Integrated Care Pathway for Youth Depression

NCT03428555 | Unknown

• 1 other identifier: 079/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in Childhood Depression Rating Scale-Revised scores

  The CDRS-R is a 17-item measure rated by an evaluator after a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. Scores range from 0 to 100 with a score of over 55 interpreted as a moderate to severe rating. Lower values represent a better outcome.

  20 weeks

Secondary Outcomes (2)

• Change in WHO Disability Assessment Schedule 2.0 for Children And Youth

  20 weeks

• Change in Childhood Behaviour Checklist

  20 weeks

Study Arms (2)

Integrate Care Pathway

EXPERIMENTAL

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).

Behavioral: Integrated Care Pathway

Treatment As Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment As Usual

Interventions

Integrated Care Pathway BEHAVIORAL

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

Integrate Care Pathway

Treatment As Usual BEHAVIORAL

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.

Treatment As Usual

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Psychiatrist's impression is that depression is a primary psychiatric. concern
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y 3M5, Canada

NOT YET RECRUITING

The Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Publications (1)

• Courtney DB, Cheung A, Henderson J, Bennett K, Wang W, Chen S, Battaglia M, Strauss J, Mitchell R, Wang K, Relihan J, Prebeg M, Darnay K, Szatmari P. CARIBOU-1: A pilot controlled trial of an Integrated Care Pathway for the treatment of depression in adolescents. JCPP Adv. 2022 May 27;2(2):e12083. doi: 10.1002/jcv2.12083. eCollection 2022 Jun.

  PMID: 37431464 DERIVED

MeSH Terms

Conditions

Depression; Adolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Peter Szatmari, MD

  The Center for Addiction and Mental Health

  STUDY DIRECTOR

Central Study Contacts

Darren B Courtney, MD

CONTACT

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

Michelle Li, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Intervention Arm (n=30 over 17 months at, CAMH): The intervention is an integrated care pathway and Comparison Arm- Treatment As Usual (n=30 over 17 months at SHSC):

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: March 29, 2018
• Primary Completion: August 29, 2019
• Study Completion: February 21, 2020
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

CA (2)