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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04686864
Other study ID # 12703
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date January 21, 2021
Est. completion date January 21, 2022

Study information

Verified date September 2022
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 21, 2022
Est. primary completion date January 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Support Group for Caregivers
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.

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 6 months later
Primary Number of support groups each parent attends We will take note of how many support groups the parent attends in a 6 month period. 6 months after baseline
Primary Cost To assess cost, we will collect data on the costs of the technology, software, and time (of parents and the facilitator). 12 months after baseline
Secondary 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). Baseline, 3 months, 6 months
Secondary 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. Baseline, 3 months, 6 months
Secondary 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. Baseline, 3 months, 6 months
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