A Randomized Controlled Trial of PCIT-ED for Preschool Depression

The Washington University

Status: Completed

Conditions: Depressive Disorder, Major

Treatments: Behavioral: PCIT-ED

Study type: Interventional

Funder types: Other

Identifiers

NCT02076425

R01MH098454-02

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 36 to 83 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 2 patient groups

PCIT-ED

Experimental group

Description:

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.

Treatment:

Behavioral: PCIT-ED

Wait List

No Intervention group

Description:

No intervention while subjects wait for PCIT-ED in the second phase of the study.