A Trial of Coping Coach, a Web-based Preventive Intervention for Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Coping Coach, a Web-based Preventive Intervention for Children

Conditions
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Stress Disorders, Post Traumatic

Intervention / Treatment
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* Behavioral: Coping Coach


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping Coach<br>Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks. | Behavioral: Coping Coach<br>* 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.<br>|
| Experimental: Coping Coach Waitlist Control<br>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. | Behavioral: Coping Coach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks |