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

Primary Purpose

Anxiety Disorder of Childhood, Fear, Shyness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Being Brave
Parent Education
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder of Childhood focused on measuring Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy

Eligibility Criteria

21 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Active Treatment

Parent Education

Monitoring

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
September 6, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04039243
Brief Title
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Official Title
Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder of Childhood, Fear, Shyness
Keywords
Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
Arm Title
Parent Education
Arm Type
Active Comparator
Arm Description
Parents receive educational materials about how to help young children overcome shyness and anxiety
Arm Title
Monitoring
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Being Brave
Intervention Description
Up to 12 weekly sessions
Intervention Type
Other
Intervention Name(s)
Parent Education
Intervention Description
Parents receive educational materials about helping children overcome shyness and fear
Primary Outcome Measure Information:
Title
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
Description
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
Time Frame
Baseline to four-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alayna D'Amico, BA
Phone
617-724-8711
Email
adamico1@mgb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Hirshfeld-Becker, PhD
Phone
617-724-2572
Email
DHIRSHFELD@MGB.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Hirshfeld-Becker, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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