Early Intervention for Children at Risk for Anxiety

The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT) parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The 20-session intervention was first piloted openly in 9 children (between 3/10/98 and 1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial versus a monitoring-only wait-list control condition. Children had to either have an anxiety disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who had elevated symptoms of anxiety. In practice all children but one had at least one anxiety disorder at baseline. Children were blocked on presence or absence of parental anxiety disorder and randomized to the intervention or to a no-intervention wait-list control group. The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final parent session. Post-trial assessments were conducted at six months, and at one-year follow-up. The hypotheses were that the children assigned to the intervention group would show significantly better improvement (measured via Clinician Global Impression-Anxiety Improvement scale and absence of anxiety disorders) than children assigned to the wait-list condition.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorder
• Intervention / Treatment: Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The child is at risk for anxiety disorders, as indicated by at least one of the following:
• the child has behavioral inhibition (as determined by observed behavioral assessment);
• the child meets criteria for a DSM-IV or IIIR anxiety disorder (as determined by Kiddie-Schedule for Affective Disorders and Schizophrenia, Epidemiologic Version [K-SADS-E] with the mother); or
• the child has both a parent with lifetime history of anxiety disorder (as determined by direct Structured Clinical Interview for DSM-IV [SCID-IV] with both parents) and the child has anxious symptomatology, as indicated by Child Behavior Checklist [CBCL] scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.
• The child is between the ages of 4 and 7 years
• The child and parent(s) have a working command of English

Exclusion Criteria:

• Psychosis in parent or child
• Suicidality in parent or child
• Current alcohol or substance abuse in a parent
• Mental retardation or pervasive developmental disorder in parent or child
• Child in current psychiatric treatment
• Child judged too uncooperative or distractible to take part in intervention
• (In the controlled trial): Child judged clinically unable to wait six months for treatment. The following criteria are used in determining whether the child can wait for 6 months before receiving treatment:
• Suicidal Ideation
• Serious impairment in eating or sleeping habits
• Severe social isolation
• Severe impairment in school functioning or attendance
• Severe symptoms of obsessive-compulsive disorder (OCD)
• Clinical judgment based on the child's overall severity of symptoms and family functioning.
• All judgments of severity of symptoms/impairment are based on a clinician review of the Kiddie-SADS-E and a clinical evaluation with the family.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active CBT; Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol.	Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."; This is a cognitive-behavioral intervention modeled loosely after Kendall's "Coping Cat," which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments.
No Intervention: No intervention (wait-list controls); Control children received no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Responders Based on Clinician Global Impression-Anxiety Improvement	Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with "very much" or "much" improvement (CGI-Anxiety scores of 1 or 2)	Post-Treatment (6-months from baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Children Free of Anxiety Disorders	Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.	Post-Treatment (6-months from baseline)
Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up	Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated "1, very much improved" or "2, much improved." Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition).	1-Year Follow-Up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Dina Hirshfeld-Becker, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Hirshfeld-Becker DR, Masek B, Henin A, Blakely LR, Pollock-Wurman RA, McQuade J, DePetrillo L, Briesch J, Ollendick TH, Rosenbaum JF, Biederman J. Cognitive behavioral therapy for 4- to 7-year-old children with anxiety disorders: a randomized clinical trial. J Consult Clin Psychol. 2010 Aug;78(4):498-510. doi: 10.1037/a0019055.

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimated): March 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive behavioral therapy; Parents; Young Children; Preschoolers; At-risk; Behavioral Inhibition
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Coping Skills
• Other Study ID Numbers: 2000P000305; K08MH001538 (U.S. NIH Grant/Contract)