NCT02076425

A Randomized Controlled Trial of PCIT-ED for Preschool Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 36 Months – 83 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
BEHAVIORAL	PCIT-ED

Timeline

• Start date: 2014-01-13
• Primary completion: 2018-03-31
• Completion: 2018-05-10
• First posted: 2014-03-03
• Last updated: 2019-12-02
• Results posted: 2019-12-02

Locations

1 site across 1 country: United States