Trial of PCIT-ED in School for Preschoolers in Poverty (PCIT-ED-ACES)

April 5, 2021 updated by: Joan Luby, MD, Washington University School of Medicine

Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity

A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED delivered by trained therapists in the school setting or an on-line parent training called "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and 40% to PW. The treatment will be provided to eligible children in the Jennings School District at the school site. In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes, and to investigate mediators and moderators of treatment response, participants will complete comprehensive pre- and post-assessments at Washington University School of Medicine Early Emotional Development Program.

Preschoolers over age 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED or PW.

Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show significantly increased rates of remission of behavioral problems, greater reductions in symptoms, and decreases in impairment. We hypothesize that they will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the PW, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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
      • Saint Louis, Missouri, United States, 63108
        • 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

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over the clinical threshold on the Teacher Report Form

Exclusion Criteria:

  • Autism
  • Major neurological disorder
  • Participating in active weekly individual or family therapy

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCIT-ED
Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
Behavioral: PCIT-ED
12 sessions of PCIT-ED therapy
Experimental: Parenting Wisely
Online parenting training
Behavioral: Parenting Wisely
Teaches parents how to set more effective limits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McArthur Health and Behavior Questionnaire
Time Frame: completion of therapy (average of 12 weeks)
The Health and Behavior Questionnaire was designed to assess children's mental health, physical health, and social and school functioning. The HBQ comprises multiple scales that measure children's symptoms (e.g., internalizing and externalizing symptoms and their subscales), physical health, social functioning (e.g., peer acceptance and rejection, prosocial behaviors), and school functioning (e.g., academic competence, school engagement). The HBQ also includes measures of children's health care utilization in the mental, physical, and school domains.
completion of therapy (average of 12 weeks)
Teacher Report Form
Time Frame: completion of therapy (average of 12 weeks)
This measure is used to obtain an overview of the child's behavior and functioning from the perspective of the teacher. The results of the form offer cross-informant comparisons in competencies, adaptive functioning and reported problems. This information is helpful for finding the child's strengths and where the child needs help.
completion of therapy (average of 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyberg Child Behavior Inventory
Time Frame: completion of therapy (average of 12 weeks)
The Eyberg Child Behavior Inventory (ECBI) is a measure that asks parents to report on a list of thirty-six conduct problem behaviors in their child. It is designed for children ages 2-16 years. The ECBI includes an Intensity Scale, which measures the frequency of each problem behavior, and a Problem Scale, which reflects parents' tolerance of the behaviors and the distress caused. The ECBI is intended to assess both the type of behavior problems and the degree to which parents find them problematic.
completion of therapy (average of 12 weeks)
Parent-Child Interaction: Marble Run and Drawing Task
Time Frame: completion of therapy (average of 12 weeks)
The marble run task and the drawing task are observational measures of parent-child interactions used in preschool aged children. In the marble run task, parents and children are asked to build a marble run, replicating a picture of a marble run. The drawing task asks parents and children to together decide on something to draw on a blank sheet of paper and each contribute individual lines to the drawing, while sharing one marker. Both tasks were designed to elicit mild stress while also asking parents and children to work together. Both of these tasks (each lasting approximately three minutes) asks parents to help their child with the task but not complete it for them. Participants are videotaped while engaging in these tasks, and parents' behavior and emotions are coded.
completion of therapy (average of 12 weeks)
Parenting Styles Questionnaire
Time Frame: completion of therapy (average of 12 weeks)
The Parenting Style Questionnaire is an 81-item True/False measure that asks parents about their feelings regarding sadness, fear, and anger.
completion of therapy (average of 12 weeks)
Parenting Styles and Dimensions Questionnaire
Time Frame: completion of therapy (average of 12 weeks)
The PSDQ is a 62-item questionnaire that is designed to assess parenting style. The parent is given a list of 62 behaviors and asked how much they and their spouse exhibit each behavior.
completion of therapy (average of 12 weeks)
Coping with Children's Negative Emotions Scale
Time Frame: completion of therapy (average of 12 weeks)
The CCNES assesses how parents typically respond to their child's negative emotions. Parents are given 12 hypothetical situations in which their child is upset or angry. Each situation is accompanied with 6 possible ways to respond to the child, and the parent is asked to rate the likelihood that they will use each response.
completion of therapy (average of 12 weeks)

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Collaborators

The Jennings School District

Investigators

  • Principal Investigator: Joan L Luby, M.D., 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

Helpful Links

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 (Actual)

September 26, 2019

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

January 19, 2021

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-3250-18012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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