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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: Completed NA study, sponsored by Washington University School of Medicine.
NCT02076425 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 229 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9)
Interventions
- BEHAVIORAL PCIT-ED
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2014-01-13 |
| Est. Completion | 2018-05-10 |
| Phase | NA |
What the finished NCT02076425 record still lists
NCT02076425 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which PCIT-ED is the first listed.
NCT02076425 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02076425's enrollment target sits among peer trials
229 468th of 2000 higher than 1,533 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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