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Clinical Trials/NCT00595283
NCT00595283CompletedNot Applicable

Early Intervention in Depression: Dyadic Emotion Development Therapy for Preschool Children

Washington University School of Medicine2 sites in 1 country38 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
2
Primary Endpoint
Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

2

Active Comparator

Participants assigned to Developmental Education Parenting Intervention

Intervention: Developmental Education Parenting Intervention (DEPI) (Behavioral)

1

Experimental

Participants assigned to Parent-Child Interaction Therapy-Emotional Development

Intervention: Parent Child Interaction Therapy-Emotion Development (PCIT-ED) (Behavioral)

Outcomes

Primary Outcomes

Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module

Time Frame: Measured at Week 14

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joan Luby, MD

Principal Investigator

Washington University School of Medicine

Study Sites (2)

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