Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression

March 20, 2013 updated by: Joan Luby, MD, Washington University School of Medicine

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

This study will evaluate the effectiveness of parent-child interaction therapy that includes an emotion development component in treating depression in preschool children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington University School of Medicine Early Emotional Development Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Participants assigned to Parent-Child Interaction Therapy-Emotional Development
Behavioral: Parent Child Interaction Therapy-Emotion Development (PCIT-ED)
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.
Other Names:
  • PCIT-ED
ACTIVE_COMPARATOR: 2
Participants assigned to Developmental Education Parenting Intervention
Behavioral: Developmental Education Parenting Intervention (DEPI)
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.
Other Names:
  • DEPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression diagnosis and severity using the Preschool-Age Psychiatric Assessment (PAPA) for major depressive disorder (MDD) module
Time Frame: Measured at Week 14
Measured at Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Joan L. Luby, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (ESTIMATE)

January 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH080163 (NIH)
  • DSIR 84-CTS (Division of Services and Intervention Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Parent Child Interaction Therapy-Emotion Development (PCIT-ED)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe