Trial Outcomes & Findings for Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers (NCT NCT01416805)
NCT ID: NCT01416805
Last Updated: 2019-06-18
Results Overview
Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
14 Weeks
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
Computerized Cognitive Behavioral Therapy
Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|
Treatment as Usual
Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Computerized Cognitive Behavioral Therapy
Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|
Treatment as Usual
Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
Baseline characteristics by cohort
| Measure |
Computerized Cognitive Behavioral Therapy
n=49 Participants
Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|
Treatment as Usual
n=51 Participants
Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 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
|
9.4 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
9.82 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 WeeksPediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
Outcome measures
| Measure |
Computerized Cognitive Behavioral Therapy
n=49 Participants
Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|
Treatment as Usual
n=51 Participants
Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
|
|---|---|---|
|
PARS
|
11.4 units on a scale
Standard Deviation 5.2
|
14.7 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 14 weeksAnxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman \& Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.
Outcome measures
| Measure |
Computerized Cognitive Behavioral Therapy
n=49 Participants
Computerized Cognitive Behavioral Therapy: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|
Treatment as Usual
n=51 Participants
Treatment as usual: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
|
|---|---|---|
|
ADIS-C/P Clinical Severity Rating
|
3 units on a scale
Standard Deviation 1.3
|
4 units on a scale
Standard Deviation 1.4
|
Adverse Events
Computerized Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place