Status:
COMPLETED
Early Intervention for Children at Risk for Anxiety
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety Disorder
Eligibility:
All Genders
4-7 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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symptomatology, as indicated by Child Behavior Checklist \[CBCL\] scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.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
- 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.
Key Trial Info
Start Date :
March 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00865306
Start Date
March 1 1998
End Date
January 1 2005
Last Update
October 13 2010
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138