Using SMART Experimental Design to Personalize Treatment for Child Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Caregiver-Child Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of CBT. If randomized to no treatment, termination session will be completed. If randomized to continuation of CBT, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of CBT or Caregiver-Child Treatment. Stage 2 will include six sessions and a termination session.; Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of Caregiver-Child Treatment. If randomized to no treatment, termination session will be completed. If randomized to continuation of Caregiver-Child Treatment, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of Caregiver-Child Treatment or CBT. Stage 2 will include six sessions and a termination session.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Depression, child, CBT, parent training, personalized treatment