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

Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039243
• Other study ID #: 2018P000376
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Alayna D'Amico, BA
• Phone: 617-724-8711
• Email: adamico1[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Months to 47 Months

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorder of Childhood
• Anxiety Disorders
• Fear
• Shyness

Intervention

Behavioral:
• Being Brave
Up to 12 weekly sessions

Other:
• Parent Education
Parents receive educational materials about helping children overcome shyness and fear

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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