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Clinical Trials/NCT04399629
NCT04399629
Completed
N/A

Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity

Washington University School of Medicine1 site in 1 country62 target enrollmentSeptember 26, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Mental Disorder
Sponsor
Washington University School of Medicine
Enrollment
62
Locations
1
Primary Endpoint
McArthur Health and Behavior Questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2019
End Date
January 19, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joan Luby, MD

Professor of Psychiatry

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Over the clinical threshold on the Teacher Report Form

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Parenting Styles and Dimensions Questionnaire(completion of therapy (average of 12 weeks))
  • Parent-Child Interaction: Marble Run and Drawing Task(completion of therapy (average of 12 weeks))
  • Eyberg Child Behavior Inventory(completion of therapy (average of 12 weeks))
  • Parenting Styles Questionnaire(completion of therapy (average of 12 weeks))
  • Coping with Children's Negative Emotions Scale(completion of therapy (average of 12 weeks))

Study Sites (1)

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