Back to resultsEarly Intervention for Children at Risk for Anxiety
Primary Purpose
Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Cognitive behavioral therapy, Anxiety, Preschoolers, Young Children, Parents, At-risk, Behavioral Inhibition
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anxious symptomatology, as indicated by Child Behavior Checklist [CBCL] scale scores (T-scores) on Anxious/Depressed or Withdrawn of 55 or higher.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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active CBT
No intervention (wait-list controls)
Arm Description
Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol.
Control children received no intervention.
Outcomes
Primary Outcome Measures
Number of Responders Based on Clinician Global Impression-Anxiety Improvement
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT00865306
First Posted
March 17, 2009
Last Updated
September 22, 2010
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00865306
Brief Title
Early Intervention for Children at Risk for Anxiety
Official Title
Early Intervention for Children at Risk for Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Cognitive behavioral therapy, Anxiety, Preschoolers, Young Children, Parents, At-risk, Behavioral Inhibition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active CBT
Arm Type
Experimental
Arm Description
Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol.
Arm Title
No intervention (wait-list controls)
Arm Type
No Intervention
Arm Description
Control children received no intervention.
Intervention Type
Behavioral
Intervention Name(s)
"Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Responders Based on Clinician Global Impression-Anxiety Improvement
Description
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)
Other Pre-specified Outcome Measures:
Title
Number of Children Free of Anxiety Disorders
Description
Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.
Time Frame
Post-Treatment (6-months from baseline)
Title
Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up
Description
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).
Time Frame
1-Year Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Hirshfeld-Becker, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20658807
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.
Results Reference
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Early Intervention for Children at Risk for Anxiety
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