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Early Intervention for Children at Risk for Anxiety

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00865306
First received: March 17, 2009
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
Results First Received: July 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety Disorder
Intervention: Behavioral: "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment for the controlled trial occurred between February 2001 and January 2004. Children were recruited from the outpatient child psychiatry clinic at a general hospital, as well as through print ads in local newspapers and parent magazines, email advertisements to hospital employees, and posters at local pediatrics practices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We screened 103 children for the controlled trial, to enroll our target goal of 60-65 children. Of these 14 were ineligible (3 did not meet inclusion criteria, and 9 met exclusion criteria). Another 13 withdrew prior to completing baseline assessments, and 11 who did not complete baseline assessments were lost to follow-up. Thus 65 were enrolled.

Reporting Groups
  Description
Active CBT This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
No Intervention (Wait-list Controls) This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.

Participant Flow for 2 periods

 Period 1:   Controlled Trial
    Active CBT     No Intervention (Wait-list Controls)  
STARTED     34 [1]   30  
COMPLETED     29     28  
NOT COMPLETED     5     2  
Lost to Follow-up                 1                 1  
Difficulty commuting                 2                 0  
Improved btw baseline and first session                 1                 0  
Sought treatment for conduct disorder                 1                 0  
Withdrawal by Subject                 0                 1  
[1] 35 assigned to CBT. One child in trial had 0 anxiety disorders, so we excluded her from analysis.

Period 2:   One-Year Follow-Up
    Active CBT     No Intervention (Wait-list Controls)  
STARTED     29     15 [1]
COMPLETED     29     15  
NOT COMPLETED     0     0  
[1] Only controls who opted for CBT after the waitlist (n=17) were included. 2 were lost (15 included).



  Baseline Characteristics
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Reporting Groups
  Description
Active CBT No text entered.
No Intervention (Wait-list Controls) No text entered.
Total Total of all reporting groups

Baseline Measures
    Active CBT     No Intervention (Wait-list Controls)     Total  
Number of Participants  
[units: participants]
 		  34     30     64  
Age  
[units: participants]
 		     
<=18 years     34     30     64  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation 		  5.4  ± 1.0     5.4  ± 1.0     5.4  ± 1.0  
Gender  
[units: participants]
 		     
Female     17     17     34  
Male     17     13     30  
Region of Enrollment  
[units: participants]
 		     
United States     34     30     64  
[1] The mean age of the children was 5.4 years (SD 1.0). This value did not differ between groups.



  Outcome Measures
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1.  Primary:   Number of Responders Based on Clinician Global Impression-Anxiety Improvement   [ Time Frame: Post-Treatment (6-months from baseline) ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Number of Children Free of Anxiety Disorders   [ Time Frame: Post-Treatment (6-months from baseline) ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up   [ Time Frame: 1-Year Follow-Up ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Wait-list control condition Use of parent report in diagnostic interviews (necessary in this young age range) Small sample size  


Results Point of Contact:  
Name/Title: Dina R. Hirshfeld-Becker, PhD
Organization: Massachusetts General Hospital
phone: 617-503-1408
e-mail: dhirshfeld@partners.org


Publications of Results:


Responsible Party: Dina Hirshfeld-Becker, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00865306     History of Changes
Other Study ID Numbers: 2000P000305, K08MH001538
Study First Received: March 17, 2009
Results First Received: July 20, 2010
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board