Trial of PCIT-ED in School for Preschoolers in Poverty

NCT04399629 | Completed

• 1 other identifier: 22-3250-18012
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Mental Disorder

Keywords

Preschool; Parent-Child Relationship; Emotion Development; Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  completion of therapy (average of 12 weeks)

• 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.

  completion of therapy (average of 12 weeks)

Secondary Outcomes (5)

• Eyberg Child Behavior Inventory

  completion of therapy (average of 12 weeks)

• Parent-Child Interaction: Marble Run and Drawing Task

  completion of therapy (average of 12 weeks)

• Parenting Styles Questionnaire

  completion of therapy (average of 12 weeks)

• Parenting Styles and Dimensions Questionnaire

  completion of therapy (average of 12 weeks)

• Coping with Children's Negative Emotions Scale

  completion of therapy (average of 12 weeks)

Study Arms (2)

PCIT-ED

ACTIVE COMPARATOR

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

Parenting Wisely

EXPERIMENTAL

Online parenting training

Behavioral: Parenting Wisely

Interventions

PCIT-ED BEHAVIORAL

12 sessions of PCIT-ED therapy

PCIT-ED

Parenting Wisely BEHAVIORAL

Teaches parents how to set more effective limits

Parenting Wisely

Eligibility Criteria

• Age: 48 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Over the clinical threshold on the Teacher Report Form

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Jennings School District: collaborator

Study Sites (1)

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Location

Related Publications (4)

• 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.

  PMID: 31376501 BACKGROUND

• 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.

  PMID: 30583852 BACKGROUND

• 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.

  PMID: 29921144 BACKGROUND

• Hennefield L, Gilbert K, Donohue MR, Tillman R, McCoy A, Diggs G, Paul ZA, Kohl PL, Luby JL. Early Emotion Development Intervention Improves Mental Health Outcomes in Low-Income, High-Risk Community Children. Child Psychiatry Hum Dev. 2025 Oct;56(5):1457-1471. doi: 10.1007/s10578-023-01639-1. Epub 2024 Jan 14.

  PMID: 38221601 DERIVED

Related Links

• Early Emotional Development Program Website

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Joan L Luby, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: September 26, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)