Early Intervention for Children at Risk for Anxiety

NCT00865306 | Completed Results

• 2 other identifiers: 2000P000305K08MH001538
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorder

Keywords

Cognitive behavioral therapy; Anxiety; Preschoolers; Young Children; Parents; At-risk; Behavioral Inhibition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Children Free of Anxiety Disorders

  Post-Treatment (6-months from baseline)

• Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up

  1-Year Follow-Up

Study Arms (2)

Active CBT

EXPERIMENTAL

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."

No intervention (wait-list controls)

NO INTERVENTION

Control children received no intervention.

Interventions

"Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." BEHAVIORAL

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.

Active CBT

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• 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.

  PMID: 20658807 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Wait-list control condition Use of parent report in diagnostic interviews (necessary in this young age range) Small sample size

Results Point of Contact

• Title: Dina R. Hirshfeld-Becker, PhD
• Organization: Massachusetts General Hospital

dhirshfeld@partners.org

617-503-1408

Study Officials

• Dina Hirshfeld-Becker, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Child CBT Program

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 1998
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: April 24, 2026
• Results First Posted: October 13, 2010

Record last verified: 2026-04

Locations

US (1)