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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Caregiver-Child Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)	Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.	Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Rating Scale-Revised (CDRS-R)	Clinician-administered semi-structured child interview of depression.	Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Inventory 2: Self Report (CDI2:SR)	Child self-report questionnaire assessing depressive symptoms.	Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Children's Depression Inventory 2:Parent (CDI2:P)	Parent-report questionnaire assessing child's depressive symptoms.	Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session
Clinical Global Impression (CGI)	Clinician assessment of child's symptom severity and level of improvement.	Pre-treatment, Stage 1, Stage 2, 3-month follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 16, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Depression, child, CBT, parent training, personalized treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 5K23MH093491 (U.S. NIH Grant/Contract)