Treatment of Early Childhood Depression

NCT ID: NCT04708275

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2024-05-02

Brief 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).

Detailed 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PaCT

Manualized Psychoanalytic short-term therapy (PaCT) for children with internalizing disorders, 20-25 sessions (1, 2). PaCT helps the child to resolve rigid conflictual internal representations/ working models by using interpretative and mentalizing techniques and drawing on therapeutic transference relationship with the child and the parent.

Group Type: EXPERIMENTAL

PaCT

Intervention Type: PROCEDURE

Manualized Psychoanalytic short-term therapy (PaCT) for children with internalizing disorders, 20-25 sessions (1, 2). PaCT helps the child to resolve rigid conflictual internal representations/ working models by using interpretative and mentalizing techniques and drawing on therapeutic transference relationship with the child and the parent.

Waitlist

PaCT after a waiting period (3 months)

Group Type: ACTIVE_COMPARATOR

PaCT

Intervention Type: PROCEDURE

Manualized Psychoanalytic short-term therapy (PaCT) for children with internalizing disorders, 20-25 sessions (1, 2). PaCT helps the child to resolve rigid conflictual internal representations/ working models by using interpretative and mentalizing techniques and drawing on therapeutic transference relationship with the child and the parent.

Interventions

PaCT

Manualized Psychoanalytic short-term therapy (PaCT) for children with internalizing disorders, 20-25 sessions (1, 2). PaCT helps the child to resolve rigid conflictual internal representations/ working models by using interpretative and mentalizing techniques and drawing on therapeutic transference relationship with the child and the parent.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 3 to 8 years
• DSM-5 depressive disorder (Major Depression, Dysthymia, Depression NOS), adapted for young children according to the AACAP criteria
• Written informed consent of patient's parents or guardian
• informed verbal assent from children (age >= 6 years)

Exclusion Criteria

• IQ < 70
• autism spectrum or schizophrenia spectrum disorder in the child
• insufficient German language skills to participate in treatment (child or caregiver)
• ongoing litigation regarding child custody
• concurrent intensive psychotherapy
• participation in other interventional trials
• suspected lack of compliance

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Lars White

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai von Klitzing, Prof.Dr.

Role: STUDY_CHAIR

University of Leipzig - Department of Child and Adolescent Psychiatry

Locations

University of Leipzig - Department of Child and Adolescent Psychiatry

Leipzig, , Germany

Countries

Germany

Other Identifiers

RCT-WAIT-SAD-KIDS

Identifier Type: -

Identifier Source: org_study_id