Recruiting

Integrated Care Pathway

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT03428555

Conditions

ICP1

Depression

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Integrated Care Pathway

Treatment As Usual

Study Details

Brief summary:

Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment decisions). We propose a controlled clinical trial comparing ICP to treatment-as-usual (TAU) across two sites.

Conditions

ICP1

Depression

Adolescent Behavior

Study ID

NCT03428555

Start date

Mar 29, 2018

Status verified date

Aug, 2018

Completion date

Feb 21, 2020

Anticipated

Primary completion date

Aug 29, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Psychiatrist's impression is that depression is a primary psychiatric. concern
  • 14-18 years old.
  • DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder as per the Diagnostic Interview for Affective Symptoms for Children (DIAS-C19).
  • Speak, read and write English at a grade 6 level.

Exclusion Criteria:

  • Threshold psychotic symptoms.
  • Bipolar disorder.
  • Moderate-to-severe substance use disorder.
  • Autistic spectrum disorder or intellectual disability.
  • Eating disorder.
  • Suicide-related behaviours requiring acute intervention.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Integrate Care Pathway

The intervention is an Integrated Care Pathway with 3 key components.

1. Clinical Practice Guidelines (CPG) recommendations: The initial template of the treatment protocol was based on the NICE CPGs for Depression in Children and Young People.
2. Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol.
3. Measurement-based care: Feedback measures are taken every four weeks and the results are provided to the clinician, patient and family to inform treatment decisions. The feedback measures are the Mood and Feelings Questionnaire, the Columbia Impairment Scale (CIS) and the General Functioning Domain of the McMaster Family Assessment Device (MFAD).

active comparator: Treatment As Usual

Treatment As Usual : Participants at SHSC will receive treatment at could include a psychiatric evaluation, possible medication management and various types of psychotherapy, including cognitive-behavioural therapy, interpersonal psychotherapy, psychodynamic psychotherapy and family therapy. There is no structured protocol and no systematic Measurement Based Care. A research assistant will record the interventions received in either group via chart review.

Interventions

Integrated Care Pathway

The intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions

Treatment As Usual

Treatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care.

Primary outcome measure

  • Change in Childhood Depression Rating Scale-Revised scores [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Darren B Courtney, MD

416-535-8501darren.courtney@camh.ca

Michelle Li, BA

416-535-8501michelle.li1@camh.ca

Locations

The Center for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Darren B Courtney, MD

416-535-8501darren.courtney@camh.ca

Susan Dickens, MA

416-535-8501susan.dickens@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Aug 9, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2018-08-09.