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Active, Not Recruiting

NCT Number: NCT04039243

Addressing Anxiety in 2-3-Year-Olds: A Pilot 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Disorder of Childhood Anxiety Disorders Behavior Fear Mental Disorders Shyness Social Behavior

Age range

21 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Being Brave

Behavioral

Up to 12 weekly sessions

Parent Education

Other

Parents receive educational materials about helping children overcome shyness and fear

Primary outcomes

  1. 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

  2. CGI-Severity Ratings

    Time frame: Compared between groups at 4- and 8-month FU

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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