Web-based Intervention for Disaster-Affected Youth and Families

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01606514
First received: May 21, 2012
Last updated: September 5, 2013
Last verified: August 2012
  Purpose

A single disaster, terrorist attack, or other large-scale incident can adversely affect thousands of youth and families. Immediate consequences may include unmet basic needs and high economic burden, particularly among underserved populations. Disasters also can dramatically affect family roles and relationships over time (e.g., family routines, marital stress, parent-child interactions). Whereas most youth are resilient in the aftermath of disasters (i.e., do not develop serious mental health or health-risk problems), the prevalence of various problems of public health significance (e.g., PTSD, depression, substance abuse) clearly increases in this population. This underscores the need for effective, widely accessible, culturally-appropriate and cost-efficient interventions that foster resilience or rapid recovery relative to the health effects of disasters. Yet, few evidence-informed resources are available to youth and families to facilitate post-disaster resilience and recovery. Primary aims of this project are: (a) to develop a Web-based intervention for disaster-affected adolescents and parents targeting prevalent health-related correlates of disasters (i.e., development phase), (b) to conduct a randomized controlled population-based study to examine feasibility and preliminary efficacy of the intervention (i.e., randomized controlled trial [RCT] phase) and cultural relevance (i.e., perceived applicability of the intervention to one's cultural group), and (c) to refine the intervention based on RCT-phase data.


Condition Intervention
Mental Health Wellness 1
Behavioral: Bounce Back Now Website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Web-based Intervention for Disaster-Affected Youth and Families

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change in adolescent mental health symptoms [ Time Frame: baseline, 4 month followup, and 12 month followup ] [ Designated as safety issue: No ]
  • Change in parent mental health symptoms [ Time Frame: baseline, 4 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Change in parent-child conflict [ Time Frame: baseline, 4 month followup, 12 month followup ] [ Designated as safety issue: No ]
  • Change in parent-child relationship quality [ Time Frame: baseline, 4 month followup, 12 month followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Child, Parenting, & Parent Web-Intervention
Bounce Back Now Child, Parenting, & Parent Psychoeducation & Self-Help Web-Intervention.
Behavioral: Bounce Back Now Website
Bounce Back Now is a web-based psychoeducation and self-help website
Experimental: Child & Parenting Web-Intervention
Bounce Back Now Child & Parenting Psychoeducation and Self-Help Web-Intervention.
Behavioral: Bounce Back Now Website
Bounce Back Now is a web-based psychoeducation and self-help website
No Intervention: Child & Parent Web-based Assessment
Bounce Back Now Web-Based Symptom Assessment

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adolescent between the ages of 12-17 and primary caregiver,
  • residence in study identified location(s) at time of disaster,
  • home internet connectivity

Exclusion Criteria:

  • adolescent's primary caregiver not available,
  • no adolescents in home,
  • not residing in location at time of disaster,
  • poor or no internet connectivity
  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: NCT01606514

Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kenneth J Ruggiero, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01606514     History of Changes
Other Study ID Numbers: 1R01 MH081056-01A1, 1R01MH081056-01A1
Study First Received: May 21, 2012
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on July 24, 2014