A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT01653288
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), The University of Queensland (Other)
72
1
2
36
2
Study Details
Study Description
Brief Summary
This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered online to children who have experience an acute medical event.
The core study hypotheses are that children receiving the intervention will (1) endorse fewer maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up, and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health related quality of life (HRQOL) at 12 week follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to evaluate the feasibility and provide an initial evaluation of the efficacy of Coping Coach, a new web-based intervention for children experiencing acute medical events.
The study aims to (1) assess and maximize intervention feasibility, (2) conduct an initial efficacy testing (pilot RCT) for proximal outcomes (appraisals, coping) and subsequent child health outcomes (PTS reactions, HRQOL), and (3) refine the conceptual framework and optimize the intervention effectiveness.
Study Design:
This study will progress in multiple stages:
Pilot study: 20 children experiencing a potentially traumatic medical event will be given the Coping Coach intervention with follow-up at 6 weeks. This pilot will examine initial feasibility, usability, acceptability, and child engagement/ comprehension of the intervention.
Additional Pilot Study (2015): 20 children treated in the ED or admitted to the hospital with injury due to non-family violence will be provided with the Coping Coach intervention. Other inclusion and exclusion criteria, as well as baseline, 6- and 12-week assessments parallel those from the RCT stage described below. This pilot will examine feasibility, engagement, and estimate pre-post changes in key measures in children with violence exposure.
RCT: A wait-list design will compare intervention use with a waitlist control on proximal and child health outcomes at 6, 12, and 18 weeks after baseline enrollment. The Coping Coach intervention will be provided to the waitlist control after the 12 week assessment. 70 children will be enrolled, 35 in each arm. (Assessment of feasibility and engagement will continue in this stage.)
The rest of this CLINICALTRIALS.GOV record describes the RCT (N=72).
The Pilot and RCT combined will help us prepare for rigorous large-scale RCT of Coping Coach.
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Study Start Date
:
Mar 1, 2013
Actual Primary Completion Date
:
Mar 1, 2016
Actual Study Completion Date
:
Mar 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Coping Coach Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. |
Behavioral: 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.
|
| Experimental: Coping Coach Waitlist Control Treatment as usual from baseline to 12 week follow-up assessment. Then receive access to Coping Coach intervention after 12 week follow-up for use (self-guided, with email reminders) over the next 6 weeks. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility of the Coping Coach Online Intervention [6 weeks]
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.
- Mean Time Spent Using the Intervention [6 weeks]
Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Secondary Outcome Measures
- a Preliminary Assessment of the Efficacy of the Intervention [6 weeks]
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.
- a Preliminary Assessment of the Efficacy of the Intervention [12 weeks]
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.
Other Outcome Measures
- Preliminary Assessment of Efficacy of Later Use of the Intervention [18 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
8 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is 8 to 12 years of age
-
Child has experienced a potentially traumatic medical event* within the past 2 weeks
-
Child's GCS > 12
-
Child speaks English well enough to complete the measures and participate in an interview
-
Child has access to the Internet and telephone
-
Parental/legal guardian informed consent and child assent
Exclusion Criteria:
-
Child's current medical condition or cognitive limitations preclude participating in an interview
-
Child's acute medical event is due to family violence or suspected child abuse
-
Child or parent has been arrested or is subject to legal proceedings related to the index incident
-
In the index event, child or parent was a perpetrator of violence (or participant in mutual violence)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- The University of Queensland
Investigators
- Principal Investigator: Nancy Kassam-Adams, PhD, Center for Injury Research & Prevention, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01653288
Other Study ID Numbers:
- 12-009336
- 1R21HD069832-01A1
First Posted:
Jul 31, 2012
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Coping Coach | Coping Coach Waitlist Control |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Coping Coach | Coping Coach Waitlist Control | Total |
|---|---|---|---|
| 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 Participants | 36 | 36 | 72 |
| Age (Count of Participants) | |||
| <=18 years |
36
100%
|
36
100%
|
72
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.8
(1.5)
|
9.8
(1.3)
|
9.8
(1.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
41.7%
|
18
50%
|
33
45.8%
|
| Male |
21
58.3%
|
18
50%
|
39
54.2%
|
| Race/Ethnicity, Customized (Count of 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%
|
3
4.2%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
36
100%
|
36
100%
|
72
100%
|
| Parent education (Count of 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%
|
21
58.3%
|
30
41.7%
|
| Annual household income (Count of 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%
|
1
1.4%
|
| Type of acute medical event experienced by child (Count of Participants) | |||
| Appendicitis |
13
36.1%
|
18
50%
|
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%
|
6
16.7%
|
15
20.8%
|
| Injury |
6
16.7%
|
4
11.1%
|
10
13.9%
|
| Child's prior trauma exposure (Count of Participants) | |||
| yes |
27
75%
|
25
69.4%
|
52
72.2%
|
| no |
9
25%
|
11
30.6%
|
20
27.8%
|
| yes |
7
19.4%
|
3
8.3%
|
10
13.9%
|
| no |
29
80.6%
|
33
91.7%
|
62
86.1%
|
| yes |
27
75%
|
24
66.7%
|
51
70.8%
|
| no |
9
25%
|
12
33.3%
|
21
29.2%
|
| Baseline stats for outcome measures (units on a scale) [Mean (Standard Deviation) ] | |||
| 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)
|
Outcome Measures
| Title | Feasibility of the Coping Coach Online Intervention |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 36 | 28 |
| yes |
35
97.2%
|
19
52.8%
|
| no |
1
2.8%
|
9
25%
|
| yes |
19
52.8%
|
15
41.7%
|
| no |
17
47.2%
|
13
36.1%
|
| Title | Mean Time Spent Using the Intervention |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 36 | 28 |
| Mean (Standard Deviation) [minutes] |
52.2
(36.9)
|
51.5
(30.7)
|
| Title | a Preliminary Assessment of the Efficacy of the Intervention |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 24 | 34 |
| 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)
|
| Title | a Preliminary Assessment of the Efficacy of the Intervention |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 22 | 28 |
| 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)
|
| Title | Preliminary Assessment of Efficacy of Later Use of the Intervention |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 20 | 31 |
| 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)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Coping Coach | Coping Coach Waitlist Control | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Coping Coach | Coping Coach Waitlist Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/36 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Coping Coach | Coping Coach Waitlist Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/36 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Dr. Nancy Kassam-Adams |
|---|---|
| Organization | Children's Hospital of Philadelphia |
| Phone | 2155903118 |
| adamsn@email.chop.edu |
Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01653288
Other Study ID Numbers:
- 12-009336
- 1R21HD069832-01A1
First Posted:
Jul 31, 2012
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019