Intervention for Anxiety in Toddlers
Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
This study is testing a new online therapy program for parents and their toddlers aged 2-3 who are feeling anxious to see if it helps reduce their fear and shyness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Months to 47 Months |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04039243 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and effectiveness of a parent-child Cognitive Behavioral Therapy (CBT) intervention for 2-3-year-old children exhibiting elevated levels of fear, shyness, or anxiety. The intervention, called 'Being Brave,' involves remote sessions with parents and their children to help reduce anxiety symptoms. The study will assess the impact of this intervention on anxiety levels and follow up with participants one year later to determine the sustainability of the results.
Who should consider this trial
Good fit: Ideal candidates for this study are 2-3-year-old children with elevated temperamental fear or shyness, or diagnosed anxiety, along with their English-speaking parents.
Not a fit: Children with Autism Spectrum Disorder, severe disruptive behaviors, or other primary disorders that make CBT inappropriate will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety symptoms in young children, improving their emotional well-being and development.
How similar studies have performed: Other studies have shown promising results with CBT interventions for anxiety in young children, indicating that this approach is both viable and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Dina Hirshfeld-Becker, PhD — Massachusetts General Hospital
- Study coordinator: Alayna D'Amico, BA
- Email: adamico1@mgb.org
- Phone: 617-724-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.