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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The University of Queensland
Information provided by (Responsible Party):
Nancy Kassam-Adams, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01653288
First received: July 25, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post Traumatic
Behavioral: Coping Coach
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • feasibility of the Coping Coach online intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • a preliminary assessment of the efficacy of the intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • preliminary assessment of efficacy of later use of the intervention [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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.)


Estimated Enrollment: 70
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Coach
Receive access to Coping Coach online intervention at baseline for use (self-guided, with email reminders) over the next 6 weeks.
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.
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.
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.

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 2 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.

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=70).

The Pilot and RCT combined will help us prepare for rigorous large-scale RCT of Coping Coach.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653288

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
The University of Queensland
Investigators
Principal Investigator: Nancy Kassam-Adams, PhD Center for Injury Research & Prevention, Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Nancy Kassam-Adams, Associate Director Center for Injury Research and Prevention, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01653288     History of Changes
Other Study ID Numbers: 12-009336, 1R21HD069832-01A1
Study First Received: July 25, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014