Treatment of Early Childhood Depression

NCT04708275 | Completed

• 1 other identifier: RCT-WAIT-SAD-KIDS
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Early Childhood Depression

Outcome Measures

Primary Outcomes (1)

• Sum of depressive symptoms as indexed by the Preschool Age Psychiatric Assessment (PAPA) interview with the primary caregiver

  Sum of depressive symptoms using Preschool Age Psychiatric Assessment (PAPA) at post-treatment in the treatment group compared to post-waiting period in the waitlist group (controlling for the respective pre-values) based on clinical interviews. The scale ranges from 0-9 symptoms and higher values indicate worse outcome.

  post-treatment (after 20-25 weeks with weekly treatment sessions; on average after 7 months)

Secondary Outcomes (12)

• Sum of PAPA depressive symptoms

  mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)

• Diagnosis of depression

  mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)

• Diagnosis of anxiety disorder

  pre-waitlist (before waiting period) / pre-treatment (within 3 weeks before start of intervention), post-treatment (after 20-25 weeks with weekly treatment sessions) and follow up (3 months after intervention)

• Teacher-reported internalizing symptoms (TRF)

  pre-waitlist (before waiting period)/pre-treatment (within 3 weeks before start intervention)/mid-treatment (after 12 weeks with weekly treatment sessions)/post-treatment (after 20-25 weeks with weekly treatment sessions)/FUP (3 months post intervention)

• Interview-based internalizing symptoms

  pre-waitlist (before waiting period), pre-treatment (within 3 weeks before start intervention), post-treatment (after 20-25 weeks with weekly treatment sessions), follow-up (3 months after intervention)

Other Outcomes (5)

• Feasibility-related endpoints - Acceptability of PaCT

  post-treatment (after 20-25 weeks with weekly treatment sessions)

• Feasibility-related endpoints - Acceptability of PaCT rated by children

  post-treatment (after 20-25 weeks with weekly treatment sessions)

• Feasibility-related endpoints - Acceptability of PaCT rated by therapists

  post-treatment (after 20-25 weeks with weekly treatment sessions)

Study Arms (2)

PaCT

EXPERIMENTAL

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.

Procedure: PaCT

Waitlist

ACTIVE COMPARATOR

PaCT after a waiting period (3 months)

Procedure: PaCT

Interventions

PaCT 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.

PaCT; Waitlist

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead
• Technische Universität Dresden: collaborator

Study Sites (1)

University of Leipzig - Department of Child and Adolescent Psychiatry

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kai von Klitzing, Prof.Dr.

  University of Leipzig - Department of Child and Adolescent Psychiatry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: 2 arms, waitlist-controlled, randomized, single masked (outcomes assessor), single-center trial

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: January 13, 2021
• Study Start: February 24, 2020
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after publication within 5 years
• Access Criteria: direct inquiry to coordinating investigators

Locations

DE (1)