Clinical trial NCT04708275: Treatment of Early Childhood Depression
Official title: A Waitlist Controlled Trial for Early Childhood Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Early Childhood Depression
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
First posted: 2021-01-13
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms, waitlist-controlled, randomized, single masked (outcomes assessor), single-center trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sum of depressive symptoms as indexed by the Preschool Age Psychiatric Assessment (PAPA) interview with the primary caregiver
timeFrame: post-treatment (after 20-25 weeks with weekly treatment sessions; on average after 7 months)
Secondary outcomes:
measure: Sum of PAPA depressive symptoms
timeFrame: mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
measure: Diagnosis of depression
timeFrame: mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
measure: Diagnosis of anxiety disorder
timeFrame: 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)
measure: Teacher-reported internalizing symptoms (TRF)
timeFrame: 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)
measure: Interview-based internalizing symptoms
timeFrame: 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)
measure: Caregiver-reported externalizing symptoms
timeFrame: 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)
measure: Teacher-reproted externalizing symptoms
timeFrame: 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)
measure: Cortisol secretion
timeFrame: 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)
measure: Internalizing symptoms reported by the primary caregiver (CBCL)
timeFrame: 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)
measure: Internalizing symptoms reported by the secondary caregiver (CBCL)
timeFrame: 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)
measure: Quality of the parent-child interaction (EAS)
timeFrame: 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)
measure: Quality of the parent-child interaction (MSSB)
timeFrame: 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 outcomes:
measure: Feasibility-related endpoints - Acceptability of PaCT
timeFrame: post-treatment (after 20-25 weeks with weekly treatment sessions)
measure: Feasibility-related endpoints - Acceptability of PaCT rated by children
timeFrame: post-treatment (after 20-25 weeks with weekly treatment sessions)
measure: Feasibility-related endpoints - Acceptability of PaCT rated by therapists
timeFrame: post-treatment (after 20-25 weeks with weekly treatment sessions)
measure: Feasibility-related endpoints - retention rates
timeFrame: post-treatment (after 20-25 weeks with weekly treatment sessions)
measure: Feasibility-related endpoints - adherence to PaCT
timeFrame: during all therapeutic sessions (20-25 weeks with weekly treatment sessions)
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Department of Child and Adolescent Psychiatry
Study officials:
affiliation: University of Leipzig - Department of Child and Adolescent Psychiatry
name: Kai von Klitzing, Prof.Dr.
role: STUDY_CHAIR
References: