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

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ClinicalTrials.gov Identifier: NCT01653288
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Queensland
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE July 31, 2012
Results First Submitted Date  ICMJE February 14, 2018
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Feasibility of the Coping Coach Online Intervention [ Time Frame: 6 weeks ]
    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.
  • Mean Time Spent Using the Intervention [ Time Frame: 6 weeks ]
    Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Feasibility of the Coping Coach Online Intervention [ Time Frame: 6 weeks ]
Feasibility of intervention over 6 weeks of use. Measures include: feedback from families (quantitative satisfaction ratings, open-ended comments), as well as automated monitoring data regarding the use of the web-based intervention (i.e. proportion of children who log in at least once, proportion of children who complete all intervention activities, mean number of log-ins, mean time spent using the intervention, mean number of activities completed).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • a Preliminary Assessment of the Efficacy of the Intervention [ Time Frame: 6 weeks ]
    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.
  • a Preliminary Assessment of the Efficacy of the Intervention [ Time Frame: 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
  • a Preliminary Assessment of the Efficacy of the Intervention [ Time Frame: 6 weeks ]
    We will examine differences between waitlist control and intervention conditions in proximal outcomes (trauma-related appraisals and coping strategies) and child health outcomes (PTSS, HRQOL) at a 6 week follow-up assessment.
  • a Preliminary Assessment of the Efficacy of the Intervention [ Time Frame: 12 weeks ]
    We will examine differences between waitlist control and intervention conditions in proximal outcomes (trauma-related appraisals and coping strategies) and child health outcomes (PTSS, HRQOL) at a 12 week follow-up assessment.
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2019)
Preliminary Assessment of Efficacy of Later Use of the Intervention [ Time Frame: 18 weeks ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: July 30, 2012)
Preliminary Assessment of Efficacy of Later Use of the Intervention [ Time Frame: 18 weeks ]
We will examine differences between 12 wk and 18 wk scores for the waitlist control condition in proximal outcomes (trauma-related appraisals and coping strategies) and child health outcomes (PTSS, HRQOL) at an 18 week follow-up assessment. (Waitlist group will have access to the web-based intervention as of 12 wk follow-up.)
 
Descriptive Information
Brief Title  ICMJE A Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Official Title  ICMJE A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Stress Disorders, Post Traumatic
Intervention  ICMJE Behavioral: Coping Coach
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.
Study Arms  ICMJE
  • Experimental: Coping Coach
    Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
    Intervention: Behavioral: Coping Coach
  • Experimental: Coping Coach Waitlist Control
    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.
    Intervention: Behavioral: Coping Coach
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2019)
72
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2012)
70
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01653288
Other Study ID Numbers  ICMJE 12-009336
1R21HD069832-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The University of Queensland
Investigators  ICMJE
Principal Investigator: Nancy Kassam-Adams, PhD Center for Injury Research & Prevention, Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP