Anxiety Disorders
Conditions
Keywords
Anxiety
Brief summary
This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.
Detailed description
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.
Interventions
BEHAVIORALFamily-based CBT
Eight, 1-hour weekly sessions with a trained clinician.
BEHAVIORALInformation Monitoring
Packet providing information on strategies for coping with anxiety
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Parents of child participant have a current, primary anxiety disorder
Exclusion criteria
* Child has an anxiety disorder or is currently in treatment for anxiety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) | 12 months post-treatment | 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. . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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 | 66 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to schedule | 9 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Family-based CBT | Information Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 8.53 years STANDARD_DEVIATION 7.76 | 8.86 years STANDARD_DEVIATION 1.85 | 8.69 years STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Caucasian | 58 participants | 57 participants | 115 participants |
| Race/Ethnicity, Customized other ethnicity/race | 12 participants | 9 participants | 21 participants |
| Region of Enrollment United States | 70 participants | 66 participants | 136 participants |
| Sex: Female, Male Female | 44 Participants | 32 Participants | 76 Participants |
| Sex: Female, Male Male | 26 Participants | 34 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 66 |
| serious Total, serious adverse events | 0 / 70 | 0 / 66 |
Outcome results
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. .
Time frame: 12 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Information Monitoring | Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) | 19 participants with anxiety diagnosis |
| Family-based CBT | Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) | 3 participants with anxiety diagnosis |