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
Last Update Posted : June 27, 2018
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||229 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
No Intervention: Wait List
No intervention while subjects wait for PCIT-ED in the second phase of the study.
- Major Depressive Disorder Severity Score from the Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) [ Time Frame: completion of therapy (average of 20 weeks) ]The K-SADS-EC is a semi-structured diagnostic interview designed to assess current and past episodes of psychopathology in children according to DSM criteria. Probes and objective criteria are provided to rate individual symptoms. Primary diagnoses assessed include: Major Depression, Dysthymia, Mania, Hypomania, Bipolar, Agoraphobia, Separation Anxiety, Simple Phobia, Social Phobia, Generalized Anxiety, Obsessive Compulsive, Attention Deficit Hyperactivity, Conduct, Oppositional Defiant, Post-Traumatic Stress, and Adjustment Disorders. Revisions include adjusting/adding questions and threshold anchors reflecting developmentally appropriate symptom and diagnostic criteria for 3-6 year old children, removing sections less applicable to young children, editing probes to use parent-directed wording, and providing directions for clarifying symptom severity and genesis where necessary. The KSADS-EC was adapted from the KSADS-PL by Michael S. Gaffrey, Ph.D. and Joan L. Luby, M.D.
- Preschool Feelings Checklist-Scale (PFC-Scale) [ Time Frame: completion of therapy (average of 20 weeks) ]The PFC is a validated screening checklist with favorable sensitivity and specificity designed to capture preschoolers at high risk for MDD. The PFC-Scale, a 23 item measure adapted from the PFC, is a scale version of this measure designed and validated to capture changes in young child depression severity (similar to the Child Depression Inventory).
- Children's Global Assessment Scale (C-GAS) [ Time Frame: completion of therapy (average of 20 weeks) ]The C-GAS is a clinician anchored measure of impairment due to depressive symptoms. It is on a 0-100 scale, with 0 being greatest and 100 being least impairment.
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
|United States, Missouri|
|Early Emotional Development Program|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Joan L Luby, M.D.||Washington University School of Medicine|