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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH077312 | U.S. NIH Grant/Contract | View source | |
| R01MH077312-01 | U.S. NIH Grant/Contract | View source | |
| DDTR B4-TBI | Other Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.
Anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. The children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. Previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapeutic interventions. In children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. This study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders.
Participation in this study will last 1 year. First, interested participants will be asked to perform a screening assessment. This will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. If, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. Child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. Child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour intervention visits, during which participants will learn skills to reduce anxiety. After completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. In addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks, 6 months, and 12 months after entering the study. All participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-based CBT | Experimental | Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. |
|
| Information Monitoring | Placebo Comparator | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based CBT | Behavioral | Eight, 1-hour weekly sessions with a trained clinician. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) | The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues. This interview will be administered by a trained staff member and will utilize information from both parents and children. This interview will be used to determine the presence or absence of an anxiety disorder for children in this study. . | 12 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Golda S. Ginsburg, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34647197 | Derived | Slade EP, Ginsburg GS, Riddle MA. Cost-benefit Analysis of the Coping and Promoting Strength Program. Prev Sci. 2021 Nov;22(8):1096-1107. doi: 10.1007/s11121-021-01309-5. Epub 2021 Oct 14. | |
| 33070244 | Derived | Ginsburg GS, Tein JY, Riddle MA. Preventing the Onset of Anxiety Disorders in Offspring of Anxious Parents: A Six-Year Follow-up. Child Psychiatry Hum Dev. 2021 Aug;52(4):751-760. doi: 10.1007/s10578-020-01080-8. Epub 2020 Oct 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Family-based CBT | Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician. |
| FG001 | Information Monitoring | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Family-based CBT | Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician. |
| 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, Continuous | Mean |
| 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 | Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) | The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues. This interview will be administered by a trained staff member and will utilize information from both parents and children. This interview will be used to determine the presence or absence of an anxiety disorder for children in this study. . | Posted | Number | participants with anxiety diagnosis | 12 months post-treatment |
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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 | Family-based CBT | Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Golda Ginsburg | The Johns Hopkins University School of Medicine | 410-955-1544 | gginsbu@jhmi.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Information Monitoring |
| Behavioral |
Packet providing information on strategies for coping with anxiety |
|
| 28145769 | Derived | Schleider JL, Ginsburg GS, Drake K. Perceived Peer Victimization Predicts Anxiety Outcomes in a Prevention Program for Offspring of Anxious Parents. J Clin Child Adolesc Psychol. 2018;47(sup1):S255-S263. doi: 10.1080/15374416.2016.1270831. Epub 2017 Feb 1. |
| 26404420 | Derived | Ginsburg GS, Drake KL, Tein JY, Teetsel R, Riddle MA. Preventing Onset of Anxiety Disorders in Offspring of Anxious Parents: A Randomized Controlled Trial of a Family-Based Intervention. Am J Psychiatry. 2015 Dec;172(12):1207-14. doi: 10.1176/appi.ajp.2015.14091178. Epub 2015 Sep 25. |
| BG001 | Information Monitoring | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Family-based CBT | Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician. |
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|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Information Monitoring | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety | 0 | 66 | 0 | 66 |
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