Trial Outcomes & Findings for Kids FACE FEARS Comparative Effectiveness Research (NCT NCT03707158)
NCT ID: NCT03707158
Last Updated: 2025-03-27
Results Overview
This caregiver-report anxiety questionnaire is a publicly available measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response (range: 8-40), with higher scores represents higher levels of anxiety. Raw scores are converted to T-scores (range: 33.5-88.3), with higher T-scores representing higher levels of anxiety. T-scores of 50 reflect the population mean with a standard deviation of 10. Scores of 55 indicated elevated anxiety and \>=60 reflecting clinical levels of anxiety. T scores are reported here and were subjected to analyses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)
Results posted on
2025-03-27
Participant Flow
Enrollment numbers refer to # of dyads, not # of individuals--that is, a treated child and their caregiver together count as 1 enrollment. Values in table below refer to # of dyads.
Participant milestones
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Baseline
STARTED
|
156
|
149
|
|
Baseline
COMPLETED
|
156
|
149
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Midtreatment
STARTED
|
156
|
149
|
|
Midtreatment
COMPLETED
|
112
|
123
|
|
Midtreatment
NOT COMPLETED
|
44
|
26
|
|
Posttreatment
STARTED
|
112
|
123
|
|
Posttreatment
COMPLETED
|
112
|
118
|
|
Posttreatment
NOT COMPLETED
|
0
|
5
|
|
Follow-up
STARTED
|
112
|
118
|
|
Follow-up
COMPLETED
|
80
|
94
|
|
Follow-up
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Midtreatment
Lost to Follow-up
|
16
|
7
|
|
Midtreatment
Withdrawal by Subject
|
28
|
19
|
|
Posttreatment
Lost to Follow-up
|
0
|
5
|
|
Follow-up
Lost to Follow-up
|
19
|
18
|
|
Follow-up
Withdrawal by Subject
|
13
|
6
|
Baseline Characteristics
Kids FACE FEARS Comparative Effectiveness Research
Baseline characteristics by cohort
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.65 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
42.07 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
42.37 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Age, Customized
7-12 years old
|
104 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Age, Customized
13-18 years old
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Cis Male
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Cis Female
|
102 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans or NonBinary
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
133 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Reported
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine & Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine & American Indian/Alaskan Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black & Hispanic/Latine
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black & American Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black & Hispanic/Latine & American Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black & Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black & Middle Eastern/North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian & Middle Eastern/North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native & Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern or North African (MENA)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
156 participants
n=5 Participants
|
149 participants
n=7 Participants
|
305 participants
n=5 Participants
|
|
Caregiver Nativity
Caregiver U.S. Born
|
92 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Caregiver Nativity
Caregiver Foreign Born
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Household Resource Insecurity
Baseline Household Resource Insecurity
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Household Resource Insecurity
No Baseline Household Resource Insecurity
|
128 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Non-English Language Spoken in Home
Yes
|
82 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Non-English Language Spoken in Home
No
|
73 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Non-English Language Spoken in Home
Not reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Caregiver Education
High School or Less
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Caregiver Education
Completed College
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Caregiver Education
Completed Graduate School
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Caregiver Education
Not reported
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)Population: Intention-to-treat
This caregiver-report anxiety questionnaire is a publicly available measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response (range: 8-40), with higher scores represents higher levels of anxiety. Raw scores are converted to T-scores (range: 33.5-88.3), with higher T-scores representing higher levels of anxiety. T-scores of 50 reflect the population mean with a standard deviation of 10. Scores of 55 indicated elevated anxiety and \>=60 reflecting clinical levels of anxiety. T scores are reported here and were subjected to analyses.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)
Baseline
|
65.7 T-Score
Standard Deviation 8.3
|
66.0 T-Score
Standard Deviation 8.3
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)
Midtreatment
|
59.2 T-Score
Standard Deviation 9.4
|
59.1 T-Score
Standard Deviation 9.4
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)
Posttreatment
|
57.9 T-Score
Standard Deviation 9.7
|
57.7 T-Score
Standard Deviation 9.7
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)
Follow-up
|
56.2 T-Score
Standard Deviation 10.2
|
55.9 T-Score
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)Population: Intention-to-treat analyses
This youth self-report anxiety questionnaire is a publicly available measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response (range: 8-40), with higher scores represents higher levels of anxiety. Raw scores are converted to T-scores (range: 33.5-88.3), with higher T-scores representing higher levels of anxiety. T-scores of 50 reflect the population mean with a standard deviation of 10. Scores of 55 indicated elevated anxiety and \>=60 reflecting clinical levels of anxiety. T scores are reported here and were subjected to analyses.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)
Baseline
|
61.4 T scores
Standard Deviation 9.5
|
61.2 T scores
Standard Deviation 9.5
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)
Midtreatment
|
55.6 T scores
Standard Deviation 9.6
|
56.4 T scores
Standard Deviation 9.6
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)
Posttreatment
|
54.7 T scores
Standard Deviation 9.4
|
54.4 T scores
Standard Deviation 9.4
|
|
Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)
Follow-up
|
54.4 T scores
Standard Deviation 10.0
|
54.2 T scores
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)Population: Intention-to-treat analyses
The Child Anxiety Life Interference Scale (CALIS) parent-report is a measure of caregiver perceptions of life interference and impairment associated with child anxiety. The CALIS has demonstrated strong psychometric properties, and assesses impairments in family, peer, academic, and extracurricular life domains. The CALIS parent-report 16 items administered to caregivers. All items, which relate to common activities (e.g. "being with friends outside of school" or "your career choice"), are rated on a five-point Likert scale (0 = not at all, 4 = a great deal), with higher scores indicating higher anxiety life interference. Scores range from 0-64.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Child Anxiety Life Interference Scale (CALIS), Caregiver Report
Baseline
|
26.3 score on a scale
Standard Deviation 12.2
|
26.8 score on a scale
Standard Deviation 12.2
|
|
Child Anxiety Life Interference Scale (CALIS), Caregiver Report
Midtreatment
|
20.2 score on a scale
Standard Deviation 12.1
|
20.5 score on a scale
Standard Deviation 12.1
|
|
Child Anxiety Life Interference Scale (CALIS), Caregiver Report
Posttreatment
|
18.9 score on a scale
Standard Deviation 12.
|
19.3 score on a scale
Standard Deviation 12.2
|
|
Child Anxiety Life Interference Scale (CALIS), Caregiver Report
Follow-up
|
17.3 score on a scale
Standard Deviation 12.2
|
17.6 score on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)Population: Intention-to-treat analyses
The Child Anxiety Life Interference Scale (CALIS) youth-report is a measure of youth self-reports of life interference and impairment associated with child anxiety. The CALIS has demonstrated strong psychometric properties, and assesses impairments in family, peer, academic, and extracurricular life domains. The CALIS youth self-report 9 items. All items, which relate to common activities (e.g. "being with friends outside of school" or "your career choice"), are rated on a five-point Likert scale (0 = not at all, 4 = a great deal), with higher scores indicating higher anxiety life interference. Scores range from 0-36.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Child Anxiety Life Interference Scale (CALIS), Youth Self-Report
Baseline
|
13.1 score on a scale
Standard Deviation 7.5
|
13.4 score on a scale
Standard Deviation 7.5
|
|
Child Anxiety Life Interference Scale (CALIS), Youth Self-Report
Midtreatment
|
10.6 score on a scale
Standard Deviation 7.1
|
11.1 score on a scale
Standard Deviation 7.1
|
|
Child Anxiety Life Interference Scale (CALIS), Youth Self-Report
Posttreatment
|
10.6 score on a scale
Standard Deviation 7.5
|
10.1 score on a scale
Standard Deviation 7.5
|
|
Child Anxiety Life Interference Scale (CALIS), Youth Self-Report
Follow-up
|
9.5 score on a scale
Standard Deviation 8.1
|
10.0 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
To assess Caregivers Treatment Satisfaction, caregivers were administered a Satisfaction Scale that had them rate three items along 0-3 rating scales at at posttreatment: "Overall, how satisfied \[have you been/were you\] with the services that your family received?" \[0=quite dissatisfied; 3=very satisfied\]; "Would you recommend this program to a friend if they had a child with anxiety?" \[0=no, definitely not; 3=yes, definitely\]; and "How pleased \[have you been/were you\] with how this program has helped your child with anxiety" \[0=quite displeased; 3=very pleased\]. These three items were averaged for each informant to generate a Caregiver Total Satisfaction Score (range: 0-3, higher scores reflect greater satisfaction).
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Caregiver Treatment Satisfaction (Continuously Scored)
|
2.2 score on a scale
Standard Deviation 0.7
|
2.7 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat
At posttreatment caregivers were asked to rate three items developed for the present trial along 0-3 rating scales: "Overall, how satisfied were you with the services that your family received?" \[0=quite dissatisfied; 3=very satisfied\]; "Would you recommend this program to a friend if they had a child with anxiety?" \[0=no, definitely not; 3=yes, definitely\]; and "How pleased were you with how this program helped your child with anxiety" \[0=quite displeased; 3=very pleased\]. These items were averaged for each informant to generate a Caregiver Total Satisfaction Score (range: 0-3, higher scores reflect greater treatment satisfaction). For interpretation, mean scores \<2 were interpreted as "Dissatisfied." Here we present the % of "Dissatisfied" caregivers at Post, across conditions.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Caregiver Treatment Dissatisfaction (% of "Dissatisfied" Caregivers, Based on Dichotomous Coding of Dissatisfaction)
|
23.9 percentage of caregivers
|
6.8 percentage of caregivers
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
To assess Youth Treatment Satisfaction, youth \> 8 years were administered a Satisfaction Scale that had them rate three items along 0-3 rating scales at posttreatment: "Overall, how satisfied \[have you been/were you\] with the services that you received?" \[0=quite dissatisfied; 3=very satisfied\]; "Would you recommend this program to a friend if they had anxiety?" \[0=no, definitely not; 3=yes, definitely\]; and "How pleased \[have you been/were you\] with how this program has helped you with anxiety" \[0=quite displeased; 3=very pleased\]. These three items were averaged for each informant to generate a Youth Total Satisfaction Score (range: 0-3, higher scores reflect greater satisfaction).
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Youth Treatment Satisfaction (Continuously Scored)
|
2.1 score on a scale
Standard Deviation .8
|
2.4 score on a scale
Standard Deviation .8
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat
At posttreatment, youth were asked to rate three items developed for the present trial along 0-3 rating scales: "Overall, how satisfied were you with the services that you received?" \[0=quite dissatisfied; 3=very satisfied\]; "Would you recommend this program to a friend if they had anxiety?" \[0=no, definitely not; 3=yes, definitely\]; and "How pleased were you with how this program helped your anxiety" \[0=quite displeased; 3=very pleased\]. These items were averaged for each informant to generate a Youth Total Satisfaction Score (range: 0-3, higher scores reflect greater treatment satisfaction). For interpretation, mean scores \<2 were interpreted as "Dissatisfied." Here we present the % of "Dissatisfied" youth at Post, across conditions.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Youth Treatment Dissatisfaction (% of "Dissatisfied" Youth, Based on Dichotomous Coding of Dissatisfaction)
|
33.3 percentage of youth
|
19.9 percentage of youth
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
To assess Caregiver-Perceived Effectiveness, caregivers were asked on a 7-point scale "How effective do you think the program \[has been/was\] in treating your child's anxiety?" \[0=very ineffective; 3=somewhat effective; 6=very effective\]. Range of possible scores: 0-42; higher scores reflect greater perceived effectiveness.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Caregiver-Perceived Effectiveness
|
2.9 score on a scale
Standard Deviation 1.8
|
4.2 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat
"Treatment Responder" defined as score reduction of at least 35% on the Pediatric Rating Scale (PARS). The PARS is a well-established clinician-rated instrument for assessing the frequency and severity of anxiety symptoms. Six global items are summed to generate a PARS Total score. The PARS has shown strong psychometric properties. PARS Total Score reductions of 35% or more are empirically defined as reflecting "Treatment Response". For the present study, PARS interviews were conducted by independent evaluators masked to treatment condition. Values here reflect the % of "Treatment Responders" at post, across conditions
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Rate of Treatment Responders (% of Children Whose Posttreatment PARS Score Was at Least 35% Less Than Their Baseline PARS Score)
|
48.7 percentage of children
|
55.4 percentage of children
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat
Therapists completed weekly logs reporting whether study families on their caseloads completed the homework assigned in their previous session or support call. Homework completion reflects the percent of weeks across the trial in which all assigned homework was completed by caregiver, accounting for nesting and for covariates.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework)
|
53.1 percentage of trial weeks
|
70.7 percentage of trial weeks
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat
Therapists completed weekly logs reporting whether study families on their caseloads completed the homework assigned in their previous session or support call. Homework completion reflects the percent of weeks across the trial in which all assigned homework was completed by child/teen, accounting for nesting and for covariates.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework)
|
50.8 percentage of trial weeks
|
61.9 percentage of trial weeks
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Therapists completed weekly logs reporting whether study families on their caseloads attended their scheduled sessions. Treatment Completion was defined for Therapist-Led CBT as attending 10 treatment sessions, and for Guided Online CBT Care as attending 4 support calls. For Guided Online CBT families, administrative backend data was also collected from the central server to further assess user/usage analytics. Values reflect % of completers within each condition.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=156 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=149 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Treatment Completion (% of Children Who Completed Their Treatment Program)
|
53.2 percentage of children
|
46.3 percentage of children
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
Caregivers were asked at Posttreatment "How hard has the intervention been for \[your family/your child\] and you to understand?" \[0=never hard; 3=sometimes hard; 6=very hard\]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater comprehension difficulties.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Treatment Comprehension Difficulties (Caregiver Report)
|
1.67 units on a scale
Standard Deviation 1.5
|
1.01 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
To assess Difficulties Making Time for Treatment caregivers were asked at at Posttreatment "How hard has it been for \[your family/your child\] to \[make your schedule work for treatment sessions/find time to work on and complete the computer-based treatment modules online\]?" \[0=never a problem; 3=sometimes a problem; 6=often a problem\]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater difficulties making time for treatment.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Difficulty Making Time for Treatment (Caregiver Report)
|
3.17 units on a scale
Standard Deviation 2.1
|
2.14 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Posttreatment (on average, 19 weeks)Population: Intention-to-Treat model means
Caregivers were asked at Posttreatment "How comfortable has your \[family/child\] felt when \[attending treatment sessions/completing the computer-based treatment modules online\]?" \[0=very comfortable; 3=sometimes comfortable; 6=very uncomfortable\]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater treatment discomfort.
Outcome measures
| Measure |
Guided Online CBT (With Minimal Therapist Involvement)
n=112 Participants
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)
Guided Online CBT: Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
n=118 Participants
The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.
Therapist-Led CBT (telehealth, office-based, or hybrid): Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
|
|---|---|---|
|
Treatment Discomfort (Caregiver Report)
|
2.81 units on a scale
Standard Deviation 2.2
|
2.86 units on a scale
Standard Deviation 2.6
|
Adverse Events
Guided Online CBT (With Minimal Therapist Involvement)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)
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