Treatment of Early Childhood Depression — PaCT_RCTwait  

Depression Clinical Trial

Official title: A Waitlist Controlled Trial for Early Childhood Depression

Status Recruiting

Clinical Trial Summary

Depression often occurs in early childhood. Moreover, later depression is frequently preceded by early childhood Depression (ECD). However, at present, there is a lack of evidence-based tratestments (EBTs) for ECD, posing a core research desideratum highlighted by both the American and German practice parameters for ECD. The current study seeks to redress this research gap, by evaluating the feasibility and dose-dependent effectiveness of manualized short-term psychoanalytic child psychotherapy (PaCT) compared to waitlist in a randomized controlled trial (RCT) among clinically referred 3 to 8-year-olds with ECD. Comprising 20-25 sessions in alternating settings (child-only, caregiver(s)-child, caregiver(s)-only), PaCT focuses on internal conflicts and representations underlying depressive disorders. PaCT targets the child-therapist relationship, using interpretative, play and mentalization-based techniques, aiming to elicit the interpersonal meaning of the child's symptoms within the child-caregiver relationship(s).

Clinical Trial Description

For this trial, 62 clinically referred children meeting criteria for DSM-5 depressive disorders, will be randomized randomized to PaCT (n=31) or waitlist (n=31). The overarching aim is to engender reduction in depressive symptoms and diagnoses following PaCT vs. waitlist in order to determine effect sizes which can be used in power calculations for future large-scale clinical trials. Moreover, effects of PaCT will also be examined at mid-treatment to provide a first insight into the necesary therapeutic dose. Moreover, the trial will also be used as a first opportunity to examine feasibility of PaCT in young children, treatment integrity, as well as treatment acceptability. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT04708275
• Study type: Interventional
• Source: University of Leipzig
• Contact: Lars Otto White, Dr. phil.
• Phone: +49 (0) 341 - 9724018
• Email: LarsOtto.White@medizin.uni-leipzig.de
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Completion date: June 10, 2024