Stress Disorders, Post TraumaticNCT01653288
A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
A study testing Coping Coach in people with Stress Disorders, Post Traumatic, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Stress Disorders, Post Traumatic
- What is being tested?
- Coping Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
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.
Read the 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.
- Conditions
- Stress Disorders, Post Traumatic
- Being tested
- Coping Coach
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping CoachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coping Coach | Experimental | Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. Receives: Behavioral: Coping Coach |
| 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. Receives: Behavioral: Coping Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post TraumaticStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Nancy Kassam-Adams, PhD, Principal investigator, Center for Injury Research & Prevention, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653288
- Sponsor's protocol ID
- 12-009336
- Other IDs
- 1R21HD069832-01A1
- Status last verified
- Feb 2019
- First submitted
- 25 Jul 2012
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26089554
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
- ClinicalTrials.gov ID
- NCT01653288
- Acronym / sponsor ID
- 12-009336
- Conditions
- Stress Disorders, Post Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The University of Queensland
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Coach | Experimental | Behavioral: Coping CoachReceive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. |
| Coping Coach Waitlist Control | Experimental | Behavioral: Coping CoachTreatment 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping CoachCoping 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. | Behavioural | Coping Coach, Coping Coach Waitlist Control |
Primary outcome
Feasibility of the Coping Coach Online Intervention
Time frame: 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
Time frame: 6 weeks
Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
2 secondary outcomes
a Preliminary Assessment of the Efficacy of the Intervention
Time frame: 6 weeks
a Preliminary Assessment of the Efficacy of the Intervention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26089554Kassam-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Kassam-Adams, PhD principal investigator
Center for Injury Research & Prevention, Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Coach in people with Stress Disorders, Post Traumatic, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Coping Coach Online Intervention (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.