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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety Disorder of Childhood, Fear, Shyness

Intervention / Treatment
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* Behavioral: Being Brave
* Other: Parent Education


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol | Behavioral: Being Brave<br>* Up to 12 weekly sessions<br>|
| Active Comparator: Parent Education<br>Parents receive educational materials about how to help young children overcome shyness and anxiety | Other: Parent Education<br>* Parents receive educational materials about helping children overcome shyness and fear<br>|
| No Intervention: Monitoring<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy