Trial Outcomes & Findings for Early Intervention for Children at Risk for Anxiety (NCT NCT00865306)
NCT ID: NCT00865306
Last Updated: 2010-10-13
Results Overview
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)
COMPLETED
NA
65 participants
Post-Treatment (6-months from baseline)
2010-10-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Controlled Trial
STARTED
|
34
|
30
|
|
Controlled Trial
COMPLETED
|
29
|
28
|
|
Controlled Trial
NOT COMPLETED
|
5
|
2
|
|
One-Year Follow-Up
STARTED
|
29
|
15
|
|
One-Year Follow-Up
COMPLETED
|
29
|
15
|
|
One-Year Follow-Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Controlled Trial
Lost to Follow-up
|
1
|
1
|
|
Controlled Trial
Difficulty commuting
|
2
|
0
|
|
Controlled Trial
Improved btw baseline and first session
|
1
|
0
|
|
Controlled Trial
Sought treatment for conduct disorder
|
1
|
0
|
|
Controlled Trial
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Early Intervention for Children at Risk for Anxiety
Baseline characteristics by cohort
| Measure |
Active CBT
n=34 Participants
|
No Intervention (Wait-list Controls)
n=30 Participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
5.4 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
5.4 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
30 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Treatment (6-months from baseline)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)
Outcome measures
| Measure |
Active CBT
n=34 Participants
|
No Intervention (Wait-list Controls)
n=30 Participants
|
|---|---|---|
|
Number of Responders Based on Clinician Global Impression-Anxiety Improvement
|
20 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-Treatment (6-months from baseline)Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.
Outcome measures
| Measure |
Active CBT
n=34 Participants
|
No Intervention (Wait-list Controls)
n=30 Participants
|
|---|---|---|
|
Number of Children Free of Anxiety Disorders
|
17 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-Year Follow-UpPopulation: 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.
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).
Outcome measures
| Measure |
Active CBT
n=29 Participants
|
No Intervention (Wait-list Controls)
n=15 Participants
|
|---|---|---|
|
Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up
|
24 Participants
|
11 Participants
|
Adverse Events
Active CBT
No Intervention (Wait-list Controls)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dina R. Hirshfeld-Becker, PhD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place