Trial Outcomes & Findings for Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children (NCT NCT00847561)
NCT ID: NCT00847561
Last Updated: 2017-03-24
Results Overview
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. .
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
12 months post-treatment
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
66
|
|
Overall Study
COMPLETED
|
57
|
62
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Unable to schedule
|
9
|
1
|
Baseline Characteristics
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
Baseline characteristics by cohort
| Measure |
Family-based CBT
n=70 Participants
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.
|
Information Monitoring
n=66 Participants
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
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.53 years
STANDARD_DEVIATION 7.76 • n=93 Participants
|
8.86 years
STANDARD_DEVIATION 1.85 • n=4 Participants
|
8.69 years
STANDARD_DEVIATION 1.80 • n=27 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 participants
n=93 Participants
|
57 participants
n=4 Participants
|
115 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
other ethnicity/race
|
12 participants
n=93 Participants
|
9 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=93 Participants
|
66 participants
n=4 Participants
|
136 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 months post-treatmentThe 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. .
Outcome measures
| Measure |
Information Monitoring
n=66 Participants
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
|
Family-based CBT
n=70 Participants
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.
|
|---|---|---|
|
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
|
3 participants with anxiety diagnosis
|
Adverse Events
Family-based CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Golda Ginsburg
The Johns Hopkins University School of Medicine
Phone: 410-955-1544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place