NCT01051375

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration 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

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

January 15, 2010

Last Update Submit

May 10, 2016

Conditions

Keywords

anorexia nervosabulimia nervosaEDNOS

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    12 months

Study Arms (2)

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.

Behavioral: Psychoeducational Workshop and telephone support

Standard of Care

NO INTERVENTION

These patients continue to receive the standard of care while awaiting formal assessment.

Interventions

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.

Waitlist Group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • medical stability at time of referral
  • completed referral to the Eating Disorders Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark Norris, MD

    CHEO

    PRINCIPAL INVESTIGATOR
  • Wendy Spettigue, MD

    CHEO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations