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

Not Applicable

Recruiting

• Conditions: Fear; Anxiety Disorder of Childhood; Shyness
• Interventions: Other: Parent Education; Behavioral: Being Brave

• Registration Number: NCT04039243
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2019-09-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent Education	Parent Education	Parents receive educational materials about how to help young children overcome shyness and anxiety
Active Treatment	Being Brave	Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol

Primary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States