Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of "Coping Coach," a Web-based Preventive Intervention for Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01653288
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Queensland
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Stress Disorders, Post Traumatic
Intervention Behavioral: Coping Coach
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 36 36
Completed 26 35
Not Completed 10 1
Arm/Group Title Coping Coach Coping Coach Waitlist Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
<=18 years
36
 100.0%
36
 100.0%
72
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
9.8  (1.5) 9.8  (1.3) 9.8  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
15
  41.7%
18
  50.0%
33
  45.8%
Male
21
  58.3%
18
  50.0%
39
  54.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Child race / ethnicity Number Analyzed 36 participants 36 participants 72 participants
Black
12
  33.3%
12
  33.3%
24
  33.3%
White
21
  58.3%
24
  66.7%
45
  62.5%
Other race / ethnicity
3
   8.3%
0
   0.0%
3
   4.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 36 participants 72 participants
36
 100.0%
36
 100.0%
72
 100.0%
Parent education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Attended or completed high school
7
  19.4%
7
  19.4%
14
  19.4%
Attended college
20
  55.6%
8
  22.2%
28
  38.9%
Completed college or graduate degree
9
  25.0%
21
  58.3%
30
  41.7%
Annual household income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
less than $30K
10
  27.8%
6
  16.7%
16
  22.2%
$30K to less than $50K
8
  22.2%
7
  19.4%
15
  20.8%
$50K to less than $75K
4
  11.1%
4
  11.1%
8
  11.1%
$75K to less than $100K
5
  13.9%
4
  11.1%
9
  12.5%
$100K or more
8
  22.2%
15
  41.7%
23
  31.9%
Not reported
1
   2.8%
0
   0.0%
1
   1.4%
Type of acute medical event experienced by child  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Appendicitis
13
  36.1%
18
  50.0%
31
  43.1%
Asthma-related
4
  11.1%
2
   5.6%
6
   8.3%
Abdominal pain
3
   8.3%
3
   8.3%
6
   8.3%
Acute joint pain or arthritis
1
   2.8%
3
   8.3%
4
   5.6%
Other acute medical illness
9
  25.0%
6
  16.7%
15
  20.8%
Injury
6
  16.7%
4
  11.1%
10
  13.9%
Child's prior trauma exposure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Any prior trauma yes
27
  75.0%
25
  69.4%
52
  72.2%
no
9
  25.0%
11
  30.6%
20
  27.8%
Prior interpersonal trauma yes
7
  19.4%
3
   8.3%
10
  13.9%
no
29
  80.6%
33
  91.7%
62
  86.1%
Prior non-interpersonal trauma yes
27
  75.0%
24
  66.7%
51
  70.8%
no
9
  25.0%
12
  33.3%
21
  29.2%
Baseline stats for outcome measures   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 36 participants 72 participants
mean (SD) CPTCI score - maladaptive appraisals 45.4  (12.1) 40.5  (11.6) 43.0  (12.0)
mean (SD) HICUPS score - avoidance coping) 32.4  (7.3) 29.3  (7.4) 30.9  (7.5)
mean (SD) CPSS score - traumatic stress severity 18.4  (11.8) 13.3  (7.3) 15.6  (10.1)
mean (SD) PedsQL score - health quality of life 78.0  (17.3) 82.1  (15.8) 79.9  (16.6)
[1]
Measure Description:

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.

1.Primary Outcome
Title Feasibility of the Coping Coach Online Intervention
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 28
Measure Type: Count of Participants
Unit of Measure: Participants
Logged in / used intervention at least once yes
35
  97.2%
19
  67.9%
no
1
   2.8%
9
  32.1%
Completed entire online intervention yes
19
  52.8%
15
  53.6%
no
17
  47.2%
13
  46.4%
2.Primary Outcome
Title Mean Time Spent Using the Intervention
Hide Description Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 28
Mean (Standard Deviation)
Unit of Measure: minutes
52.2  (36.9) 51.5  (30.7)
3.Secondary Outcome
Title a Preliminary Assessment of the Efficacy of the Intervention
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
descriptive statistics for all randomized participants who completed these measures at 6 week follow-up
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 24 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
mean (SD) CPTCI score - maladaptive appraisals 45.9  (10.6) 43.8  (10.5)
mean (SD) HICUPS score - avoidance coping 35.4  (7.9) 31.7  (5.9)
mean (SD) CPSS score - traumatic stress severity 13.0  (12.1) 12.5  (10.0)
mean (SD) PedsQL score - health quality of life 75.1  (19.1) 81.4  (17.5)
4.Secondary Outcome
Title a Preliminary Assessment of the Efficacy of the Intervention
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
descriptive statistics for all randomized participants who completed these measures at 12 week follow-up
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
mean (SD) - CPTCI score - maladaptive appraisals 39.3  (9.0) 41.3  (11.5)
mean (SD) HICUPS score - avoidance coping 30.6  (9.8) 31.7  (5.7)
mean (SD) CPSS score - traumatic stress severity 13.9  (14.3) 14.6  (12.0)
mean (SD) PedsQL score - health quality of life 86.8  (18.3) 85.1  (15.1)
5.Other Pre-specified Outcome
Title Preliminary Assessment of Efficacy of Later Use of the Intervention
Hide Description

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.

Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 20 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
mean (SD) CPTCI score - maladaptive appraisals 40.8  (12.6) 41.1  (11.8)
mean (SD) HICUPS score - avoidance coping 33.0  (7.6) 31.4  (6.9)
mean (SD) CPSS score - traumatic stress severity 15.3  (12.5) 11.0  (10.4)
mean (SD) PedsQL score - health quality of life 78.5  (23.4) 90.4  (11.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coping Coach Coping Coach Waitlist Control
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Coping Coach Coping Coach Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Coping Coach Coping Coach Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coping Coach Coping Coach Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nancy Kassam-Adams
Organization: Children's Hospital of Philadelphia
Phone: 2155903118
EMail: adamsn@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01653288    
Other Study ID Numbers: 12-009336
1R21HD069832-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2012
First Posted: July 31, 2012
Results First Submitted: February 14, 2018
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019