Early Intervention for Children at Risk for Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865306
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : October 13, 2010
Last Update Posted : October 13, 2010
National Institute of Mental Health (NIMH)
Information provided by:
Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention for Children at Risk for Anxiety
Study Start Date : March 1998
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.

Primary Outcome Measures :
  1. Number of Responders Based on Clinician Global Impression-Anxiety Improvement [ Time Frame: Post-Treatment (6-months from baseline) ]
    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)

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00865306

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Dina Hirshfeld-Becker, PhD Massachusetts General Hospital

Publications of Results:
Responsible Party: Dina Hirshfeld-Becker, Massachusetts General Hospital Identifier: NCT00865306     History of Changes
Other Study ID Numbers: 2000P000305
K08MH001538 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2009    Key Record Dates
Results First Posted: October 13, 2010
Last Update Posted: October 13, 2010
Last Verified: September 2010

Keywords provided by Massachusetts General Hospital:
Cognitive behavioral therapy
Young Children
Behavioral Inhibition

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders