Treatment of Early Childhood Depression (PaCT_RCTwait)

A Waitlist Controlled Trial for Early Childhood Depression

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).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Procedure: PaCT

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • University of Leipzig - Department of Child and Adolescent Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: Waitlist; PaCT after a waiting period (3 months)	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of PAPA depressive symptoms	Sum of depressive symptoms using the PAPA. The scale ranges from 0-9 symptoms and higher values indicate worse outcome.	mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
Diagnosis of depression	occurrence of diagnosis of depression using PAPA	mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
Diagnosis of anxiety disorder	occurrence of diagnosis of anxiety disorder using PAPA	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)	(Nursery-)teacher-rated internalizing symptoms using Teacher Report Form (TRF). The scale ranges from 0-70 with higher scores indicating worse outcomes.	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	Child self-reported internalizing symptoms using Berkeley Puppet Interview, the scale ranges from 1-182 with higher scores indicating better outcomes.	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)
Caregiver-reported externalizing symptoms	Externalizing symptoms rated by caregiversusing Child Behavior Checklist. (CBCL 4-18) The scale ranges from 0-66 with higher scores indicating worse outcomes.	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)
Teacher-reproted externalizing symptoms	Externalizing symptoms rated by teachers using Teacher Report Form (TRF). The scale ranges from 0-68 with higher scores indicating worse outcomes.	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)
Cortisol secretion	hair-cortisol concentrations (HCC) in the first 3 cm scalp hair segment at posterior vertex (~cumulative secretion over last 3 months)	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)
Internalizing symptoms reported by the primary caregiver (CBCL)	internalizing symptoms rated by primary caregivers using Child Behavior Checklist (CBCL 4-18). The scale ranges from 0-62 with higher scores indicating worse outcomes.	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)
Internalizing symptoms reported by the secondary caregiver (CBCL)	internalizing symptoms rated by primary caregivers using Child Behavior Checklist (CBCL 4-18). The scale ranges from 0-62 with higher scores indicating worse outcomes.	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)
Quality of the parent-child interaction (EAS)	In an exploratory fashion, the investigators will test whether the quality of parent-child interaction improve after the intervention and whether this improvement in interaction quality is a mediator of the treatment effect. Quality of the parent-child interaction assessed by the Emotional Availability Scales (EAS), specifically four caregiver scales (1. sensitivity, 2. structuring, 3. nonintrusiveness, and 4. nonhostility) and two child scales (1.responsiveness to mother and 2. involvement of mother). Codes on the scales range from 1 to 7, with higher scores indicating better outcome.	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)
Quality of the parent-child interaction (MSSB)	In an exploratory fashion, the investigators will test whether the child's ability to mentalize improve after the intervention and whether improvment in this ability is a mediator of the treatment effect. Child's ability to mentalize assessed by the Process Scales (Hill et al., 2009) MacArthur Narrative Coding Manual (MNCM; Robsinson et al., 2002) using the indices for narrative coherence (range: 1-12), intentionality (range: 1-12), with higher scores indicating better outcome.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility-related endpoints - Acceptability of PaCT	Acceptability of PaCT rated by caregivers/ parents using Treatment evaluation questionnaire (FBB)	post-treatment (after 20-25 weeks with weekly treatment sessions)
Feasibility-related endpoints - Acceptability of PaCT rated by children	Acceptability of PACT rated by children: Items derived from the German version of Therapeutic Alliance Scales for Children (TASC) assessed by Berkeley Puppet Interview technique (BPI)	post-treatment (after 20-25 weeks with weekly treatment sessions)
Feasibility-related endpoints - Acceptability of PaCT rated by therapists	Acceptability of PaCT rated by therapists using Treatment evaluation questionnaire (FBB)	post-treatment (after 20-25 weeks with weekly treatment sessions)
Feasibility-related endpoints - retention rates	Acceptability of PaCT: retention rates - the investigators expect a high rate of retention until post-treatment (expected 85%-90%)	post-treatment (after 20-25 weeks with weekly treatment sessions)
Feasibility-related endpoints - adherence to PaCT	Adherence to PACT interventions: coding of session videos using a Q-sort rating	during all therapeutic sessions (20-25 weeks with weekly treatment sessions)

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Technische Universität Dresden
• Investigators: Study Chair: Kai von Klitzing, Prof.Dr., University of Leipzig - Department of Child and Adolescent Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Early Childhood Depression
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: RCT-WAIT-SAD-KIDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of the primary objective, published data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within 5 years, if the members of the TREAT-SAD-KIDS-trial group agree.
• IPD Sharing Time Frame: after publication within 5 years
• IPD Sharing Access Criteria: direct inquiry to coordinating investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No