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NCT02076425 · ClinicalTrials.gov registry record · NA

A Randomized Controlled Trial of PCIT-ED for Preschool Depression

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
229
Enrollment target

NCT02076425 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 229 participants.

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The verdict

NCT02076425, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
229 participants
Enrollment target

Study Summary

Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or "emotional competence." 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-, interval, and post-assessments. 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.

Interventions

  • BEHAVIORAL PCIT-ED

Trial Details

FieldValue
Enrollment Target 229 participants
Start Date 2014-01-13
Est. Completion 2018-05-10
Phase NA

What the Registry Record Tells You About NCT02076425

The ClinicalTrials.gov registry entry for NCT02076425 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PCIT-ED is the first listed.

NCT02076425 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02076425 about?

NCT02076425 is a clinical study titled "A Randomized Controlled Trial of PCIT-ED for Preschool Depression". Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely use...

What is the current status of trial NCT02076425?

This trial is currently completed. It is a NA study. The enrollment target is 229 participants. The study started on 2014-01-13. Estimated completion is 2018-05-10.

What interventions are being tested in trial NCT02076425?

The interventions under investigation include: PCIT-ED (BEHAVIORAL).

Who is sponsoring clinical trial NCT02076425?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.