A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized Controlled Trial of PCIT-ED for Preschool Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076425
• Other study ID #: R01MH098454-02
• Status: Completed
• Phase: N/A
• Start date: January 13, 2014
• Est. completion date: May 10, 2018

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: May 10, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 83 Months

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• PCIT-ED

Locations

Country	Name	City	State
United States	Early Emotional Development Program	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2019 May 15;85(10):863-87 — View Citation

Luby J, Lenze S, Tillman R. A novel early intervention for preschool depression: findings from a pilot randomized controlled trial. J Child Psychol Psychiatry. 2012 Mar;53(3):313-22. doi: 10.1111/j.1469-7610.2011.02483.x. Epub 2011 Oct 31. — View Citation

Luby JL, Barch DM, Whalen D, Tillman R, Freedland KE. A Randomized Controlled Trial of Parent-Child Psychotherapy Targeting Emotion Development for Early Childhood Depression. Am J Psychiatry. 2018 Nov 1;175(11):1102-1110. doi: 10.1176/appi.ajp.2018.18030 — View Citation

Luby JL, Gilbert K, Whalen D, Tillman R, Barch DM. The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression. J Am Acad Child Adolesc Psychiatry. 2019 Jul 31. pii: S0890-8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Children's Global Assessment Scale (CGAS) Score	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.	completion of therapy (average of 20 weeks)
Primary	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	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)

External Links

•   Early Emotional Development Program Website