Eating DisordersNCT01051375
Examining the Effectiveness of a Wait List Intervention for the Management of Adolescent Eating Disorders
A study testing Psychoeducational Workshop and telephone support in people with Eating Disorders, run by University of Ottawa at 1 site in Canada.
Trial summary
The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Psychoeducational Workshop and telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Dec 2012
- Phase
- Interventional
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- medical stability at time of referral
- completed referral to the Eating Disorders Program
Who cannot join
- patients deemed medically unstable are triaged urgently and not eligible for study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course.
Read the detailed description
The Eating Disorder Program at the Children's Hospital of Eastern Ontario (CHEO) offers a continuum of treatment options to child and adolescent patients with eating disorders (EDs). Although our own funding has increased in recent years, so too have the number of referrals, which has resulted in lengthy wait times for therapeutic assessments by our team. The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course. It is well known that early recognition and implementation of treatment as soon as possible after the onset of symptoms is protective in eating disorders and leads to better success rates and recovery (APA Treatment Guidelines for EDs). It is hoped that the outcome of this study will influence the way in which centers look to address the ongoing issue of lengthy wait times in hopes of offering cost-effective interventions that ultimately improve patient outcomes. By offering an added level of support to families whose referral has been initiated, we hope to ease the burden of primary care providers and increase their satisfaction as it relates to patient safety concerns and complex case management.
- Conditions
- Eating Disorders
- Being tested
- Psychoeducational Workshop and telephone support
- Keywords
- anorexia nervosa, bulimia nervosa, EDNOS
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Workshop and telephone supportBehavioural
The intervention involves completion of a single workshop (delivered by a psychiatrist and adolescent health physician), provision of psycho educational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Group | Experimental | The intervention involves completion of a single workshop, provision of psychoeducational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list, within a month of our receiving the referral. Receives: Behavioral: Psychoeducational Workshop and telephone support |
| Standard of Care | No intervention | These patients continue to receive the standard of care while awaiting formal assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate whether a wait list intervention for patients and families who are on a wait list, improves patient presentation at the time of formal assessment, as well as 6-months post-assessment
Measured: 18 months
Secondary outcomes (1)
Evaluate the impact that a wait list intervention group workshop has on caregiver knowledge, stress, and self-efficacy pertaining to eating disorders and their treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Norris, University of Ottawa
- Investigators
- Mark Norris, MD, Principal investigator, CHEOWendy Spettigue, MD, Principal investigator, CHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051375
- Sponsor's protocol ID
- 09/27E
- Status last verified
- May 2016
- First submitted
- 15 Jan 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of a Wait List Intervention for the Management of Adolescent Eating Disorders
- ClinicalTrials.gov ID
- NCT01051375
- Acronym / sponsor ID
- 09/27E
- Conditions
- Eating Disorders
- Keywords
- anorexia nervosa, bulimia nervosa, EDNOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jan 2010 (estimated)
- 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.
The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course.
Detailed description
The Eating Disorder Program at the Children's Hospital of Eastern Ontario (CHEO) offers a continuum of treatment options to child and adolescent patients with eating disorders (EDs). Although our own funding has increased in recent years, so too have the number of referrals, which has resulted in lengthy wait times for therapeutic assessments by our team. The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course. It is well known that early recognition and implementation of treatment as soon as possible after the onset of symptoms is protective in eating disorders and leads to better success rates and recovery (APA Treatment Guidelines for EDs). It is hoped that the outcome of this study will influence the way in which centers look to address the ongoing issue of lengthy wait times in hopes of offering cost-effective interventions that ultimately improve patient outcomes. By offering an added level of support to families whose referral has been initiated, we hope to ease the burden of primary care providers and increase their satisfaction as it relates to patient safety concerns and complex case management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Group | Experimental | Behavioral: Psychoeducational Workshop and telephone supportThe intervention involves completion of a single workshop, provision of psychoeducational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list, within a month of our receiving the referral. |
| Standard of Care | No intervention | –These patients continue to receive the standard of care while awaiting formal assessment. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- medical stability at time of referral
- completed referral to the Eating Disorders Program
Key exclusion criteria (1 listed)
- patients deemed medically unstable are triaged urgently and not eligible for study inclusion
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 |
|---|---|---|
| Psychoeducational Workshop and telephone supportThe intervention involves completion of a single workshop (delivered by a psychiatrist and adolescent health physician), provision of psycho educational materials, and regular telephone support with a specially trained nurse-coordinator to parents of youth on our waiting list. | Behavioural | Waitlist Group |
Primary outcome
Investigate whether a wait list intervention for patients and families who are on a wait list, improves patient presentation at the time of formal assessment, as well as 6-months post-assessment
Time frame: 18 months
1 secondary outcome
Evaluate the impact that a wait list intervention group workshop has on caregiver knowledge, stress, and self-efficacy pertaining to eating disorders and their treatment
Time frame: 12 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 12 May 2016.
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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.
Mark Norris, MD principal investigator
CHEO
Wendy Spettigue, MD principal investigator
CHEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Workshop and telephone support in people with Eating Disorders, run by University of Ottawa 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 2 inclusion and 1 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 12 May 2016. 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.
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?
Investigate whether a wait list intervention for patients and families who are on a wait list, improves patient presentation at the time of formal assessment, as well as 6-months post-assessment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.