Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Child Interaction Therapy-Emotion Development (PCIT-ED)
Developmental Education Parenting Intervention (DEPI)
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Preschool Onset Major Depressive Disorder, Preschool Depression, Emotion Development, Parent Child Interaction
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV symptom criteria for MDD based on parent report on PAPA
- Currently resides and has resided with primary caregiver for more than 6 months prior to study entry
Exclusion Criteria:
- Neurologic disorder (e.g., seizure disorder, closed head injury)
- Autistic spectrum disorder
- Has an IQ of less than 70, based on past testing or clear marked developmental delay
- Currently participating in psychotherapy
- If taking a psychotropic medication, must remain on stable dose of that medication throughout the course of study participation
Sites / Locations
- Washington University School of Medicine Early Emotional Development Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants assigned to Parent-Child Interaction Therapy-Emotional Development
Participants assigned to Developmental Education Parenting Intervention
Outcomes
Primary Outcome Measures
Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module
Secondary Outcome Measures
Full Information
NCT ID
NCT00595283
First Posted
January 4, 2008
Last Updated
March 20, 2013
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00595283
Brief Title
Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression
Official Title
Early Intervention in Depression: Dyadic Emotion Development Therapy for Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children.
Detailed Description
While growing up, children experience a range of emotions that change with development and environment. Although all young children experience sadness at times, a main characteristic of young children is their ability to experience joy and excitement in pleasurable childhood activities. When a child seems perpetually sad and no longer seems interested in previously enjoyed activities, the child may be showing signs of early onset depression. Children who are depressed are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. Two previous studies have established the validity of early onset depressive syndrome in preschoolers, confirming the need for treatment during the preschool period. This study will specifically adapt parent child interaction therapy (PCIT), a proven effective treatment for preschool disruptive disorders, for use in preschoolers with depression and will include an additional component to focus on emotion development (ED). The study will evaluate the effectiveness of PCIT-ED in treating depression in preschool children.
Participation in this two-stage study will last 16 weeks and will consist of initial assessments, 14 weeks of therapy, and a final assessment. Stage I will be used to assess the acceptability and reliability of the PCIT-ED manual, which will guide the treatment sessions. The protocol and assessment schedule will be the same for Stage I participants and Stage II participants assigned to PCIT-ED.
The initial assessments will include both child and parent participants. Child participants will be asked to complete a series of tasks, which will include playing with games and toys, making selections based on feelings, completing stories started by a research assistant, and participating in other activities designed to be fun and exciting. Parents will be interviewed about their child's feelings, emotions, behaviors, and development and also about how their child gets along at home, in school, and with friends. Parents will also answer questions concerning their own mental health and drug history, parenting style, and moods.
Participants will then be randomly assigned to receive PCIT-ED or Developmental Education Parenting Intervention (DEPI). Participants in both groups will attend fourteen 1-hour therapy sessions over a period of 14 weeks. For those assigned to PCIT-ED, most sessions will include both parent and child participants, but some will include parents only. During the parent-only sessions, the goals and procedures of upcoming therapy visits will be explained to parents. During sessions with both parent and child, participants will be taught positive parent-child interaction skills, ways to manage emotions, and relaxation techniques. After each therapy session, participants will be given homework that will involve practicing the skills learned in therapy sessions at home. At three points during the study, parents will also be asked to complete a brief questionnaire about their thoughts and feelings toward the therapy process. The therapy sessions for the participants assigned to DEPI will provide basic education in all areas of preschool development, with emphasis on social and emotional development. The initial assessments will be repeated for all participants at the end of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Preschool Onset Major Depressive Disorder, Preschool Depression, Emotion Development, Parent Child Interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants assigned to Parent-Child Interaction Therapy-Emotional Development
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants assigned to Developmental Education Parenting Intervention
Intervention Type
Behavioral
Intervention Name(s)
Parent Child Interaction Therapy-Emotion Development (PCIT-ED)
Other Intervention Name(s)
PCIT-ED
Intervention Description
PCIT-ED includes fourteen 1-hour therapy sessions over 14 weeks. Sessions will focus on positive parent-child interactions skills, ways to manage emotions, and relaxation techniques.
Intervention Type
Behavioral
Intervention Name(s)
Developmental Education Parenting Intervention (DEPI)
Other Intervention Name(s)
DEPI
Intervention Description
DEPI includes 14 weekly, 1-hour education sessions covering a range of child development and parenting topics. Classes are in a small group format and will emphasize emotional and social development.
Primary Outcome Measure Information:
Title
Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module
Time Frame
Measured at Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV symptom criteria for MDD based on parent report on PAPA
Currently resides and has resided with primary caregiver for more than 6 months prior to study entry
Exclusion Criteria:
Neurologic disorder (e.g., seizure disorder, closed head injury)
Autistic spectrum disorder
Has an IQ of less than 70, based on past testing or clear marked developmental delay
Currently participating in psychotherapy
If taking a psychotropic medication, must remain on stable dose of that medication throughout the course of study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan L. Luby, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine Early Emotional Development Program
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30768413
Citation
Hennefield L, Whalen DJ, Wood G, Chavarria MC, Luby JL. Changing Conceptions of Death as a Function of Depression Status, Suicidal Ideation, and Media Exposure in Early Childhood. J Am Acad Child Adolesc Psychiatry. 2019 Mar;58(3):339-349. doi: 10.1016/j.jaac.2018.07.909. Epub 2019 Jan 8.
Results Reference
derived
Learn more about this trial
Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression
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