Trial Outcomes & Findings for Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety (NCT NCT03720795)
NCT ID: NCT03720795
Last Updated: 2025-01-15
Results Overview
Clinician rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.
Results posted on
2025-01-15
Participant Flow
Participants were not pre-assigned to groups. If participants did not respond to Step One of treatment, then they were stepped up to Step Two. Those who did respond to treatment at Step One then they entered a maintenance phase
Participant milestones
| Measure |
Stepped Care CBT
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
Phase 1
STARTED
|
76
|
|
Phase 1
COMPLETED
|
64
|
|
Phase 1
NOT COMPLETED
|
12
|
|
Phase 2
STARTED
|
64
|
|
Phase 2
Entered Maintenance
|
20
|
|
Phase 2
Stepped Up to Step 2
|
44
|
|
Phase 2
COMPLETED
|
47
|
|
Phase 2
NOT COMPLETED
|
17
|
|
3 Month Follow Up
STARTED
|
47
|
|
3 Month Follow Up
Entered Maintenance
|
18
|
|
3 Month Follow Up
Stepped Up to Step 2
|
27
|
|
3 Month Follow Up
COMPLETED
|
45
|
|
3 Month Follow Up
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Stepped Care CBT
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
Phase 1
Lost to Follow-up
|
4
|
|
Phase 1
Withdrawal by Subject
|
6
|
|
Phase 1
Protocol Violation
|
1
|
|
Phase 1
Other
|
1
|
|
Phase 2
Lost to Follow-up
|
5
|
|
Phase 2
Withdrawal by Subject
|
10
|
|
Phase 2
Protocol Violation
|
2
|
|
3 Month Follow Up
Lost to Follow-up
|
2
|
Baseline Characteristics
Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety
Baseline characteristics by cohort
| Measure |
Stepped-Care CBT
n=76 Participants
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
Age, Categorical
<=18 years
|
76 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.86 years
STANDARD_DEVIATION 2.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
|
Clinical Global Impressions - Severity
|
3.66 units on a scale
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
Pediatric Anxiety Rating Scale (PARS)
|
21.54 units on a scale
STANDARD_DEVIATION 3.91 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.Population: 48 participants completed either the maintenance phase or Step Two of treatment
Clinician rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.
Outcome measures
| Measure |
Stepped Care CBT
n=48 Participants
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
7-item Pediatric Anxiety Rating Scale
|
11.87 Score on a scale
Standard Deviation 6.93
|
PRIMARY outcome
Timeframe: Mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.Population: 48 participants were considered completers of Step 2 or the Maintenance Phase. The count is the number of participants that are considered "much improved" or "very much improved" on the CGI-I
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
Outcome measures
| Measure |
Stepped Care CBT
n=48 Participants
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
Clinical Global Impression-Improvement
|
42 Participants
|
SECONDARY outcome
Timeframe: Baseline (before treatment), mid-treatment (on average 12 weeks), post-treatment (on average 24 week), 3 month follow up; Post-treatment scores are reported.Population: 48 participants either completed Step Two or the maintenance phase.
Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Outcome measures
| Measure |
Stepped Care CBT
n=48 Participants
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Stepped Care CBT: Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
|
|---|---|
|
Clinical Global Impression-Severity
|
1.88 Score on a scale
Standard Deviation .98
|
Adverse Events
Stepped Care CBT
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