Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
NCT Number: NCT00865306
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.
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Notify Me4 year–7 year
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02138, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
Time frame: Post-Treatment (6-months from baseline)
Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.
Time frame: 1-Year Follow-Up
Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated "1, very much improved" or "2, much improved." Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition).
Massachusetts General Hospital
Other
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