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Using SMART Experimental Design to Personalize Treatment for Child Depression

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ClinicalTrials.gov Identifier: NCT01880814
Recruitment Status : Active, not recruiting
First Posted : June 19, 2013
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dikla Eckshtain, PhD, 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Caregiver-Child Treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using SMART Experimental Design to Personalize Treatment for Child Depression
Study Start Date : June 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880814


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Dikla Eckshtain, PhD, Instructor in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01880814     History of Changes
Other Study ID Numbers: 5K23MH093491 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Dikla Eckshtain, PhD, 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