Treatment of Early Childhood Depression

Overview

Depression is the single-most prevalent mental disorder across the lifespan, with a high burden of disease, and with a sudden rise to adult levels in adolescence. Yet, it often goes unnoticed that depressive symptoms are already common in early childhood (up to age 8) and frequently predate later depression. However, unlike adolescent depression for which well-established evidence based treatments (EBTs) are available, currently few or no EBTs exist for early childhood depression – a fundamental gap highlighted by both the American and German practice guidelines for childhood depression. This study aims to address the urgent need for EBTs in this area by testing 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 children with depressive disorders aged 3 to 8 years. PaCT involves 20-25 sessions in alternating settings (child-only, caregiver(s)-child, caregiver(s)-only) and targets rigid internal conflicts and representations/ working models underlying anxiety or depressive disorders. To this end, PaCT focuses on the interpersonal meaning of the child's symptoms within the child-caregiver relationship(s), drawing on the child-therapist relationship, using a combination of interpretative, play and mentalization-based techniques. A previous pilot study (N=30) administering PaCT to clinically referred young children with anxiety disorders (1/3 of whom also suffered comorbid depression), yielded a highly significant remission rate of 59.88% in the intent-to-treat analysis (ITT; 8/10 remission rate for children with anxiety and comorbid depressive disorder) relative to waitlist.

Full Title of Study: “A Waitlist Controlled Trial for Early Childhood Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 10, 2022

Detailed Description

The current feasibility trial will involve 62 clinically referred children meeting criteria for DSM-5 depressive disorders, randomized to PaCT (n=31) or waitlist (n=31). The primary aim is to assess changes in depressive symptoms and diagnoses following PaCT vs. waitlist, and as a function of therapeutic dose in order to determine effect sizes which can be used in power calculations for future large-scale clinical trials. Moreover, the investigators assess feasibility of PaCT in young children with depression (e.g., retention rates), adherence to the PaCT manual as well as treatment acceptability among children and their caregivers.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Waitlist
    • PaCT after a waiting period (3 months)

Clinical Trial Outcome Measures

Primary Measures

  • Sum of depressive symptoms as indexed by the Preschool Age Psychiatric Assessment (PAPA) interview with the primary caregiver
    • Time Frame: post-treatment (after 20-25 weeks with weekly treatment sessions; on average after 7 months)
    • 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.

Secondary Measures

  • Sum of PAPA depressive symptoms
    • Time Frame: mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
    • Sum of depressive symptoms using the PAPA. The scale ranges from 0-9 symptoms and higher values indicate worse outcome.
  • Diagnosis of depression
    • Time Frame: mid-treatment (after 12 weeks with weekly treatment sessions) and follow up (3 months after intervention)
    • occurrence of diagnosis of depression using PAPA
  • Diagnosis of anxiety disorder
    • Time Frame: 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)
    • occurrence of diagnosis of anxiety disorder using PAPA
  • Teacher-reported internalizing symptoms (TRF)
    • Time Frame: 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)
    • (Nursery-)teacher-rated internalizing symptoms using Teacher Report Form (TRF). The scale ranges from 0-70 with higher scores indicating worse outcomes.
  • Interview-based internalizing symptoms
    • Time Frame: 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)
    • Child self-reported internalizing symptoms using Berkeley Puppet Interview, the scale ranges from 1-182 with higher scores indicating better outcomes.
  • Caregiver-reported externalizing symptoms
    • Time Frame: 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)
    • Externalizing symptoms rated by caregiversusing Child Behavior Checklist. (CBCL 4-18) The scale ranges from 0-66 with higher scores indicating worse outcomes.
  • Teacher-reproted externalizing symptoms
    • Time Frame: 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)
    • Externalizing symptoms rated by teachers using Teacher Report Form (TRF). The scale ranges from 0-68 with higher scores indicating worse outcomes.
  • Cortisol secretion
    • Time Frame: 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)
    • hair-cortisol concentrations (HCC) in the first 3 cm scalp hair segment at posterior vertex (~cumulative secretion over last 3 months)
  • Internalizing symptoms reported by the primary caregiver (CBCL)
    • Time Frame: 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 rated by primary caregivers using Child Behavior Checklist (CBCL 4-18). The scale ranges from 0-62 with higher scores indicating worse outcomes.
  • Internalizing symptoms reported by the secondary caregiver (CBCL)
    • Time Frame: 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 rated by primary caregivers using Child Behavior Checklist (CBCL 4-18). The scale ranges from 0-62 with higher scores indicating worse outcomes.
  • Quality of the parent-child interaction (EAS)
    • Time Frame: 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)
    • 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.
  • Quality of the parent-child interaction (MSSB)
    • Time Frame: 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)
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leipzig
  • Collaborator
    • Technische Universit├Ąt Dresden
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lars White, Coordinating Investigator – University of Leipzig
  • Overall Official(s)
    • Kai von Klitzing, Prof.Dr., Study Chair, University of Leipzig – Department of Child and Adolescent Psychiatry
  • Overall Contact(s)
    • Lars Otto White, Dr. phil., +49 (0) 341 – 9724018, LarsOtto.White@medizin.uni-leipzig.de

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.