NCT04686864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

December 15, 2020

Last Update Submit

September 6, 2022

Conditions

Keywords

eating disorderparent support group

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in Carer Burden

    Baseline, 3 months, 6 months

  • Change in Carer Needs

    Baseline, 3 months, 6 months

  • Change in Parental Self Efficacy and Collaboration

    Baseline, 3 months, 6 months

Study Arms (1)

Parent Support Group

EXPERIMENTAL

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

Behavioral: Support Group for Caregivers

Interventions

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.

Parent Support Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

Related Publications (2)

  • Nicula M, Grennan L, Loewen T, Crews E, Giuliani K, Webb C, Gouveia MR, Couturier J. Virtual parent-led peer support groups for parents of children with eating disorders: A mixed methods feasibility study. Int J Eat Disord. 2023 Nov;56(11):2107-2119. doi: 10.1002/eat.24042. Epub 2023 Aug 14.

  • Grennan L, Nicula M, Pellegrini D, Giuliani K, Crews E, Webb C, Gouveia MR, Loewen T, Couturier J. "I'm not alone": a qualitative report of experiences among parents of children with eating disorders attending virtual parent-led peer support groups. J Eat Disord. 2022 Dec 15;10(1):195. doi: 10.1186/s40337-022-00719-2.

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Self-Help GroupsCaregivers

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Jennifer Couturier, MD MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: We studied the implementation of a virtual parent-led peer support group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jennifer Couturier

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 29, 2020

Study Start

January 21, 2021

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations