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

January 13, 2026 updated by: Dina R. Hirshfeld-Becker, Massachusetts General Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The child scores >1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores >1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent
  • The parents are able to speak, understand, and read English
  • The child must have a working knowledge of English.

Exclusion Criteria:

  • Autism Spectrum Disorder (ASD) or global developmental delay in the child
  • The child has disruptive behavior so severe as to interfere with participation in intervention sessions
  • The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
Behavioral: Being Brave
Up to 12 weekly sessions
Active Comparator: Parent Education
Parents receive educational materials about how to help young children overcome shyness and anxiety
Other: Parent Education
Parents receive educational materials about helping children overcome shyness and fear
No Intervention: Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
Time Frame: Baseline to four-month follow-up
The CGI-I is a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse). It will be rated by a clinician interviewer blind to treatment condition
Baseline to four-month follow-up
CGI-Severity Ratings
Time Frame: Compared between groups at 4- and 8-month FU
Compared between groups at 4- and 8-month FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Dina Hirshfeld-Becker, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P000376

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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