A Randomized Controlled Trial of PCIT-ED for Preschool Depression
NCT ID: NCT02076425
Last Updated: 2019-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
229 participants
INTERVENTIONAL
2014-01-13
2018-05-10
Brief Summary
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Preschoolers over 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.
Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show significantly increased rates of remission, greater reductions in MDD symptoms, and decreases in impairment; and 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 WL, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
PCIT-ED
Wait List
No intervention while subjects wait for PCIT-ED in the second phase of the study.
No interventions assigned to this group
Interventions
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PCIT-ED
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children with Autistic Spectrum Disorders (based on clinical diagnosis or Social Responsiveness Scale scores which will be administered when there is suspicion of an ASD)
* Children with significant speech delays
* Children with general developmental delays or IQ \< 70
* Children with chronic neurological problems/illnesses
* Children adopted after 12 months of age
* Children on antidepressants
* Children taking unstable doses of other psychotropic medications without antidepressant properties
* Children participating in ongoing psychotherapy
* Children in unstable placements (not with same caregiver for 6 months prior to study enrollment)
* Children who are too ill to wait 18 weeks for treatment (e.g. having active suicidal ideation and/or in acute/serious distress)
36 Months
83 Months
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Joan L Luby, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Early Emotional Development Program
St Louis, Missouri, United States
Countries
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References
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Luby J, Lenze S, Tillman R. A novel early intervention for preschool depression: findings from a pilot randomized controlled trial. J Child Psychol Psychiatry. 2012 Mar;53(3):313-22. doi: 10.1111/j.1469-7610.2011.02483.x. Epub 2011 Oct 31.
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.
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.
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.
Schwartz KTG, Chronis-Tuscano A, Tillman R, Whalen D, Gilbert KE, Luby J. Parent-child psychotherapy targeting emotion development: unpacking the impact of parental depression on child, parenting and engagement outcomes. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2491-2501. doi: 10.1007/s00787-022-02093-5. Epub 2022 Oct 10.
Donohue MR, Hoyniak CP, Tillman R, Barch DM, Luby J. Callous-Unemotional Traits as an Intervention Target and Moderator of Parent-Child Interaction Therapy-Emotion Development Treatment for Preschool Depression and Conduct Problems. J Am Acad Child Adolesc Psychiatry. 2021 Nov;60(11):1394-1403. doi: 10.1016/j.jaac.2021.03.018. Epub 2021 May 20.
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. 2020 Dec 1;88(11):879-887. doi: 10.1016/j.biopsych.2020.06.032.
Hoyniak CP, Whalen DJ, Barch D, Luby JL. Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development. Eur Child Adolesc Psychiatry. 2021 Sep;30(9):1463-1474. doi: 10.1007/s00787-020-01641-1. Epub 2020 Sep 15.
Whalen DJ, Gilbert KE, Luby JL. Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression. J Child Psychol Psychiatry. 2021 Jan;62(1):86-96. doi: 10.1111/jcpp.13263. Epub 2020 May 29.
Whalen DJ, Gilbert KE, Kelly D, Hajcak G, Kappenman ES, Luby JL, Barch DM. Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures. J Abnorm Child Psychol. 2020 Jan;48(1):91-108. doi: 10.1007/s10802-019-00585-8.
Gilbert K, Barch DM, Luby JL. The Overcontrol in Youth Checklist (OCYC): Behavioral and Neural Validation of a Parent-Report of Child Overcontrol in Early Childhood. Child Psychiatry Hum Dev. 2020 Feb;51(1):27-38. doi: 10.1007/s10578-019-00907-3.
Luby JL, Whalen D, Tillman R, Barch DM. Clinical and Psychosocial Characteristics of Young Children With Suicidal Ideation, Behaviors, and Nonsuicidal Self-Injurious Behaviors. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):117-127. doi: 10.1016/j.jaac.2018.06.031. Epub 2018 Oct 22.
Belden AC, Irvin K, Hajcak G, Kappenman ES, Kelly D, Karlow S, Luby JL, Barch DM. Neural Correlates of Reward Processing in Depressed and Healthy Preschool-Age Children. J Am Acad Child Adolesc Psychiatry. 2016 Dec;55(12):1081-1089. doi: 10.1016/j.jaac.2016.09.503. Epub 2016 Oct 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Early Emotional Development Program Website
Other Identifiers
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