N/A
N=72
A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Stress Disorders, Post Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT01653288 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Feasibility of the Coping Coach Online Intervention — 35; 19; 1; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coping Coach (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Coping Coach Online Intervention |
35; 19; 1; 9; 19; 15 | — |
| PRIMARY Mean Time Spent Using the Intervention |
52.2; 51.5 | — |
| SECONDARY a Preliminary Assessment of the Efficacy of the Intervention |
39.3; 41.3; 30.6; 31.7; 13.9; 14.6 | — |
| SECONDARY a Preliminary Assessment of the Efficacy of the Intervention |
39.3; 41.3; 30.6; 31.7; 13.9; 14.6 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01653288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.