Clinical trial NCT04399629: Trial of PCIT-ED in School for Preschoolers in Poverty
Official title: Preschool Based Prevention Targeting Emotion Development in Young Children Facing Adversity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Mental Disorder
Keywords: Preschool
Parent-Child Relationship
Emotion Development
Therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Jennings School District
First posted: 2020-05-22
Enrollment: 62
Sex: ALL
Minimum age (years): 48
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: McArthur Health and Behavior Questionnaire
timeFrame: completion of therapy (average of 12 weeks)
measure: Teacher Report Form
timeFrame: completion of therapy (average of 12 weeks)
Secondary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: completion of therapy (average of 12 weeks)
measure: Parent-Child Interaction: Marble Run and Drawing Task
timeFrame: completion of therapy (average of 12 weeks)
measure: Parenting Styles Questionnaire
timeFrame: completion of therapy (average of 12 weeks)
measure: Parenting Styles and Dimensions Questionnaire
timeFrame: completion of therapy (average of 12 weeks)
measure: Coping with Children's Negative Emotions Scale
timeFrame: completion of therapy (average of 12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Early Emotional Development Program
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joan L Luby, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.