NCT03527914

Brief Summary

Researchers believe that clinical care can be improved by engaging patients and families directly in planning the care process. Engagement efforts have included asking patients/families to provide information about whether they are getting better. But what does "getting better" mean? The merits of surveys, questionnaires, or rating scales have been widely discussed. Should they be disorder-specific or global? What should the investigators do if patients have difficulty reading or understanding these instruments? Investigators in the United Kingdom have proposed a simple solution: ask the patients and families what their primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes or GBO). Although there has been some work to suggest that this is helpful, it has never been tested in a controlled way. This study will do a randomized controlled trial to test whether GBO improves clinical care in child and youth mental health. Although the study will use this in child and youth mental health care, if it is successful, it can be tested and applied in any care setting with any type of medical problem. This could change practice at the Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

February 18, 2018

Last Update Submit

March 9, 2023

Conditions

Keywords

DepressionPsychosisPersonality DisorderSubstance Abuse

Outcome Measures

Primary Outcomes (3)

  • Patient/Family Satisfaction

    Measured using the Experience of Service Questionnaire

    Administered at study completion (up to 52 weeks)

  • Change in Symptoms

    Measured using the Strengths and Difficulties Questionnaire (SDQ)

    Administered at the first appointment and at study completion (up to 52 weeks)

  • Change in Function

    Measured using the Child Global Assessment of Functioning Scale. The total score (on a scale of 0-100) will be used, with a higher score indicating better function

    Administered at the first appointment and at study completion (up to 52 weeks)

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Patients will receive their standard care at the Outpatient Mental Health Service

Other: Treatment as Usual

Goal Based Outcomes

EXPERIMENTAL

Up to three goals can be tracked during treatment, although patients often decide to just focus on one. Progress on the goal is then quantitatively rated by the patient, with the provider, at every appointment. Adjustments in the care are then made in an iterative process to ensure that the goal will be met.

Other: Goal Based Outcomes

Interventions

Up to three goals can be tracked during treatment, although patients often decide to just focus on one. Progress on the goal is then quantitatively rated by the patient, with the provider, at every appointment. Adjustments in the care are then made in an iterative process to ensure that the goal will be met.

Goal Based Outcomes

Patients will receive their standard care at the Outpatient Mental Health Service

Treatment as Usual

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and youth
  • Attending outpatient mental health services at CHEO

You may not qualify if:

  • Child and youth attending group therapy at CHEO Outpatient Mental Health Services

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

Psychological Well-BeingDepressionPsychotic DisordersPersonality DisordersSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Kathleen Pajer, MD

    Children's Hospital of Eastern Ontario

    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
Chief of Psychiatry

Study Record Dates

First Submitted

February 18, 2018

First Posted

May 17, 2018

Study Start

November 15, 2018

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations