Anxiety Disorders
Conditions
Keywords
Anxiety
Brief summary
This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.
Detailed description
Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care. Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.
Interventions
BEHAVIORALFamily-Based Anxiety Prevention Program
Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
BEHAVIORALEvaluation only
Participants will undergo evaluations without active treatment for 8 weeks.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mothers with a current, primary anxiety disorder * 7-12 year old children without an anxiety disorder
Exclusion criteria
* Mothers that do not have a current, primary anxiety disorder * 7-12 year old children with an anxiety disorder * 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children With Child Anxiety Diagnosis | 12 month | Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions. |
| Child Anxiety Diagnoses | 12 months | The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Family-based Prevention Program Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. | 20 |
| 2 Evaluation Only Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | 2 Evaluation Only | 1 Family-based Prevention Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.68 years STANDARD_DEVIATION 1.81 | 9.20 years STANDARD_DEVIATION 1.91 | 8.94 years STANDARD_DEVIATION 1.85 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Child Anxiety Diagnoses
The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Family-based Prevention Program | Child Anxiety Diagnoses | 0 participants |
| 2 Evaluation Only | Child Anxiety Diagnoses | 6 participants |
Primary
Number of Children With Child Anxiety Diagnosis
Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.
Time frame: 12 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Family-based Prevention Program | Number of Children With Child Anxiety Diagnosis | 20 participants |
| 2 Evaluation Only | Number of Children With Child Anxiety Diagnosis | 20 participants |