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A Randomized Controlled Trial of PCIT-ED for Preschool Depression

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ClinicalTrials.gov Identifier: NCT02076425
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Behavioral: PCIT-ED Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of PCIT-ED for Preschool Depression
Actual Study Start Date : January 13, 2014
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : May 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: PCIT-ED
Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
 Behavioral: PCIT-ED
No Intervention: Wait List
No intervention while subjects wait for PCIT-ED in the second phase of the study.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Preschool Feelings Checklist-Scale Version (PFC-Scale) Score [ Time Frame: completion of therapy (average of 20 weeks) ]
    The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible.


Other Outcome Measures:
  1. Children's Global Assessment Scale (CGAS) Score [ Time Frame: completion of therapy (average of 20 weeks) ]
    The Children's Global Assessment Scale (CGAS) is a standardized instrument that measures children's global level of impairment completed by the clinician-rater. The possible range of values is 0-100, with 0 indicating the most severe global impairment.


Eligibility Criteria
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Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Children who are too ill to wait 18 weeks for treatment (e.g. having active suicidal ideation and/or in acute/serious distress)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076425


Locations
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United States, Missouri
Early Emotional Development Program
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Joan L Luby, M.D. Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] January 13, 2014

More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02076425    
Other Study ID Numbers: R01MH098454-02 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2014    Key Record Dates
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Washington University School of Medicine:
Depressive Disorder, Major
Child Psychiatry
Parent-Child Relationship
Therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders