Using SMART Experimental Design to Personalize Treatment for Child Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Dikla Eckshtain, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01880814
First received: June 10, 2013
Last updated: June 27, 2016
Last verified: June 2016
  Purpose

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.

Condition Intervention Phase
Depression
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Caregiver-Child Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using SMART Experimental Design to Personalize Treatment for Child Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.

  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up ] [ Designated as safety issue: No ]
    Clinician-administered semi-structured child interview of depression.

  • Children's Depression Inventory 2: Self Report (CDI2:SR) [ Time Frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing depressive symptoms.

  • Children's Depression Inventory 2:Parent (CDI2:P) [ Time Frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session ] [ Designated as safety issue: No ]
    Parent-report questionnaire assessing child's depressive symptoms.

  • Clinical Global Impression (CGI) [ Time Frame: Pre-treatment, Stage 1, Stage 2, 3-month follow-up ] [ Designated as safety issue: No ]
    Clinician assessment of child's symptom severity and level of improvement.


Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy (CBT)
Type of talk therapy that focuses on individual behavioral and cognitive skills.
Behavioral: Cognitive Behavioral Therapy (CBT)
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.
Experimental: Caregiver-Child Treatment
Type of talk therapy that involves the child and the caregiver and focuses on behavioral and cognitive skills.
Behavioral: Caregiver-Child Treatment
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.

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

Ages Eligible for Study:   7 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880814

Contacts
Contact: Dikla Eckshtain, Ph.D. 617-643-7821 deckshtain@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dikla Eckshtain    617-643-7821    deckshtain@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Dikla Eckshtain, PhD, Instructor in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01880814     History of Changes
Other Study ID Numbers: 5K23MH093491 
Study First Received: June 10, 2013
Last Updated: June 27, 2016
Health Authority: US: MassGH

Keywords provided by Massachusetts General Hospital:
Depression, child, cognitive behavioral treatment, parent training, personalized treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016