An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.

Official Title
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An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Conditions
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Depressive Disorder

Intervention / Treatment
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* Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
* Drug: Selective Serotonin Reuptake Inhibitor
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised [CDRS-R] & Beck Depression Inventory-II [BDI-II]) Current impairment in psychosocial functioning (based on Children's Global Assessment Scale [CGAS]) Exclusion Criteria: Non English-speaking Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder. Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study. Currently taking medication for a psychiatric diagnosis other than ADHD Females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an SSRI.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPT-A - possible augment with addl IPT-A<br>Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, the dose of IPT-A will be increased by scheduling sessions twice per week for 4 weeks (16 sessions total). | Behavioral: Interpersonal Psychotherapy for Depressed Adolescents<br>* IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.<br>|
| Experimental: IPT-A - possible augment with SSRI<br>Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, treatment will be augmented by adding a selective serotonin reuptake inhibitor (SSRI). | Behavioral: Interpersonal Psychotherapy for Depressed Adolescents<br>* IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.<br>Drug: Selective Serotonin Reuptake Inhibitor<br>* Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline<br>|
| Active Comparator: Usual Care<br>Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI. | Other: Usual Care<br>* Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depressive symptoms (Children's Depression Rating Scale - Revised) |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Interpersonal functioning (aggregate of Conflict Behavior Questionnaire, Inventory of Parent and Peer Attachment - Revised, Issues Checklist, and parent and adolescent coded interpersonal behaviors during a conflict negotiation task) | Measures will be aggregated using latent factor analysis. | 36 weeks |