Trial Outcomes & Findings for Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety (NCT NCT01919970)
NCT ID: NCT01919970
Last Updated: 2019-06-14
Results Overview
This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
After an average of 12 weeks (post-treatment)
Results posted on
2019-06-14
Participant Flow
Only 32 subjects were enrolled in this study (versus the N=40) indicated in the Protocol attached.
Participant milestones
| Measure |
Cognitive Behavioral Therapy Condition
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions.
|
Treatment as Usual
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
11
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy Condition
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions.
|
Treatment as Usual
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy Condition
n=14 Participants
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions.
|
Treatment as Usual
n=18 Participants
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 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
|
10.07 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
10 years
STANDARD_DEVIATION 2.83 • n=7 Participants
|
10.03 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After an average of 12 weeks (post-treatment)This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
Outcome measures
| Measure |
Cognitive Behavioral Therapy Condition
n=14 Participants
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions.
|
Treatment as Usual
n=18 Participants
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale
|
7.79 units on a scale
Standard Deviation 5.37
|
15.06 units on a scale
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: After an average of 12 weeks (Post-treatment)This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity. The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual).
Outcome measures
| Measure |
Cognitive Behavioral Therapy Condition
n=14 Participants
This arm is the experimental condition; it consists of 12 weekly CBT sessions. The therapy protocol will begin with an introductory education session which will include development of a fear hierarchy, followed by 11 sessions of in vivo exposures to feared triggers.
Cognitive Behavioral Therapy: This condition involves 12 weekly CBT sessions.
|
Treatment as Usual
n=18 Participants
This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
|
|---|---|---|
|
Clinical Global Impression - Severity Scale
|
2.25 units on a scale
Standard Deviation .87
|
3.67 units on a scale
Standard Deviation .69
|
Adverse Events
Cognitive Behavioral Therapy Condition
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