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

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

Tracking Information

• First Submitted Date: July 29, 2019
• First Posted Date: July 31, 2019
• Last Update Posted Date: December 3, 2020
• Actual Study Start Date: September 27, 2019
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Anxiety Disorder of Childhood
• Fear
• Shyness

Intervention

• Behavioral: Being Brave
  Up to 12 weekly sessions
• Other: Parent Education
  Parents receive educational materials about helping children overcome shyness and fear

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2019): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2022
• Estimated Primary Completion Date: September 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 21 Months to 47 Months (Child)
• Accepts Healthy Volunteers: Yes

Contacts

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: United States

Administrative Information

• NCT Number: NCT04039243
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Dina R. Hirshfeld-Becker, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dina Hirshfeld-Becker, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: September 2020