Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04039243
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : December 3, 2020
Information provided by (Responsible Party):
Dina R. Hirshfeld-Becker, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder of Childhood Fear Shyness Behavioral: Being Brave Other: Parent Education Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active Treatment
Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
Behavioral: Being Brave
Up to 12 weekly sessions

Active Comparator: Parent Education
Parents receive educational materials about how to help young children overcome shyness and anxiety
Other: Parent Education
Parents receive educational materials about helping children overcome shyness and fear

No Intervention: Monitoring

Primary Outcome Measures :
  1. Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I) [ Time Frame: Baseline to 1-Year Follow Up ]
    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 :
  1. Mean Change in number of anxiety disorders [ Time Frame: Baseline to 1-Year Follow Up ]
    As measured by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), a semi-structured interview used to assess present and lifetime severity of psychological disorders administered by a clinician blind to study arm

  2. Mean Change in Fear/Shyness Scores on the Early Childhood Behavior Questionnaire (ECBQ) (for those enrolled as 2-year-olds) [ Time Frame: Baseline to Post-Treatment ]
    The ECBQ Fear and Shyness scales include 23 items rated by a parent on a 7-point scale from 1 (Never) to 7 (Always)

  3. Mean Change in Anxiety Score on the Preschool Anxiety Scale (PAS) (for those enrolled as 3-year-olds) [ Time Frame: Baseline to 1-Year Follow Up ]
    The PAS consists of 28 items rated by a parent on a scale from 0 (Not True At All) to 4 (Very Often True). It assesses severity of anxiety in young children.

  4. Mean change in Internalizing scores on the Child Behavior Checklist (CBCL) and Caregiver Report Form (CRF) where available for Ages 1-1/2 - 5 years Scores [ Time Frame: Baseline to 1-Year Follow Up ]
    The CBCL and CRF are parent- and teacher/caregiver-completed questionnaires used to assess child behavior problems and social competence .

  5. Mean change in family function on the Family Life Interference Scale (FLIS). [ Time Frame: Baseline to 1-Year Follow Up ]
    The FLIS contains 19 items on a scale from 0 (Not True) to 2 (Very True) rated by a parent and is used to assesses the extent to which child behavior limits participation in activities typical of families with young children

  6. Mean change in Depression-Anxiety-Stress Scale stress rating [ Time Frame: Baseline to 1-Year Follow-Up ]
    This 42-item questionnaire, completed by the parent, assesses parental stress level

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The child scores >1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the 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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04039243

Layout table for location contacts
Contact: Jordan Holmen, BA 617-724-4906
Contact: Dina Hirshfeld-Becker, PhD 617-724-2572 DHIRSHFELD@PARTNERS.ORG

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Layout table for investigator information
Principal Investigator: Dina Hirshfeld-Becker, PhD Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Dina R. Hirshfeld-Becker, Co-Director, MGH Child CBT Program, Massachusetts General Hospital Identifier: NCT04039243    
Other Study ID Numbers: 2018P000376
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina R. Hirshfeld-Becker, Massachusetts General Hospital:
Anxiety disorders
Cognitive-behavioral therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders