Anxiety Disorder of Childhood, Fear, Shyness
Conditions
Keywords
Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy
Brief 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.
Interventions
BEHAVIORALBeing Brave
Up to 12 weekly sessions
OTHERParent Education
Parents receive educational materials about helping children overcome shyness and fear
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Months to 47 Months
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I) | Baseline to four-month follow-up | 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 |
| CGI-Severity Ratings | Compared between groups at 4- and 8-month FU | — |
Countries
United States
Outcome results
None listed