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Purpose

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

Eligibility

Eligible Ages
Between 21 Months and 47 Months
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active Treatment 		Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
  • Behavioral: Being Brave
    Up to 12 weekly sessions
Active Comparator
Parent Education 		Parents receive educational materials about how to help young children overcome shyness and anxiety
  • Other: Parent Education
    Parents receive educational materials about helping children overcome shyness and fear
No Intervention
Monitoring

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Alayna D'Amico, BA
617-724-8711
adamico1@mgb.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.