to participate in the support group and study to the number of parents who have completed the support group and study, 3 months later.
Number of support groups each parent attends (Attendance Rate)
The investigators will take note of how many support groups (out of 6) each parent attends in a 3 month period.
Change in self-reported parental burden
Parental burden will be assessed using the Eating Disorders Symptom Impact Scale (EDSIS) - a 24 item measure examining the impact of symptoms on parents' lives. Minimum score is 0, maximum score is 96. A higher score indicates that the child's eating disorder symptoms are having a greater impact on their parent (more burdensome).
Change in self-reported needs as a parent of a child with an eating disorder
Parental needs will be assessed using the Carers Needs Assessment Measure (CaNAM), a 47-item questionnaire examining information received about eating disorders, support received from other people and organizations, support for self, and areas where help is needed. The minimum score is 0, the maximum score is 64. A higher score indicates that the carer has received sufficient information and support for themselves and their child.
Change in self-reported parental self efficacy and collaboration
Parental self-efficacy and collaboration will be assessed using the Patient and Carer Collaboration Scale -C (PACCS), a 33-item questionnaire examining constructs such as hope, self-care and compassion, externalization of the eating disorder, and boundaries. Each question is evaluated on a scale of 0 to 100, where higher values indicate positive collaboration with their child and higher parental self efficacy.
Parent Peer Support Providers' Change in Readiness
The Brief Individual Readiness to Change Scale will indicate how ready parent peer support providers feel they are to change. Higher scores indicate greater readiness to use research-based direct service techniques. Minimum score is 0, maximum score is 20.
Parent Peer Support Providers' Change in Attitudes about Evidence Based Practice
Their attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS). The subscales include requirements, appeal, openness and divergence. The score for each subscale is created by computing a mean score for the items that load on a given subscale. Minimum score for each subscale is 0, maximum score for each subscale is 4.
Parent Peer Support Providers' Change in Confidence related to the Intervention
Their confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAS). Higher scores are indicative of more favorable perception for virtual parent led peer support group content. The minimum score is 18, the maximum score is 90.
Parent Peer Support Providers' Self-Reported Fidelity to Peer Support
Parent peer support providers leading the virtual parent-led peer support groups will complete a self-reported measure related to rating their fidelity to peer support, outlining their adherence to peer support principles. The minimum score is 14, the maximum score is 70.
Full Information
NCT ID
NCT05151900
First Posted
October 29, 2021
Last Updated
September 6, 2022
Sponsor
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT05151900
Brief Title
Implementing Virtual Parent Support Groups for Eating Disorders Across Canada
Acronym
vPLPSG
Official Title
Understanding and Mitigating the Impact of the COVID-19 Pandemic on Children, Youth, and Families Living With an Eating Disorder: A National Implementation Study of a Virtual Parent-Led Peer Support Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
During the COVID-19 pandemic, Canada has experienced a surge in new pediatric eating disorder cases and hospitalizations and long treatment waitlists, with parents experiencing anxiety due to a lack of support. As it has not been rigorously studied, there is an urgent need to understand and mitigate the impact of the COVID-19 pandemic on children, youth, and families living with eating disorders across Canada. The investigator's proposed research has two goals. First, the investigators plan to understand the impact of the COVID-19 pandemic faced by this population throughout the country, as well as describe stakeholder views on virtual parent-led peer support groups. Given the increased burden faced by parents of children with eating disorders during the COVID-19 pandemic, the second goal is to study whether the national implementation of virtual parent-led peer support groups helps to mitigate the impact of the pandemic among affected parents. The investigators will use qualitative semi-structured interviews to gather an understanding of the impact of the pandemic on relevant stakeholders across the country. At the same time, the investigators will evaluate the feasibility and acceptability of the implementation of virtual parent-led peer support groups in several regions of Canada by examining parent and parent peer support provider experiences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
eating disorder, parent support group, COVID-19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stakeholder Perspectives and Virtual Parent-Led Peer Support Group
Arm Type
Experimental
Arm Description
Qualitative interviews regarding the impact of COVID-19 will be conducted with youth who have an eating disorder (ED), parents of youth who have an ED, ED clinicians and ED program administrators, as well as get their perspectives on parent-led peer support groups. Three parent-led peer support groups will be started, including psychoeducation in a virtual group setting for parents who have a child or adolescent with an eating disorder.
Intervention Type
Behavioral
Intervention Name(s)
Support Group for Caregivers
Intervention Description
Engage parents in the community via this support group, so they can be supported by other parents who "know the system", can advise them on how to proceed, and empower them to help their children. Parents will learn psychoeducation about eating disorders and how to support their children.
Primary Outcome Measure Information:
Title
Parent, youth, clinician, and administrator perspectives on and experiences with the COVID-19 pandemic and children, youth, and families with eating disorders
Description
Perspectives and experiences qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Time Frame
Baseline to 6 months later
Title
Parent, youth, clinician, and administrator perspectives on virtual parent-led peer support groups to help mitigate the negative effects of COVID-19 on children, youth, and families with eating disorders across Canada
Description
Perspectives qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Time Frame
Baseline to 6 months later
Title
Parent, youth, clinician, and administrator perspectives on factors important for implementing and sustaining virtual parent-led peer support groups
Description
Perspectives qualitatively measured by semi-structured individual interviews with participants with lived experience or expertise in pediatric eating disorders during the COVID-19 pandemic.
Time Frame
Baseline to 6 months later
Secondary Outcome Measure Information:
Title
Change in number of parents who remain in the support group (Retention Rate)
Description
The investigators will compare the number of parents who consent to participate in the support group and study to the number of parents who have completed the support group and study, 3 months later.
Time Frame
Baseline and 3 months later
Title
Number of support groups each parent attends (Attendance Rate)
Description
The investigators will take note of how many support groups (out of 6) each parent attends in a 3 month period.
Time Frame
3 months after baseline
Title
Change in self-reported parental burden
Description
Parental burden will be assessed using the Eating Disorders Symptom Impact Scale (EDSIS) - a 24 item measure examining the impact of symptoms on parents' lives. Minimum score is 0, maximum score is 96. A higher score indicates that the child's eating disorder symptoms are having a greater impact on their parent (more burdensome).
Time Frame
Baseline and 3 months later
Title
Change in self-reported needs as a parent of a child with an eating disorder
Description
Parental needs will be assessed using the Carers Needs Assessment Measure (CaNAM), a 47-item questionnaire examining information received about eating disorders, support received from other people and organizations, support for self, and areas where help is needed. The minimum score is 0, the maximum score is 64. A higher score indicates that the carer has received sufficient information and support for themselves and their child.
Time Frame
Baseline and 3 months later
Title
Change in self-reported parental self efficacy and collaboration
Description
Parental self-efficacy and collaboration will be assessed using the Patient and Carer Collaboration Scale -C (PACCS), a 33-item questionnaire examining constructs such as hope, self-care and compassion, externalization of the eating disorder, and boundaries. Each question is evaluated on a scale of 0 to 100, where higher values indicate positive collaboration with their child and higher parental self efficacy.
Time Frame
Baseline and 3 months later
Title
Parent Peer Support Providers' Change in Readiness
Description
The Brief Individual Readiness to Change Scale will indicate how ready parent peer support providers feel they are to change. Higher scores indicate greater readiness to use research-based direct service techniques. Minimum score is 0, maximum score is 20.
Time Frame
Baseline and 6 months later
Title
Parent Peer Support Providers' Change in Attitudes about Evidence Based Practice
Description
Their attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS). The subscales include requirements, appeal, openness and divergence. The score for each subscale is created by computing a mean score for the items that load on a given subscale. Minimum score for each subscale is 0, maximum score for each subscale is 4.
Time Frame
Baseline and 6 months later
Title
Parent Peer Support Providers' Change in Confidence related to the Intervention
Description
Their confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAS). Higher scores are indicative of more favorable perception for virtual parent led peer support group content. The minimum score is 18, the maximum score is 90.
Time Frame
Baseline and 6 months later
Title
Parent Peer Support Providers' Self-Reported Fidelity to Peer Support
Description
Parent peer support providers leading the virtual parent-led peer support groups will complete a self-reported measure related to rating their fidelity to peer support, outlining their adherence to peer support principles. The minimum score is 14, the maximum score is 70.
Time Frame
Baseline and 6 months later
Other Pre-specified Outcome Measures:
Title
Parent participant experiences
Description
Virtual parent-led peer support group experiences of parents participants, qualitatively measured by semi-structured individual interviews with parents after 3 months in virtual parent-led peer support groups.
Time Frame
After 3 months in groups
Title
Parent Peer Support Provider experiences
Description
Virtual parent-led peer support group experiences of parent peer support providers, qualitatively measured by semi-structured focus group with virtual parent-led peer support groups and a focus group with parent peer support providers after 6 months of leading groups.
Time Frame
After 6 months leading groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have the capacity to write, speak and understand English
Have access to a computer and internet
Among parents enrolled in the virtual parent-led peer support groups, they must have a child or adolescent (<18 years of age) diagnosed with an eating disorder
Among youth and parents of youth with an eating disorder in the qualitative interviews component of the study, they/their child must either be on a waiting list for eating disorder treatment, actively in treatment, or post-treatment; the youth must be <18 years of age and the parent must have a child <18 years of age
Among clinician/administrators in the qualitative interviews component of the study, they must work within pediatric eating disorder programs or lifespan eating disorder programs.
Exclusion Criteria:
No lived or professional experience in the field of eating disorders
Don't have the capacity to write, speak and understand English
Don't have access to the internet/computer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Pellegrini, BSc, MPH
Phone
289-880-4149
Email
pellegdm@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Couturier, MD MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Dimitropoulos, MSW, PhD
Email
gdimit@ucalgary.ca
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Wozney, MA, PhD
Email
lori.wozney@nshealth.ca
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Couturier, MD MSc
Email
coutur@mcmaster.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Implementing Virtual Parent Support Groups for Eating Disorders Across Canada
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