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

NCT04039243 | Active Not Recruiting

• 1 other identifier: 2018P000376
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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; Shyness; Fear

Keywords

Anxiety disorders; Toddlers; Preschoolers; Cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

• Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)

  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

  Compared between groups at 4- and 8-month FU

Study Arms (3)

Active Treatment

EXPERIMENTAL

Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol

Behavioral: Being Brave

Parent Education

ACTIVE COMPARATOR

Parents receive educational materials about how to help young children overcome shyness and anxiety

Other: Parent Education

Monitoring

NO INTERVENTION

Interventions

Being Brave BEHAVIORAL

Up to 12 weekly sessions

Active Treatment

Parent Education OTHER

Parents receive educational materials about helping children overcome shyness and fear

Parent Education

Eligibility Criteria

• Age: 21 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Shyness; Anxiety Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Mental Disorders

Study Officials

• Dina Hirshfeld-Becker, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, MGH Child CBT Program

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: September 27, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)