Trials / Active Not Recruiting
Active Not RecruitingNCT04039243
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Months – 47 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Being Brave | Up to 12 weekly sessions |
| OTHER | Parent Education | Parents receive educational materials about helping children overcome shyness and fear |
Timeline
- Start date
- 2019-09-27
- Primary completion
- 2025-09-01
- Completion
- 2026-06-01
- First posted
- 2019-07-31
- Last updated
- 2026-01-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04039243. Inclusion in this directory is not an endorsement.