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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD069832-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| The University of Queensland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping Coach | Experimental | Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. |
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| Coping Coach Waitlist Control | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Coach | Behavioral | 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 | Description | Time Frame |
|---|---|---|
| Feasibility of the Coping Coach Online Intervention | 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. | 6 weeks |
| Mean Time Spent Using the Intervention | Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| a Preliminary Assessment of the Efficacy of the 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Assessment of Efficacy of Later Use of the 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Kassam-Adams, PhD | Center for Injury Research & Prevention, Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26089554 | Derived | Kassam-Adams N, Marsac ML, Kohser KL, Kenardy J, March S, Winston FK. Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events. J Pediatr Psychol. 2016 Jan-Feb;41(1):138-48. doi: 10.1093/jpepsy/jsv057. Epub 2015 Jun 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Coping Coach Online Intervention | 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. | 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. | Posted | Count of Participants | Participants | 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy Kassam-Adams | Children's Hospital of Philadelphia | 2155903118 | adamsn@email.chop.edu |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 6 weeks |
| a Preliminary Assessment of the Efficacy of the 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. | 12 weeks |
| 18 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Parent education | Count of Participants | Participants |
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| Annual household income | Count of Participants | Participants |
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| Type of acute medical event experienced by child | Count of Participants | Participants |
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| Child's prior trauma exposure | Count of Participants | Participants |
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| Baseline stats for outcome measures | 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. | Mean | Standard Deviation | units on a scale |
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| Coping Coach Waitlist Control |
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. |
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| Primary | Mean Time Spent Using the Intervention | Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here. | 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. | Posted | Mean | Standard Deviation | minutes | 6 weeks |
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| Secondary | a Preliminary Assessment of the Efficacy of the 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. | descriptive statistics for all randomized participants who completed these measures at 6 week follow-up | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
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| Secondary | a Preliminary Assessment of the Efficacy of the 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. | descriptive statistics for all randomized participants who completed these measures at 12 week follow-up | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Other Pre-specified | Preliminary Assessment of Efficacy of Later Use of the 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | 18 weeks |
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| 0 |
| 36 |
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| 36 |
| EG001 | 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. | 0 | 36 | 0 | 36 |
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| mean (SD) CPSS score - traumatic stress severity |
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| mean (SD) PedsQL score - health quality of life |
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| mean (SD) CPSS score - traumatic stress severity |
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| mean (SD) PedsQL score - health quality of life |
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| mean (SD) CPSS score - traumatic stress severity |
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| mean (SD) PedsQL score - health quality of life |
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