Trials Sponsors Conditions Drugs Pricing

Conditions

Anxiety Disorder of Childhood Fear Shyness

Keywords

Anxiety disordersToddlersPreschoolersCognitive-behavioral therapy

Outcome Measures

Primary Outcomes (2)

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
CGI-Severity Ratings
Compared between groups at 4- and 8-month FU

Study Arms (3)

Active Treatment

EXPERIMENTAL

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

Behavioral: Being Brave

Parent Education

ACTIVE COMPARATOR

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

Other: Parent Education

Monitoring

NO INTERVENTION

Interventions

Being BraveBehavioral

Up to 12 weekly sessions

Active Treatment

Parent EducationOther

Parents receive educational materials about helping children overcome shyness and fear

Parent Education

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Months - 47 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

ShynessAnxiety Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental Disorders

Study Officials

Dina Hirshfeld-Becker, PhD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Co-Director, MGH Child CBT Program

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

September 27, 2019

Actual (reported)

Primary Completion

September 1, 2025

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Active Treatment

Parent Education

Monitoring

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Active Treatment

Parent Education

Monitoring

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations