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

Mass General Brigham

Status: Enrolling

Conditions: Fear; Shyness; Anxiety Disorder of Childhood

Treatments: Behavioral: Being Brave; Other: Parent Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04039243

2018P000376

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 47 months old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Active Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Being Brave

Parent Education

Active Comparator group

Description:

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

Treatment:

Other: Parent Education

Monitoring

No Intervention group