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| ID | Type | Description | Link |
|---|---|---|---|
| K08MH001538 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CBT | Experimental | Seven parent-only and 8-13 child-only sessions focusing on CBT for anxiety disorders using the "Being Brave" protocol. |
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| No intervention (wait-list controls) | No Intervention | Control children received no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents." | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Post-Treatment (6-months from baseline) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Children Free of Anxiety Disorders | Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition. | Post-Treatment (6-months from baseline) |
| Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina Hirshfeld-Becker, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20658807 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controlled Trial |
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| One-Year Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Intervention (Wait-list Controls) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | Participants | Post-Treatment (6-months from baseline) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active CBT |
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Wait-list control condition Use of parent report in diagnostic interviews (necessary in this young age range) Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dina R. Hirshfeld-Becker, PhD | Massachusetts General Hospital | 617-503-1408 | dhirshfeld@partners.org |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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). |
| 1-Year Follow-Up |
| Improved btw baseline and first session |
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| Sought treatment for conduct disorder |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | The mean age of the children was 5.4 years (SD 1.0). This value did not differ between groups. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Other Pre-specified | Number of Children Free of Anxiety Disorders | Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition. | Posted | Number | Participants | Post-Treatment (6-months from baseline) |
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| Other Pre-specified | Number of Responders Using Clinical Global Impression-Anxiety Improvement at 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). | We tabulated the number of children that were "much" or "very much" improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the "No intervention (wait-list controls)" followed up here had actually received CBT. | Posted | Number | Participants | 1-Year Follow-Up |
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| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | No Intervention (Wait-list Controls) | 0 | 30 | 0 | 30 |
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