Eating DisordersEarly Phase 1NCT04686864
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
A Early Phase 1 study testing Support Group for Caregivers in people with Eating Disorders, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Support Group for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2021to 21 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Eating Disorders
- Being tested
- Support Group for Caregivers
- Keywords
- eating disorder, parent support group
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support Group for CaregiversBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent Support Group | Experimental | Support and psychoeducation in a group setting for parents who have a child or adolescent with an eating disorder. Receives: Behavioral: Support Group for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 12 months after baseline
Secondary outcomes (3)
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).
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start21 Jan 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We studied the implementation of a virtual parent-led peer support group.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Couturier, McMaster University
- Investigators
- Jennifer Couturier, MD MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686864
- Sponsor's protocol ID
- 12703
- Status last verified
- Sep 2022
- First submitted
- 15 Dec 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37578287Grennan 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686864
- Acronym / sponsor ID
- 12703
- Conditions
- Eating Disorders
- Keywords
- eating disorder, parent support group
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We studied the implementation of a virtual parent-led peer support group.
| Arm | Type | Receives |
|---|---|---|
| Parent Support Group | Experimental | Behavioral: Support Group for CaregiversSupport and psychoeducation in a group setting for parents who have a child or adolescent with an eating disorder. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support Group for CaregiversEngage 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. | Behavioural | Parent Support Group |
Primary outcome
Change in number of parents who remain in the support group
Time frame: Baseline and 6 months later
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
Time frame: 6 months after baseline
We will take note of how many support groups the parent attends in a 6 month period.
Cost
Time frame: 12 months after baseline
To assess cost, we will collect data on the costs of the technology, software, and time (of parents and the facilitator).
3 secondary outcomes
Change in Carer Burden
Time frame: Baseline, 3 months, 6 months
Change in Carer Needs
Time frame: Baseline, 3 months, 6 months
Change in Parental Self Efficacy and Collaboration
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Derived from this study: PubMed 37578287Nicula 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.
- Derived from this study: PubMed 36522772Grennan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Couturier, MD MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Support Group for Caregivers in people with Eating Disorders, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of parents who remain in the support group (time frame: Baseline and 6 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.