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

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ClinicalTrials.gov Identifier: NCT04039243
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dina R. Hirshfeld-Becker, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE September 27, 2019
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • 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
  • 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)
  • 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.
  • 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 .
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Official Title  ICMJE Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorder of Childhood
  • Fear
  • Shyness
Intervention  ICMJE
  • Behavioral: Being Brave
    Up to 12 weekly sessions
  • Other: Parent Education
    Parents receive educational materials about helping children overcome shyness and fear
Study Arms  ICMJE
  • Experimental: Active Treatment
    Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
    Intervention: Behavioral: Being Brave
  • Active Comparator: Parent Education
    Parents receive educational materials about how to help young children overcome shyness and anxiety
    Intervention: Other: Parent Education
  • No Intervention: Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Months to 47 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jordan Holmen, BA 617-724-4906 jholmen@mgh.harvard.edu
Contact: Dina Hirshfeld-Becker, PhD 617-724-2572 DHIRSHFELD@PARTNERS.ORG
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039243
Other Study ID Numbers  ICMJE 2018P000376
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dina R. Hirshfeld-Becker, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dina Hirshfeld-Becker, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP