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

Primary Purpose

Childhood Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCIT-ED
Parenting Wisely
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Mental Disorder focused on measuring Preschool, Parent-Child Relationship, Emotion Development, Therapy

Eligibility Criteria

48 Months - 83 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Early Emotional Development Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PCIT-ED

Parenting Wisely

Arm Description

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.

Online parenting training

Outcomes

Primary Outcome Measures

McArthur Health and Behavior Questionnaire
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.
Teacher Report Form
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.

Secondary Outcome Measures

Eyberg Child Behavior Inventory
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.
Parent-Child Interaction: Marble Run and Drawing Task
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.
Parenting Styles Questionnaire
The Parenting Style Questionnaire is an 81-item True/False measure that asks parents about their feelings regarding sadness, fear, and anger.
Parenting Styles and Dimensions Questionnaire
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.
Coping with Children's Negative Emotions Scale
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.

Full Information

First Posted
May 18, 2020
Last Updated
April 5, 2021
Sponsor
Washington University School of Medicine
Collaborators
The Jennings School District
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1. Study Identification

Unique Protocol Identification Number
NCT04399629
Brief Title
Trial of PCIT-ED in School for Preschoolers in Poverty
Acronym
PCIT-ED-ACES
Official Title
Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Jennings School District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Mental Disorder
Keywords
Preschool, Parent-Child Relationship, Emotion Development, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCIT-ED
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Parenting Wisely
Arm Type
Experimental
Arm Description
Online parenting training
Intervention Type
Behavioral
Intervention Name(s)
PCIT-ED
Intervention Description
12 sessions of PCIT-ED therapy
Intervention Type
Behavioral
Intervention Name(s)
Parenting Wisely
Intervention Description
Teaches parents how to set more effective limits
Primary Outcome Measure Information:
Title
McArthur Health and Behavior Questionnaire
Description
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.
Time Frame
completion of therapy (average of 12 weeks)
Title
Teacher Report Form
Description
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.
Time Frame
completion of therapy (average of 12 weeks)
Secondary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory
Description
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.
Time Frame
completion of therapy (average of 12 weeks)
Title
Parent-Child Interaction: Marble Run and Drawing Task
Description
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.
Time Frame
completion of therapy (average of 12 weeks)
Title
Parenting Styles Questionnaire
Description
The Parenting Style Questionnaire is an 81-item True/False measure that asks parents about their feelings regarding sadness, fear, and anger.
Time Frame
completion of therapy (average of 12 weeks)
Title
Parenting Styles and Dimensions Questionnaire
Description
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.
Time Frame
completion of therapy (average of 12 weeks)
Title
Coping with Children's Negative Emotions Scale
Description
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.
Time Frame
completion of therapy (average of 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan L Luby, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Early Emotional Development Program
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31376501
Citation
Luby JL, Gilbert K, Whalen D, Tillman R, Barch DM. The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):868-879. doi: 10.1016/j.jaac.2019.07.937. Epub 2019 Jul 31.
Results Reference
background
PubMed Identifier
30583852
Citation
Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2019 May 15;85(10):863-871. doi: 10.1016/j.biopsych.2018.11.021. Epub 2018 Dec 4.
Results Reference
background
PubMed Identifier
29921144
Citation
Luby JL, Barch DM, Whalen D, Tillman R, Freedland KE. A Randomized Controlled Trial of Parent-Child Psychotherapy Targeting Emotion Development for Early Childhood Depression. Am J Psychiatry. 2018 Nov 1;175(11):1102-1110. doi: 10.1176/appi.ajp.2018.18030321. Epub 2018 Jun 20.
Results Reference
background
Links:
URL
https://eedp.wustl.edu/
Description
Early Emotional Development Program Website

Learn more about this trial

Trial of PCIT-ED in School for Preschoolers in Poverty

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