Clinical trial NCT01880814: Using SMART Experimental Design to Personalize Treatment for Child Depression
Official title: Using SMART Experimental Design to Personalize Treatment for Child Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression, child, CBT, parent training, personalized treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 44
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)
timeFrame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
measure: Children's Depression Inventory 2: Self Report (CDI2:SR)
timeFrame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
measure: Children's Depression Inventory 2:Parent (CDI2:P)
timeFrame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session
measure: Clinical Global Impression (CGI)
timeFrame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: