Using SMART Experimental Design to Personalize Treatment for Child Depression



Status:Active, not recruiting
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:7 - 14
Updated:4/17/2018
Start Date:June 2013
End Date:December 2018

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The purpose of the study is:

1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the
long-term goal of developing a personalized treatment for child depression.

2. To collect pilot data on ways to personalize treatment for child depression using
cognitive behavioral therapy (CBT), caregiver-child treatment, or both.

Child depression is among the most prevalent and impairing pediatric conditions and
constitutes a major public health concern. Unfortunately, treatment benefits are relatively
modest and short-lived with sizeable percentages of children who maintain depressive symptoms
following treatment. This problem may be addressed in part by personalizing treatment,
including determining which children will benefit from CBT, which children will benefit from
caregiver-child treatment, and which children will benefit from both. The goal of the current
study is to pilot test an innovative experimental design called Sequential, Multiple
Assignment, Randomized Trial (SMART), which is used for development of personalized
treatments, collect pilot data, and assess the acceptability and feasibility of using this
design, in preparation for a full-scale SMART in a larger clinical trial and for the
development of personalized treatment.

Inclusion Criteria:

1. Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or
Depressive Disorder Not Otherwise Specified (NOS).

2. If receiving psychiatric medication, dose should be stable for at least three months
at enrollment.

Exclusion Criteria:

1. A disorder other than depression as primary diagnosis.

2. Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.

3. Mental Retardation.

4. Psychotic Disorders and Schizophrenia.

5. Mania or Hypomania disorders.

6. Acute suicidal behavior and/or acute plan that require higher level of care, and being
hospitalized over the past year for a suicide attempt or for threatening to commit
suicide.

7. Participation in additional psychotherapy.

8. Caregiver and/or children do not speak English.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-7821
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from
Boston, MA
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