A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Condition: Stress Disorders, Post Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): Coping Coach
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention