All research
Oxytocin 2021-04-01 ClinicalTrials

Protocol Outlines Brief Emotion Focused Therapy for Preschoolers with Anxiety Disorders, Assessing Psychopathology and Biomarkers

A Brief Emotion Focused Therapy for Preschoolers With Anxiety Disorders

Background

Anxiety disorders in preschoolers are prevalent and can significantly impact development, yet effective, brief, and developmentally appropriate interventions are often lacking. Traditional therapies may be too lengthy or not specifically target the emotional regulation deficits seen in very young children. This study addresses a critical gap for preschool anxiety disorders by proposing a novel, short-term, emotion-focused therapy, aiming to provide an accessible and targeted approach that considers the unique developmental stage of this population. Current standard-of-care might involve longer-term cognitive-behavioral therapies or family-based interventions, which can be resource-intensive.

Study Design

This study describes the protocol for a planned clinical trial involving 40 children with anxiety disorders, randomized into three groups: 1) a novel short-term dynamic play therapy, 2) dyadic therapy, or 3) a control group receiving no therapy. Participants will undergo comprehensive assessments at baseline and bi-monthly for six months. Primary endpoints include psychopathology (anxiety, depression, behavioral problems) using semi-structured interviews and self-reported questionnaires. Objective measures include EEG recordings for child-parent brain synchrony, and saliva sampling for Cortisol (CT), Dehydroepiandrosterone (DHEA), Oxytocin (OT), and Secretory Immunoglobulin A (SIgA). Father-mother-child interactions will be videotaped and analyzed, with narrative descriptions and voice analysis from parent interviews.

Results

This study describes a protocol for a planned clinical trial; therefore, no findings are available yet. The trial aims to assess the efficacy of a novel brief emotion-focused therapy in preschoolers with anxiety disorders by measuring changes in psychopathology, brain synchrony, and stress biomarkers over six months. The primary goal is to determine if participants make improvements toward their goals for motor function, arm use, and participation in life situations following treatment, and if these improvements differ between the experimental and control groups. The study also seeks to establish the feasibility and acceptability of the protocol for potential application in a larger trial.

Why It Matters

If this brief emotion-focused therapy proves effective, it could offer a significantly more accessible and targeted intervention for young children with anxiety, potentially improving long-term developmental and mental health outcomes. Current therapeutic options for preschoolers can be lengthy, costly, or not optimally tailored to their unique emotional and cognitive needs. This protocol's comprehensive assessment, including objective biomarkers like cortisol, DHEA, oxytocin, SIgA, and EEG brain synchrony, could provide robust, multi-modal evidence for the therapy's efficacy. This could guide future clinical practice, inform the development of novel, evidence-based approaches to early childhood mental health, and potentially reduce the burden on families by offering a shorter, more intensive treatment option. The focus on dyadic interactions and parental involvement also suggests a holistic approach that could enhance generalization of skills.


anxiety preschoolers emotion-focused-therapy dyadic-therapy eeg cortisol
Source: clinicaltrials:NCT04978844 · Ingested Oct 28, 2026 · Digest: gemini-2.5-flash