NCT04812899

Brief Summary

The COVID-19 pandemic has resulted in several challenges in service delivery for the eating disorders program at McMaster Children's Hospital. Long waiting lists prior to the pandemic (6-9 month wait time) have been made worse by an interruption in service during the initial stages of the pandemic. New routine assessments were placed on hold for many months, while only the most urgently ill children were seen. This, in combination with a dramatic increase in new referrals has resulted in a long waitlist. Now families are waiting 12-18 months for service. The resulting waitlist is now unmanageable and unsafe. Investigators wish to study the implementation of a waitlist intervention which will educate parents on how to start to renourish their children and interrupt eating disordered behaviors. The intervention will consist of a series of educational videos and a book on how to help their children. It is hoped that this intervention can lessen the need for hospitalization and can change the trajectory of symptoms while waiting for service. A clinical care pathway will also be developed to ensure those waiting receive the most appropriate treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

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

March 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 18, 2021

Last Update Submit

March 28, 2022

Conditions

Keywords

eating disorderswaitlist interventionpandemicchildrenclinical care pathway

Outcome Measures

Primary Outcomes (5)

  • Weight trajectory

    Change in weight trajectory will be measured over the time period of 14 weeks, starting from the Baseline till the end of the study at 14 weeks

    Weight will be collected weekly (in kgs) for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)

  • Binge/purge episodes trajectory

    Change in trajectory of symptoms (number of binge/purge episodes) will be measured pre and post intervention.

    Number of binge/purge episodes will be collected weekly for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)

  • Length of wait time

    Average length of wait time pre and post implementation will be determined by examining wait time in the month prior to implementation for new referrals, compared to the average wait time for new referrals in the month following the completion of the study period

    At 14 weeks

  • Change in number of parents who accepted to participate in the study

    In terms of recruitment, the investigators will examine the number of parents agree to participate versus the number of families invited to the study.

    Baseline and at 14 weeks

  • Change in number of parents who remain in the study

    In terms of retention, the investigators will compare the number of parents completed the study to the number of parents enrolled.

    Baseline and at 14 weeks

Secondary Outcomes (5)

  • Change in Eating Disorder Questionnaire -parent version

    Baseline and at 14 weeks

  • Change in Parent Versus Eating Disorder Scale

    Baseline and at 14 weeks

  • Change in Nine Item Avoidant/Restrictive Food Intake disorder screen

    Baseline and at 14 weeks

  • Change in Pediatric Symptom Checklist-17

    Baseline and at 14 weeks

  • Change in Carers Needs Assessment Measure

    Baseline and at 14 weeks

Study Arms (1)

Parents who have a child/adolescent with an eating disorder on waitlist

EXPERIMENTAL

Each participant will receive a series of pre-recorded videos and book -(10 videos of about 10 minutes each, along with the book "Help Your Teenager Beat an Eating Disorder"). This will include content on empowering parents to renourish their child and interrupt binge/purge behaviors.

Behavioral: Parental guided self-help version of FBT-pre-recorded videos and readings from the book

Interventions

Each participant will receive a series of pre-recorded videos of parental guided self help version FBT. There will be10 videos of about 10 minutes each. The videos will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. Readings will be assigned to each participant from the book "Help Your Teenager Beat and Eating Disorder". There will be psychoeducational content on the dangers and medical complications of eating disorders. The readings will also contain content on coping skills for young people including relaxation, mindfulness strategies, and distress tolerance skills.

Parents who have a child/adolescent with an eating disorder on waitlist

Eligibility Criteria

Age7 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of a child or adolescent (6-17 years) with an Eating Disorder.
  • Have an access to the internet/computer.
  • Have an access to a weigh scale in their home environment
  • Have the capacity to write, speak and understand English

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 Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jennifer Couturier, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 24, 2021

Study Start

July 30, 2021

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations