๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-13

Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study (NCT04039243)

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: Massachusetts General Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Massachusetts General Hospital โ€” Boston, Massachusetts

Age range: 21 Months to 47 Months

๐Ÿงช Interventions in This Study

  • Being Brave (BEHAVIORAL)
  • Parent Education (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Anxiety Disorder of Childhood

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—