Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol |
|
| Parent Education | Active Comparator | Parents receive educational materials about how to help young children overcome shyness and anxiety |
|
| Monitoring | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Being Brave | Behavioral | Up to 12 weekly sessions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I) | 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 | Baseline to four-month follow-up |
| CGI-Severity Ratings | Compared between groups at 4- and 8-month FU |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dina Hirshfeld-Becker, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D012792 | Shyness |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Parent Education |
| Other |
Parents receive educational materials about helping children overcome shyness and fear |
|