Early Intervention for Children at Risk for Anxiety

Anxiety Disorder Clinical Trial

Official title:

Early Intervention for Children at Risk for Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865306
• Other study ID #: 2000P000305
• Secondary ID: K08MH001538
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: September 22, 2010
• Start date: March 1998
• Est. completion date: January 2005

Study information

• Verified date: September 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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 tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No