Using SMART Experimental Design to Personalize Treatment for Child Depression

NCT01880814 | Completed

• 1 other identifier: 5K23MH093491
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is:

1. 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. 2.To collect pilot data on ways to personalize treatment for child depression using cognitive behavioral therapy (CBT), caregiver-child treatment, or both.

Conditions

Depression

Keywords

Depression, child, CBT, parent training, personalized treatment

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Type of talk therapy that focuses on individual behavioral and cognitive skills.

Behavioral: Cognitive Behavioral Therapy (CBT)

Caregiver-Child Treatment

EXPERIMENTAL

Type of talk therapy that involves the child and the caregiver and focuses on behavioral and cognitive skills.

Behavioral: Caregiver-Child Treatment

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT)

Caregiver-Child Treatment BEHAVIORAL

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.

Caregiver-Child Treatment

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or Depressive Disorder Not Otherwise Specified (NOS).
• If receiving psychiatric medication, dose should be stable for at least three months at enrollment.

You may not qualify if:

• A disorder other than depression as primary diagnosis.
• Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
• Mental Retardation.
• Psychotic Disorders and Schizophrenia.
• Mania or Hypomania disorders.
• 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.
• Participation in additional psychotherapy.
• Caregiver and/or children do not speak English.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Color Vision Defects

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychology

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 29, 2021

Record last verified: 2020-08

Locations

US (1)