Trial of PCIT-ED in School for Preschoolers in Poverty

Overview

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.

Full Title of Study: “Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 18, 2020

Interventions

  • Behavioral: PCIT-ED
    • 12 sessions of PCIT-ED therapy
  • Behavioral: Parenting Wisely
    • Teaches parents how to set more effective limits

Arms, Groups and Cohorts

  • 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.
  • Experimental: Parenting Wisely
    • Online parenting training

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 48 Months

Maximum Age: 83 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • The Jennings School District
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joan Luby, MD, Professor of Psychiatry – Washington University School of Medicine
  • Overall Official(s)
    • Joan L Luby, M.D., Principal Investigator, Washington University School of Medicine

References

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. 2019 Jul 31. pii: S0890-8567(19)31430-3. doi: 10.1016/j.jaac.2019.07.937. [Epub ahead of print]

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.