Using SMART Experimental Design to Personalize Treatment for Child Depression

Depression Clinical Trial

Official title:

Using SMART Experimental Design to Personalize Treatment for Child Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880814
• Other study ID #: 5K23MH093491
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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