Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorCentre for Addiction and Mental Health

About this trial

This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Youth is aged 13 to 18 years, inclusive.

Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.

Clinician agrees that depressive symptoms are a treatment target.

Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).

Disqualifiers

Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.

Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.

Inability to provide informed consent to the study for any reason

Youth currently in Day Treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • Treatment As Usual

    Other intervention

    Various typical interventions for adolescents with depression.

  • CARIBOU-2

    Other intervention

    Integrated Care Pathway intervention for adolescents with depression.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Treatment as UsualActive comparator 1 intervention
Group B: CARIBOU-2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Mood and Feelings Questionnaire (MFQ) child, long version

The MFQ is a 33-item self-report measure for youth regarding depressive symptoms experienced over the prior 2 weeks. It was specifically recommended in the NICE guideline, given its strong psychometric properties; namely, it has high discriminatory ability in adolescents, good internal consistency (α=0.92-0.94) and good test-retest reliability (Pearson's r=0.78). It has also been used in a large trial of psychotherapy with adolescents where it was sensitive to change.

Time frame
Change from baseline to 24 weeks

Secondary outcomes

1

The Child Behaviour Checklist (CBCL) - Parent Report Form

A 118-item caregiver-rated measure assessing the youth's behaviour and general psychopathology. It is a widely used measure with known population norms. One-week test-retest reliability was found to be 0.80-0.94. Internal consistency is reported to be high; inter-rater reliability (e.g., between two parents) was found to be moderate to high (reference needed). All subscales will be used at baseline to describe general psychopathology. The internalizing broadband scale of the CBCL (i.e. anxious-depressed, depressed-withdrawn, and somatic subscales combined) will be measured longitudinally to get an impression of how the caregiver is observing any changes in mood or anxiety with treatment.

Time frame
Baseline to 24-weeks
2

Columbia Suicide Severity Rating Scale

This measure contains items related self-injurious thoughts and behaviours. RAs rate 3 subscales: Suicidal Ideation Severity, Suicidal Behaviour (which includes suicide attempts and an item for non-suicidal self-injury that is recorded as distinct from suicidal behaviour), and Lethality.

Time frame
Change from baseline to 24 weeks
3

Depression Rating Scale

This is an RA-rated 13-item subscale found in the Kiddie Schedule for Affective Disorders and Schizophrenia-Lifetime version used to assess for DSM-5 criteria of Major Depressive Disorder.

Time frame
Change from baseline to 24 weeks
4

Youth Quality of Life Scale Research Version

This is a 41 item self-report scale measuring the broad array of constructs including sense of self-worth, quality of relationships, sense of agency and life satisfaction.

Time frame
Change from baseline to 24 weeks

Other outcomes

Sponsors and contacts

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Centre for Addiction and Mental Health

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

The Hospital for Sick Children

Collaborator