Using SMART Experimental Design to Personalize Treatment for Child Depression

Last updated: September 27, 2021
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT01880814
5K23MH093491
  • Ages 7-14
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), orDepressive Disorder Not Otherwise Specified (NOS).
  2. If receiving psychiatric medication, dose should be stable for at least three monthsat enrollment.

Exclusion

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 beinghospitalized over the past year for a suicide attempt or for threatening to commitsuicide.
  7. Participation in additional psychotherapy.
  8. Caregiver and/or children do not speak English.

Study Design

Total Participants: 44
Study Start date:
June 01, 2013
Estimated Completion Date:
November 30, 2018

Study Description

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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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