Using SMART Experimental Design to Personalize Treatment for Child Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Dikla Eckshtain, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01880814
First received: June 10, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 caregiver involvement in treatment. The goal of the current proposal is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, 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.


Condition Intervention Phase
Depression
Behavioral: Cognitive Behavioral Treatment (CBT)
Behavioral: Caregiver-Child Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 of Using SMART Experimental Design to Personalize Treatment for Child Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Semi-structured diagnostic interview with children and caregivers assessing present episode and lifetime history of psychiatric illness. All modules will be administered at pre-treatment to establish depression as a primary disorder. In later assessment points, only depression module will be administered.

  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Semi-structured child interview of depression.

  • Children's Depression Inventory 2: Self Report (CDI2:SR) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing depressive symptoms.

  • Children's Depression Inventory 2:Parent (CDI 2:P) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up, before each treatment session ] [ Designated as safety issue: No ]
    Parent report questionnaire assessing child's depressive symptoms.

  • Children's Depression Inventory 2: Self Report Short Version (CDI 2:SR[S]) [ Time Frame: Before each treatment session ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing depressive symptoms.

  • Clinical Global Impression (CGI) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Assessor assessment of child's symptom severity and level of improvement.


Secondary Outcome Measures:
  • Automatic Thoughts Questionnaire (ATQ) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing negative self-thoughts.

  • Children's Negative Cognitive Error Questionnaire (CNCEQ) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing cognitive distortions.

  • Parent Child Relationship Questionnaire - Child (PCRQ-C) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing relationship with the parent.

  • Parent Child Relationship Questionnaire - Parent (PCRQ-P) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing relationship with the child.

  • Parenting Stress Index - Short Form (PSI-SF) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing parenting stress.

  • Five Minute Speech Sample (FMSS) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent verbal report that is coded by a coder in order to assess expressed emotion (EE).

  • Beck Depression Inventory II (BDI-II) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing depressive symptoms.

  • Brief Symptom Inventory (BSI) [ Time Frame: Pre-treatment, 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing psychopathology.

  • Family Information Form [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
    Parent questionnaire of demographic information.

  • Treatment Services [ Time Frame: 6 weeks, 12 weeks, 3-month follow-up ] [ Designated as safety issue: No ]
    Parent report questionnaire of additional therapeutic services received throughout treatment.


Other Outcome Measures:
  • Therapeutic Alliance Scale for Children-Revised (TASC-r) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing the quality of alliance with the therapist.

  • Therapeutic Alliance Scale for Caregivers and Parents (TASCP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing the quality of alliance with the therapist.

  • Child Satisfaction Scale (CSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Child self-report questionnaire assessing satisfaction with the treatment.

  • Parent Satisfaction Scale (PSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Parent self-report questionnaire assessing satisfaction with the treatment.

  • Therapist Satisfaction Index (TSI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Therapist self-report questionnaire assessing satisfaction with the treatment.


Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Treatment (CBT)
Children will first be randomized into one of two initial treatments: individual Cognitive Behavioral Treatment (CBT) or Caregiver-Child Treatment. The individual CBT arm will be conducted once per week for six weeks. After the initial treatment, child's response to treatment will be evaluated. Responders will be re-randomized into no treatment or individual CBT (these sessions will focus on mastering the skills and enhancing fluency in use of the skills). Non-responders will be re-randomized into one of two treatments: individual CBT or Caregiver-Child Treatment. Sessions will be conducted once per week.
Behavioral: Cognitive Behavioral Treatment (CBT)
The components of the individual CBT manual include: (1) Problem Solving - operationalization of problems and solution brainstorm and evaluation, (2) Activity Scheduling - engagement in positive and mood enhancing activities, (3) Cognitive Restructuring - identification and change of negative and unrealistic thoughts into positive and realistic thoughts, (4) Relaxation - progressive muscle relaxation and brief relaxation, and (5) Social Skills Self-Modeling - strategies for presentation of positive and engaging self (e.g., smile) in social interactions, starting conversations, and joining groups.
Behavioral: Caregiver-Child Treatment
The components of the Caregiver-Child Treatment manual include: (1) Special Time - increasing quality time of caregiver with child; (2) Family Problem Solving - operationalization of problems that involve the caregiver and the child, solution brainstorming and systematic evaluation; (3) Positive Communication - praise, active listening, reflection, reducing blame, and increasing positive exchanges; (4) Communication: Negotiation and Conflict Resolution - communication skills, compromise, and realistic expectations; and (5) Positive Mood and Behavior Management - positive reinforcement of positive mood behaviors (e.g., positive affect and prosocial behaviors) and positive behavior (e.g., contingency management and behavioral contracting).
Experimental: Caregiver-Child Treatment
Children will first be randomized into one of two initial treatments: individual Cognitive Behavioral Treatment (CBT) or Caregiver-Child Treatment. The caregiver-child treatment arm will be conducted once per week for six weeks. After the initial treatment, child's response to treatment will be evaluated. Responders will be re-randomized into no treatment or Caregiver-Child Treatment (these sessions will focus on mastering the skills and enhancing fluency in use of the skills). Non-responders will be re-randomized into one of two treatments: Caregiver-Child Treatment or individual CBT. Sessions will be conducted once per week.
Behavioral: Cognitive Behavioral Treatment (CBT)
The components of the individual CBT manual include: (1) Problem Solving - operationalization of problems and solution brainstorm and evaluation, (2) Activity Scheduling - engagement in positive and mood enhancing activities, (3) Cognitive Restructuring - identification and change of negative and unrealistic thoughts into positive and realistic thoughts, (4) Relaxation - progressive muscle relaxation and brief relaxation, and (5) Social Skills Self-Modeling - strategies for presentation of positive and engaging self (e.g., smile) in social interactions, starting conversations, and joining groups.
Behavioral: Caregiver-Child Treatment
The components of the Caregiver-Child Treatment manual include: (1) Special Time - increasing quality time of caregiver with child; (2) Family Problem Solving - operationalization of problems that involve the caregiver and the child, solution brainstorming and systematic evaluation; (3) Positive Communication - praise, active listening, reflection, reducing blame, and increasing positive exchanges; (4) Communication: Negotiation and Conflict Resolution - communication skills, compromise, and realistic expectations; and (5) Positive Mood and Behavior Management - positive reinforcement of positive mood behaviors (e.g., positive affect and prosocial behaviors) and positive behavior (e.g., contingency management and behavioral contracting).

Detailed Description:

Childhood depression constitutes a major public health concern, requiring effective interventions. The effects of treatments for childhood depression are relatively modest and short-lived, with sizeable percentages of children who maintain depressive symptoms following treatment. A potential barrier to treatment success is the single uniform format of treatment protocols, addressing all depressed children similarly, regardless of clinical presentation. One strategy for addressing this barrier is to personalize treatment, fitting intervention to the specific needs of the children being targeted. This approach is consistent with the strategic plan of the National Institute of Mental Health (NIMH) to emphasize the development of personalized interventions.

Studies have documented the importance of family context in the development and maintenance of childhood depression; however, the limited number of clinical trials that involved caregivers provided mixed results, with only some youths benefiting from caregiver involvement in treatment. A logical first step in personalizing treatment is to develop decision rules about which children are likely to benefit from caregiver involvement in treatment, and at what point in treatment caregiver involvement should occur. The proposed study will take the first step toward addressing these key personalizing questions, using the Sequential, Multiple Assignment, Randomized Trial (SMART) design, an experimental method that is well-suited to the development of personalized treatments.

The proposed project will focus on the first step in the development of personalized treatment for depressed children, piloting use of the SMART design. The study has two aims. Aim 1 includes the refinement of the individual CBT and caregiver-child treatment manuals for use in the SMART trial. Aim 2 includes a pilot study of the SMART experimental design, with 48, 7-14 year-old children who meet criteria for Major Depressive Disorder and/or Dysthymic Disorder. The pilot study will provide information about the acceptability of the treatment manuals, assessments, and study procedures and about the feasibility of the two-step randomization used in the SMART design. The resulting information will inform the development of a full-scale properly-powered SMART trial (for a later study). The long-term objective is to use the SMART trial methods to guide development of personalized treatment for child depression.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current Major Depressive Disorder (MDD) and/or Dysthymic Disorder (DD) diagnosis.
  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.
  3. Psychotic Disorders.
  4. Suicidal behavior.
  5. Participation in additional psychotherapy.
  6. Caregiver and/or children do not speak English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880814

Contacts
Contact: Dikla Eckshtain, Ph.D. 617-643-7821 deckshtain@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dikla Eckshtain    617-643-7821    deckshtain@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Dikla Eckshtain, PhD, Instructor in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01880814     History of Changes
Other Study ID Numbers: 5K23MH093491
Study First Received: June 10, 2013
Last Updated: March 28, 2014
Health Authority: United States: National Institute of Mental Health

Keywords provided by 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

ClinicalTrials.gov processed this record on August 19, 2014