A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
2 other identifiers
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedFebruary 26, 2019
February 1, 2019
3 years
July 25, 2012
February 14, 2018
February 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
a Preliminary Assessment of the Efficacy of the Intervention
6 weeks
a Preliminary Assessment of the Efficacy of the Intervention
12 weeks
Other Outcomes (1)
Preliminary Assessment of Efficacy of Later Use of the Intervention
18 weeks
Study Arms (2)
Coping Coach
EXPERIMENTALReceive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
Coping Coach Waitlist Control
EXPERIMENTALTreatment 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 26089554DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nancy Kassam-Adams
- Organization
- Children's Hospital of Philadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Kassam-Adams, PhD
Center for Injury Research & Prevention, Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
July 31, 2012
Study Start
March 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 26, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-02