ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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
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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Primary Outcome Measure  Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Depression
Intervention  Behavioral: Parent Child Interaction Therapy-Emotion Development (PCIT-ED)
Behavioral: Developmental Education Parenting Intervention (DEPI)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  38
Start Date  October 2007
Completion Date October 2010
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 or taking psychotropic medication
Gender Both
Ages 3 Years to 6 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Jennifer D. Pautsch, MA     314-286-2730     pautschj@msnotes.wustl.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00595283
Organization ID R34 MH080163
Secondary IDs †† DSIR 84-CTS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Joan L. Luby, MD     Washington University School of Medicine    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date January 2008
First Received Date  January 4, 2008
Last Updated Date January 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers