Anxiety Disorder of ChildhoodNCT04039243
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
A study testing Being Brave and Parent Education in people with Anxiety Disorder of Childhood and Fear, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder of Childhood, Fear, Shyness
- What is being tested?
- Being Brave and Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- The parents are able to speak, understand, and read English
- The child must have a working knowledge of English.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
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.
- Conditions
- Anxiety Disorder of Childhood, Fear, Shyness
- Being tested
- Being Brave, Parent Education
- Keywords
- Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy
- Medical subject headings
- Shyness, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Being BraveBehavioural
Up to 12 weekly sessions
Parent EducationOther
Parents receive educational materials about helping children overcome shyness and fear
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol Receives: Behavioral: Being Brave |
| Parent Education | Active comparator | Parents receive educational materials about how to help young children overcome shyness and anxiety Receives: Other: Parent Education |
| Monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to four-month follow-up
CGI-Severity Ratings
Measured: Compared between groups at 4- and 8-month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start27 Sep 2019
- Primary completion1 Sep 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina R. Hirshfeld-Becker, Massachusetts General Hospital
- Investigators
- Dina Hirshfeld-Becker, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039243
- Sponsor's protocol ID
- 2018P000376
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
- ClinicalTrials.gov ID
- NCT04039243
- Acronym / sponsor ID
- 2018P000376
- Conditions
- Anxiety Disorder of Childhood, Fear, Shyness
- Keywords
- Anxiety disorders, Toddlers, Preschoolers, Cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Behavioral: Being BraveUp to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol |
| Parent Education | Active comparator | Other: Parent EducationParents receive educational materials about how to help young children overcome shyness and anxiety |
| Monitoring | No intervention | – |
Who may qualify
- Ages
- 21 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
- The parents are able to speak, understand, and read English
- The child must have a working knowledge of English.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Being BraveUp to 12 weekly sessions | Behavioural | Active Treatment |
| Parent EducationParents receive educational materials about helping children overcome shyness and fear | Other | Parent Education |
Primary outcome
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
Time frame: Baseline to four-month 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
CGI-Severity Ratings
Time frame: Compared between groups at 4- and 8-month FU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Anxiety Disorder of Childhood
Active, not recruiting
Using Personalized Assessments in the Treatment of Childhood OCD
Obsessive-Compulsive Disorder
Recruiting
VR Homework Exercises for Selective Mutism Treatment
Selective Mutism, Anxiety Disorder of Childhood
Not yet recruitingObservational study
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
Coccydynia, Chronic Pain
RecruitingPhase 1/2
Study of Cannabidiol and Neuroimaging on Stress
Early Life Adversity, Trauma
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Hirshfeld-Becker, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Being Brave and Parent Education in people with Anxiety Disorder of Childhood and Fear, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I) (time frame: Baseline to four-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.