Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
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
- Anxiety Disorder of Childhood
- Fear
- Shyness
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active Treatment |
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol |
|
|
Active Comparator Parent Education |
Parents receive educational materials about how to help young children overcome shyness and anxiety |
|
|
No Intervention Monitoring |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
