Using SMART Experimental Design to Personalize Treatment for Child Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Caregiver-Child Treatment

• Registration Number: NCT01880814
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-16
• Study First Posted: 2013-06-19
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2020-08
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy (CBT)	Cognitive Behavioral Therapy (CBT)	Type of talk therapy that focuses on individual behavioral and cognitive skills.
Caregiver-Child Treatment	Caregiver-Child Treatment	Type of talk therapy that involves the child and the caregiver and focuses on behavioral and cognitive skills.

Primary Outcome Measures

Name	Time	Method
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)	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.
Children's Depression Inventory 2:Parent (CDI2:P)	Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session	Parent-report questionnaire assessing child's depressive symptoms.
Children's Depression Rating Scale-Revised (CDRS-R)	Pre-treatment, Stage 1, Stage 2, 3-month follow-up	Clinician-administered semi-structured child interview of depression.
Children's Depression Inventory 2: Self Report (CDI2:SR)	Pre-treatment, Stage 1, Stage 2, 3-month follow-up	Child self-report questionnaire assessing depressive symptoms.
Clinical Global Impression (CGI)	Pre-treatment, Stage 1, Stage 2, 3-month follow-up	Clinician assessment of child's symptom severity and level of improvement.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States