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Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study

NCT04039243 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-15

No results posted yet for this study

Summary

The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.

Conditions

  • Anxiety Disorder of Childhood
  • Fear
  • Shyness

Interventions

BEHAVIORAL

Being Brave

Up to 12 weekly sessions

OTHER

Parent Education

Parents receive educational materials about helping children overcome shyness and fear

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Dina Hirshfeld-Becker, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2025-09-01
Completion
2026-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039243 on ClinicalTrials.gov