Clinical trial NCT01653288: A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Official title: A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The University of Queensland
First posted: 2012-07-31
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Feasibility of the Coping Coach Online Intervention
timeFrame: 6 weeks
measure: Mean Time Spent Using the Intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: a Preliminary Assessment of the Efficacy of the Intervention
timeFrame: 6 weeks
measure: a Preliminary Assessment of the Efficacy of the Intervention
timeFrame: 12 weeks
Other outcomes:
measure: Preliminary Assessment of Efficacy of Later Use of the Intervention
timeFrame: 18 weeks
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Center for Injury Research & Prevention, Children's Hospital of Philadelphia
name: Nancy Kassam-Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.