search
Back to results

A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes

Primary Purpose

Eating Disorders

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Support Group for Caregivers
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eating Disorders focused on measuring eating disorder, parent support group

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • have the capacity to write, speak and understand English, in order to participate in the sessions
  • have access to the internet/computer to participate in the sessions
  • must have a child or adolescent with an eating disorder.

Exclusion Criteria:

  • don't have the capacity to write, speak and understand English
  • don't have access to the internet/computer
  • don't have a child or adolescent with an eating disorder

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parent Support Group

Arm Description

Support and psychoeducation in a group setting for parents who have a child or adolescent with an eating disorder.

Outcomes

Primary Outcome Measures

Change in number of parents who remain in the support group
We will compare the number of parents who initially sign up for the support group to how many parents have stayed in the support group 6 months later.
Number of support groups each parent attends
We will take note of how many support groups the parent attends in a 6 month period.
Cost
To assess cost, we will collect data on the costs of the technology, software, and time (of parents and the facilitator).

Secondary Outcome Measures

Change in Carer Burden
Carer 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 Carer Needs
Carer 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 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.

Full Information

First Posted
December 15, 2020
Last Updated
September 6, 2022
Sponsor
McMaster University
search

1. Study Identification

Unique Protocol Identification Number
NCT04686864
Brief Title
A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes
Official Title
A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 21, 2022 (Actual)

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
There is a gap in the literature about the feasibility and implementation of parent-led support groups for parents who have children or adolescents with eating disorders. In this study, we will be observing the experiences of 40 parents in Ontario who will virtually participate in one of 3 parent-led support groups for parents of children and youth with eating disorders. Parents will be expected to attend the virtual sessions twice a month over the course of six months. We hope to evaluate the acceptability, cost, and parental outcomes of the parent-led support groups via surveys before, during, and after the study, as well as using a post-study interview.

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
We studied the implementation of a virtual parent-led peer support group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Support Group
Arm Type
Experimental
Arm Description
Support and psychoeducation in a 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
Change in number of parents who remain in the support group
Description
We will compare the number of parents who initially sign up for the support group to how many parents have stayed in the support group 6 months later.
Time Frame
Baseline and 6 months later
Title
Number of support groups each parent attends
Description
We will take note of how many support groups the parent attends in a 6 month period.
Time Frame
6 months after baseline
Title
Cost
Description
To assess cost, we will collect data on the costs of the technology, software, and time (of parents and the facilitator).
Time Frame
12 months after baseline
Secondary Outcome Measure Information:
Title
Change in Carer Burden
Description
Carer 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, 3 months, 6 months
Title
Change in Carer Needs
Description
Carer 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, 3 months, 6 months
Title
Change in 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, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: have the capacity to write, speak and understand English, in order to participate in the sessions have access to the internet/computer to participate in the sessions must have a child or adolescent with an eating disorder. Exclusion Criteria: don't have the capacity to write, speak and understand English don't have access to the internet/computer don't have a child or adolescent with an eating disorder
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
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Virtual Parent-led Support Group for Parents of Children and Youth With Eating Disorders: A Mixed Methods Feasibility Study Examining Acceptability, Cost and Parent Outcomes

We'll reach out to this number within 24 hrs