Stress Disorders, Post Traumatic
Conditions
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.
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.
Interventions
BEHAVIORALCoping 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Queensland
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Coping Coach Waitlist Control | Coping Coach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.8 years STANDARD_DEVIATION 1.3 | 9.8 years STANDARD_DEVIATION 1.5 | 9.8 years STANDARD_DEVIATION 1.4 |
| Annual household income $100K or more | 15 Participants | 8 Participants | 23 Participants |
| Annual household income $30K to less than $50K | 7 Participants | 8 Participants | 15 Participants |
| Annual household income $50K to less than $75K | 4 Participants | 4 Participants | 8 Participants |
| Annual household income $75K to less than $100K | 4 Participants | 5 Participants | 9 Participants |
| Annual household income less than $30K | 6 Participants | 10 Participants | 16 Participants |
| Annual household income Not reported | 0 Participants | 1 Participants | 1 Participants |
| Baseline stats for outcome measures mean (SD) CPSS score - traumatic stress severity | 13.3 units on a scale STANDARD_DEVIATION 7.3 | 18.4 units on a scale STANDARD_DEVIATION 11.8 | 15.6 units on a scale STANDARD_DEVIATION 10.1 |
| Baseline stats for outcome measures mean (SD) CPTCI score - maladaptive appraisals | 40.5 units on a scale STANDARD_DEVIATION 11.6 | 45.4 units on a scale STANDARD_DEVIATION 12.1 | 43.0 units on a scale STANDARD_DEVIATION 12 |
| Baseline stats for outcome measures mean (SD) HICUPS score - avoidance coping) | 29.3 units on a scale STANDARD_DEVIATION 7.4 | 32.4 units on a scale STANDARD_DEVIATION 7.3 | 30.9 units on a scale STANDARD_DEVIATION 7.5 |
| Baseline stats for outcome measures mean (SD) PedsQL score - health quality of life | 82.1 units on a scale STANDARD_DEVIATION 15.8 | 78.0 units on a scale STANDARD_DEVIATION 17.3 | 79.9 units on a scale STANDARD_DEVIATION 16.6 |
| Child's prior trauma exposure Any prior trauma no | 11 Participants | 9 Participants | 20 Participants |
| Child's prior trauma exposure Any prior trauma yes | 25 Participants | 27 Participants | 52 Participants |
| Child's prior trauma exposure Prior interpersonal trauma no | 33 Participants | 29 Participants | 62 Participants |
| Child's prior trauma exposure Prior interpersonal trauma yes | 3 Participants | 7 Participants | 10 Participants |
| Child's prior trauma exposure Prior non-interpersonal trauma no | 12 Participants | 9 Participants | 21 Participants |
| Child's prior trauma exposure Prior non-interpersonal trauma yes | 24 Participants | 27 Participants | 51 Participants |
| Parent education Attended college | 8 Participants | 20 Participants | 28 Participants |
| Parent education Attended or completed high school | 7 Participants | 7 Participants | 14 Participants |
| Parent education Completed college or graduate degree | 21 Participants | 9 Participants | 30 Participants |
| Race/Ethnicity, Customized Child race / ethnicity Black | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Child race / ethnicity Other race / ethnicity | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Child race / ethnicity White | 24 Participants | 21 Participants | 45 Participants |
| Region of Enrollment United States | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 18 Participants | 21 Participants | 39 Participants |
| Type of acute medical event experienced by child Abdominal pain | 3 Participants | 3 Participants | 6 Participants |
| Type of acute medical event experienced by child Acute joint pain or arthritis | 3 Participants | 1 Participants | 4 Participants |
| Type of acute medical event experienced by child Appendicitis | 18 Participants | 13 Participants | 31 Participants |
| Type of acute medical event experienced by child Asthma-related | 2 Participants | 4 Participants | 6 Participants |
| Type of acute medical event experienced by child Injury | 4 Participants | 6 Participants | 10 Participants |
| Type of acute medical event experienced by child Other acute medical illness | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
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.
Time frame: 6 weeks
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Coping Coach | Feasibility of the Coping Coach Online Intervention | Logged in / used intervention at least once | no | 1 Participants |
| Coping Coach | Feasibility of the Coping Coach Online Intervention | Logged in / used intervention at least once | yes | 35 Participants |
| Coping Coach | Feasibility of the Coping Coach Online Intervention | Completed entire online intervention | yes | 19 Participants |
| Coping Coach | Feasibility of the Coping Coach Online Intervention | Completed entire online intervention | no | 17 Participants |
| Coping Coach Waitlist Control | Feasibility of the Coping Coach Online Intervention | Completed entire online intervention | no | 13 Participants |
| Coping Coach Waitlist Control | Feasibility of the Coping Coach Online Intervention | Completed entire online intervention | yes | 15 Participants |
| Coping Coach Waitlist Control | Feasibility of the Coping Coach Online Intervention | Logged in / used intervention at least once | yes | 19 Participants |
| Coping Coach Waitlist Control | Feasibility of the Coping Coach Online Intervention | Logged in / used intervention at least once | no | 9 Participants |
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.
Time frame: 6 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coping Coach | Mean Time Spent Using the Intervention | 52.2 minutes | Standard Deviation 36.9 |
| Coping Coach Waitlist Control | Mean Time Spent Using the Intervention | 51.5 minutes | Standard Deviation 30.7 |
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.
Time frame: 6 weeks
Population: descriptive statistics for all randomized participants who completed these measures at 6 week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) PedsQL score - health quality of life | 81.4 units on a scale | Standard Deviation 17.5 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) CPTCI score - maladaptive appraisals | 43.8 units on a scale | Standard Deviation 10.5 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) CPSS score - traumatic stress severity | 12.5 units on a scale | Standard Deviation 10 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) HICUPS score - avoidance coping | 31.7 units on a scale | Standard Deviation 5.9 |
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.
Time frame: 12 weeks
Population: descriptive statistics for all randomized participants who completed these measures at 12 week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Coach | 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 |
| Coping Coach | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) - CPTCI score - maladaptive appraisals | 39.3 units on a scale | Standard Deviation 9 |
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) PedsQL score - health quality of life | 85.1 units on a scale | Standard Deviation 15.1 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) - CPTCI score - maladaptive appraisals | 41.3 units on a scale | Standard Deviation 11.5 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) HICUPS score - avoidance coping | 31.7 units on a scale | Standard Deviation 5.7 |
| Coping Coach Waitlist Control | a Preliminary Assessment of the Efficacy of the Intervention | mean (SD) CPSS score - traumatic stress severity | 14.6 units on a scale | Standard Deviation 12 |
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.
Time frame: 18 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach | 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 |
| Coping Coach Waitlist Control | Preliminary Assessment of Efficacy of Later Use of the Intervention | mean (SD) PedsQL score - health quality of life | 90.4 units on a scale | Standard Deviation 11.2 |
| Coping Coach Waitlist Control | Preliminary Assessment of Efficacy of Later Use of the Intervention | mean (SD) CPTCI score - maladaptive appraisals | 41.1 units on a scale | Standard Deviation 11.8 |
| Coping Coach Waitlist Control | Preliminary Assessment of Efficacy of Later Use of the Intervention | mean (SD) CPSS score - traumatic stress severity | 11.0 units on a scale | Standard Deviation 10.4 |
| Coping Coach Waitlist Control | Preliminary Assessment of Efficacy of Later Use of the Intervention | mean (SD) HICUPS score - avoidance coping | 31.4 units on a scale | Standard Deviation 6.9 |