A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: PCIT-ED


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 83 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCIT-ED<br>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<br> <br> |
| No Intervention: Wait List<br>No intervention while subjects wait for PCIT-ED in the second phase of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score | 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. | completion of therapy (average of 20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool Feelings Checklist-Scale Version (PFC-Scale) Score | 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. | completion of therapy (average of 20 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Major, Child Psychiatry, Parent-Child Relationship, Therapy