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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2026-06-01

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.

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Detailed Description

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Conditions

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Anxiety Disorder of Childhood Fear Shyness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active Treatment

Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol

Group Type EXPERIMENTAL

Being Brave

Intervention Type BEHAVIORAL

Up to 12 weekly sessions

Parent Education

Parents receive educational materials about how to help young children overcome shyness and anxiety

Group Type ACTIVE_COMPARATOR

Parent Education

Intervention Type OTHER

Parents receive educational materials about helping children overcome shyness and fear

Monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Being Brave

Up to 12 weekly sessions

Intervention Type BEHAVIORAL

Parent Education

Parents receive educational materials about helping children overcome shyness and fear

Intervention Type OTHER

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).

Minimum Eligible Age

21 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes