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Clinical Trials/NCT02076425
NCT02076425
Completed
N/A

A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Washington University School of Medicine1 site in 1 country229 target enrollmentJanuary 13, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Disorder, Major
Sponsor
Washington University School of Medicine
Enrollment
229
Locations
1
Primary Endpoint
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 13, 2014
End Date
May 10, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children who meet all DSM-IV MDD symptom criteria (adjusted for development)

Exclusion Criteria

  • Children with serious chronic medical illness
  • 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)

Outcomes

Primary Outcomes

Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score

Time Frame: completion of therapy (average of 20 weeks)

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) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.

Secondary Outcomes

  • Preschool Feelings Checklist-Scale Version (PFC-Scale) Score(completion of therapy (average of 20 weeks))

Study Sites (1)

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