Skip to main content
OpenTrials
Completed

NCT Number: NCT01880814

Using SMART Experimental Design to Personalize Treatment for Child Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • A disorder other than depression as primary diagnosis.
  • Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
  • Mental Retardation.
  • Psychotic Disorders and Schizophrenia.
  • Mania or Hypomania disorders.
  • 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.
  • Participation in additional psychotherapy.
  • Caregiver and/or children do not speak English.

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Caregiver-Child Treatment

Behavioral

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.

Primary outcomes

  1. Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)

    Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up

    Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.

  2. Children's Depression Rating Scale-Revised (CDRS-R)

    Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up

    Clinician-administered semi-structured child interview of depression.

  3. Children's Depression Inventory 2: Self Report (CDI2:SR)

    Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up

    Child self-report questionnaire assessing depressive symptoms.

  4. Children's Depression Inventory 2:Parent (CDI2:P)

    Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session

    Parent-report questionnaire assessing child's depressive symptoms.

  5. Clinical Global Impression (CGI)

    Time frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up

    Clinician assessment of child's symptom severity and level of improvement.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2013
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.