Trial Outcomes & Findings for A Trial of "Coping Coach," a Web-based Preventive Intervention for Children (NCT NCT01653288)
NCT ID: NCT01653288
Last Updated: 2019-02-26
Results Overview
Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Coping Coach
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
|
Coping Coach Waitlist Control
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
26
|
35
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Baseline characteristics by cohort
| Measure |
Coping Coach
n=36 Participants
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
|
Coping Coach Waitlist Control
n=36 Participants
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
Coping Coach: Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
9.8 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
9.8 years
STANDARD_DEVIATION 1.3 • n=4 Participants
|
9.8 years
STANDARD_DEVIATION 1.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Child race / ethnicity · Black
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Child race / ethnicity · White
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Child race / ethnicity · Other race / ethnicity
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Parent education
Attended or completed high school
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Parent education
Attended college
|
20 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Parent education
Completed college or graduate degree
|
9 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Annual household income
less than $30K
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Annual household income
$30K to less than $50K
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Annual household income
$50K to less than $75K
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Annual household income
$75K to less than $100K
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Annual household income
$100K or more
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Annual household income
Not reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Appendicitis
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Asthma-related
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Abdominal pain
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Acute joint pain or arthritis
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Other acute medical illness
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Type of acute medical event experienced by child
Injury
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Any prior trauma · yes
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Any prior trauma · no
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Prior interpersonal trauma · yes
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Prior interpersonal trauma · no
|
29 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Prior non-interpersonal trauma · yes
|
27 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Child's prior trauma exposure
Prior non-interpersonal trauma · no
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Baseline stats for outcome measures
mean (SD) CPTCI score - maladaptive appraisals
|
45.4 units on a scale
STANDARD_DEVIATION 12.1 • n=93 Participants
|
40.5 units on a scale
STANDARD_DEVIATION 11.6 • n=4 Participants
|
43.0 units on a scale
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Baseline stats for outcome measures
mean (SD) HICUPS score - avoidance coping)
|
32.4 units on a scale
STANDARD_DEVIATION 7.3 • n=93 Participants
|
29.3 units on a scale
STANDARD_DEVIATION 7.4 • n=4 Participants
|
30.9 units on a scale
STANDARD_DEVIATION 7.5 • n=27 Participants
|
|
Baseline stats for outcome measures
mean (SD) CPSS score - traumatic stress severity
|
18.4 units on a scale
STANDARD_DEVIATION 11.8 • n=93 Participants
|
13.3 units on a scale
STANDARD_DEVIATION 7.3 • n=4 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
Baseline stats for outcome measures
mean (SD) PedsQL score - health quality of life
|
78.0 units on a scale
STANDARD_DEVIATION 17.3 • n=93 Participants
|
82.1 units on a scale
STANDARD_DEVIATION 15.8 • n=4 Participants
|
79.9 units on a scale
STANDARD_DEVIATION 16.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Analyzing usage among all participants who received access (i.e. information on how to sign in) to the Coping Coach online intervention. 28 of 36 in the waitlist control condition completed a 12 week research assessment and then received sign-in information.
Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.
Outcome measures
| Measure |
Coping Coach
n=36 Participants
Usage data reported for baseline to week 6
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
|
Coping Coach Waitlist Control
n=28 Participants
Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
|
|---|---|---|
|
Feasibility of the Coping Coach Online Intervention
Logged in / used intervention at least once · yes
|
35 Participants
|
19 Participants
|
|
Feasibility of the Coping Coach Online Intervention
Logged in / used intervention at least once · no
|
1 Participants
|
9 Participants
|
|
Feasibility of the Coping Coach Online Intervention
Completed entire online intervention · yes
|
19 Participants
|
15 Participants
|
|
Feasibility of the Coping Coach Online Intervention
Completed entire online intervention · no
|
17 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Analyzing usage among all participants who received access (i.e. information on how to sign in) to the Coping Coach online intervention. 28 of 36 in the waitlist control condition completed a 12 week research assessment and then received sign-in information.
Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Outcome measures
| Measure |
Coping Coach
n=36 Participants
Usage data reported for baseline to week 6
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
|
Coping Coach Waitlist Control
n=28 Participants
Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
|
|---|---|---|
|
Mean Time Spent Using the Intervention
|
52.2 minutes
Standard Deviation 36.9
|
51.5 minutes
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: descriptive statistics for all randomized participants who completed these measures at 6 week follow-up
Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe. Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life. How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping. Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals.
Outcome measures
| Measure |
Coping Coach
n=24 Participants
Usage data reported for baseline to week 6
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
|
Coping Coach Waitlist Control
n=34 Participants
Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
|
|---|---|---|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) CPTCI score - maladaptive appraisals
|
45.9 units on a scale
Standard Deviation 10.6
|
43.8 units on a scale
Standard Deviation 10.5
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) HICUPS score - avoidance coping
|
35.4 units on a scale
Standard Deviation 7.9
|
31.7 units on a scale
Standard Deviation 5.9
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) CPSS score - traumatic stress severity
|
13.0 units on a scale
Standard Deviation 12.1
|
12.5 units on a scale
Standard Deviation 10.0
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) PedsQL score - health quality of life
|
75.1 units on a scale
Standard Deviation 19.1
|
81.4 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: descriptive statistics for all randomized participants who completed these measures at 12 week follow-up
Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe. Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life. How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping. Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals.
Outcome measures
| Measure |
Coping Coach
n=22 Participants
Usage data reported for baseline to week 6
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
|
Coping Coach Waitlist Control
n=28 Participants
Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
|
|---|---|---|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) - CPTCI score - maladaptive appraisals
|
39.3 units on a scale
Standard Deviation 9.0
|
41.3 units on a scale
Standard Deviation 11.5
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) HICUPS score - avoidance coping
|
30.6 units on a scale
Standard Deviation 9.8
|
31.7 units on a scale
Standard Deviation 5.7
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) CPSS score - traumatic stress severity
|
13.9 units on a scale
Standard Deviation 14.3
|
14.6 units on a scale
Standard Deviation 12.0
|
|
a Preliminary Assessment of the Efficacy of the Intervention
mean (SD) PedsQL score - health quality of life
|
86.8 units on a scale
Standard Deviation 18.3
|
85.1 units on a scale
Standard Deviation 15.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 weeksPopulation: reporting on all participants who completed follow-up measures at 18 week. Note that at 12 weeks, those in the waitlist control group who completed the 12 week research assessment (N=28) were given access to the online intervention
Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe. Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life. How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping. Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals.
Outcome measures
| Measure |
Coping Coach
n=20 Participants
Usage data reported for baseline to week 6
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
|
Coping Coach Waitlist Control
n=31 Participants
Usage data reported for weeks 12 to 18 (i.e when this arm had access to the online intervention)
Treatment as usual till 12 wk assessment, then access to Coping Coach intervention for use (self-guided, email reminders) over next 6 wks.
|
|---|---|---|
|
Preliminary Assessment of Efficacy of Later Use of the Intervention
mean (SD) CPTCI score - maladaptive appraisals
|
40.8 units on a scale
Standard Deviation 12.6
|
41.1 units on a scale
Standard Deviation 11.8
|
|
Preliminary Assessment of Efficacy of Later Use of the Intervention
mean (SD) HICUPS score - avoidance coping
|
33.0 units on a scale
Standard Deviation 7.6
|
31.4 units on a scale
Standard Deviation 6.9
|
|
Preliminary Assessment of Efficacy of Later Use of the Intervention
mean (SD) CPSS score - traumatic stress severity
|
15.3 units on a scale
Standard Deviation 12.5
|
11.0 units on a scale
Standard Deviation 10.4
|
|
Preliminary Assessment of Efficacy of Later Use of the Intervention
mean (SD) PedsQL score - health quality of life
|
78.5 units on a scale
Standard Deviation 23.4
|
90.4 units on a scale
Standard Deviation 11.2
|
Adverse Events
Coping Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coping Coach Waitlist Control
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
Dr. Nancy Kassam-Adams
Children's Hospital of Philadelphia
Phone: 2155903118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place