ACTIVE_NOT_RECRUITING

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

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Conditions

Anxiety Disorder of ChildhoodFearShynessAnxiety disordersToddlersPreschoolersCognitive-behavioral therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-09-27
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04039243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Months to 47 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * The parents are able to speak, understand, and read English
  3. * The child must have a working knowledge of English.
  1. * Autism Spectrum Disorder (ASD) or global developmental delay in the child
  2. * The child has disruptive behavior so severe as to interfere with participation in intervention sessions
  3. * 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).

Contacts and Locations

Principal Investigator

Dina Hirshfeld-Becker, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Dina Hirshfeld-Becker, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-27
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2019-09-27
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Anxiety disorders
  • Toddlers
  • Preschoolers
  • Cognitive-behavioral therapy

Additional Relevant MeSH Terms

  • Anxiety Disorder of Childhood
  • Fear
  • Shyness