NCT00595283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

January 4, 2008

Last Update Submit

March 20, 2013

Conditions

Keywords

Preschool Onset Major Depressive DisorderPreschool DepressionEmotion DevelopmentParent Child Interaction

Outcome Measures

Primary Outcomes (1)

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

    Measured at Week 14

Study Arms (2)

1

EXPERIMENTAL

Participants assigned to Parent-Child Interaction Therapy-Emotional Development

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

2

ACTIVE COMPARATOR

Participants assigned to Developmental Education Parenting Intervention

Behavioral: Developmental Education Parenting Intervention (DEPI)

Interventions

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.

Also known as: PCIT-ED
1

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.

Also known as: DEPI
2

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine Early Emotional Development Program

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Joan L. Luby, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations