Early Intervention for Children at Risk for Anxiety

Mass General Brigham

Status

Completed

Conditions

Anxiety Disorder

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00865306

K08MH001538 (U.S. NIH Grant/Contract)

2000P000305

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

4 to 7 years old

Volunteers

No Healthy Volunteers

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anxious symptomatology, as indicated by Child Behavior Checklist [CBCL] scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.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.