- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01606514
Web-based Intervention for Disaster-Affected Youth and Families
October 3, 2014 updated by: Medical University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2000
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Child, Parenting, & Parent Web-Intervention
Bounce Back Now Child, Parenting, & Parent Psychoeducation & Self-Help Web-Intervention.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in adolescent mental health symptoms
Time Frame: baseline, 4 month followup, and 12 month followup
|
baseline, 4 month followup, and 12 month followup
|
|
Change in parent mental health symptoms
Time Frame: baseline, 4 month followup, 12 month followup
|
baseline, 4 month followup, 12 month followup
|
|
Change in parent-child conflict
Time Frame: baseline, 4 month followup, 12 month followup
|
baseline, 4 month followup, 12 month followup
|
|
Change in parent-child relationship quality
Time Frame: baseline, 4 month followup, 12 month followup
|
baseline, 4 month followup, 12 month followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kenneth J Ruggiero, PhD, Medical University of South Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 21, 2012
First Submitted That Met QC Criteria
May 23, 2012
First Posted (Estimate)
May 25, 2012
Study Record Updates
Last Update Posted (Estimate)
October 6, 2014
Last Update Submitted That Met QC Criteria
October 3, 2014
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 1R01MH081056-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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