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NCT00865306 · ClinicalTrials.gov registry record · NA
Early Intervention for Children at Risk for Anxiety
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT00865306: Completed NA study, sponsored by Massachusetts General Hospital.
NCT00865306 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865306, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- BEHAVIORAL "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 1998-03 |
| Est. Completion | 2005-01 |
| Phase | NA |
What the finished NCT00865306 record still lists
NCT00865306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." is the first listed.
NCT00865306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00865306 about?
NCT00865306 is a clinical study titled "Early Intervention for Children at Risk for Anxiety". 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 i...
What is the current status of trial NCT00865306?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 1998-03. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00865306?
The interventions under investigation include: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." (BEHAVIORAL).
Who is sponsoring clinical trial NCT00865306?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00865306's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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