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CompletedNCT04686864Updated Sep 10, 2022

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

An Early Phase 1 interventional study of Support Group for Caregivers in Eating Disorders, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-10.

Sponsored by McMaster University · Early Phase 1, Interventional, and Supportive care

Phase
Early Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Eating Disorders

Keywords

  • eating disorder
  • parent support group
03

In context

Feeding and Eating Disorders

753 studies on the registry are indexed under Feeding and Eating Disorders; 160 are open to participants now.

This study's enrollment of 36 is below the median of 74 across 551 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Parent Support Group

    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

  • BehavioralSupport 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 months later

  2. Number of support groups each parent attends

    We will take note of how many support groups the parent attends in a 6 month period.

    Time frame: 6 months after baseline

  3. Cost

    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 outcomes

  1. 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).

    Time frame: Baseline, 3 months, 6 months

  2. 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.

    Time frame: Baseline, 3 months, 6 months

  3. 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.

    Time frame: Baseline, 3 months, 6 months

07

Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8N3Z5, Canada
08

References and documents

Publications

  • 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. PubMed 37578287 ↗
  • 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. PubMed 36522772 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Jan 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2020
First posted
Dec 29, 2020
StartActual
Jan 21, 2021
Primary completionActual
Jan 21, 2022
CompletionActual
Jan 21, 2022
Last update
Sep 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04686864
Responsible party
Jennifer Couturier (Dr. Jennifer Couturier, McMaster University) — Principal investigator
First posted
Dec 29, 2020
Start date
Jan 21, 2021
Primary completion
Jan 21, 2022
Completion
Jan 21, 2022
Last update
Sep 10, 2022

Study contacts

Jennifer Couturier, MD MSc
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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