Clinical trial NCT00865306: Early Intervention for Children at Risk for Anxiety
Official title: Early Intervention for Children at Risk for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Keywords: Cognitive behavioral therapy
Anxiety
Preschoolers
Young Children
Parents
At-risk
Behavioral Inhibition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-19
Enrollment: 65
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Responders Based on Clinician Global Impression-Anxiety Improvement
timeFrame: Post-Treatment (6-months from baseline)
Secondary outcomes:
Other outcomes:
measure: Number of Children Free of Anxiety Disorders
timeFrame: Post-Treatment (6-months from baseline)
measure: Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up
timeFrame: 1-Year Follow-Up
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dina Hirshfeld-Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.