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

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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

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

Trial contacts and locations

1

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Central trial contact

Alayna D'Amico, BA; Dina Hirshfeld-Becker, PhD

Data sourced from clinicaltrials.gov

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