Web-based Intervention for Disaster-Affected Youth and Families

Mental Health Wellness 1 Clinical Trial

Official title:

Web-based Intervention for Disaster-Affected Youth and Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606514
• Other study ID #: 1R01MH081056-01A1
• Secondary ID: 1R01MH081056-01A
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: October 3, 2014
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• Bounce Back Now Website
Bounce Back Now is a web-based psychoeducation and self-help website

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in adolescent mental health symptoms		baseline, 4 month followup, and 12 month followup	No
Primary	Change in parent mental health symptoms		baseline, 4 month followup, 12 month followup	No
Primary	Change in parent-child conflict		baseline, 4 month followup, 12 month followup	No
Primary	Change in parent-child relationship quality		baseline, 4 month followup, 12 month followup	No