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NCT04399629 · ClinicalTrials.gov registry record · NA
Trial of PCIT-ED in School for Preschoolers in Poverty
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT04399629 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 62 participants.
The verdict
NCT04399629, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL PCIT-ED
- BEHAVIORAL Parenting Wisely
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2021-01-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04399629
The ClinicalTrials.gov registry entry for NCT04399629 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 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 2 interventions - of which PCIT-ED is the first listed.
NCT04399629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04399629 about?
NCT04399629 is a clinical study titled "Trial of PCIT-ED in School for Preschoolers in Poverty". 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 ther...
What is the current status of trial NCT04399629?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2019-09-26. Estimated completion is 2021-01-19.
What interventions are being tested in trial NCT04399629?
The interventions under investigation include: PCIT-ED (BEHAVIORAL), Parenting Wisely (BEHAVIORAL).
Who is sponsoring clinical trial NCT04399629?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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