Clinical trial NCT01606514: Web-based Intervention for Disaster-Affected Youth and Families
Official title: Web-based Intervention for Disaster-Affected Youth and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-05-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in adolescent mental health symptoms
timeFrame: baseline, 4 month followup, and 12 month followup
measure: Change in parent mental health symptoms
timeFrame: baseline, 4 month followup, 12 month followup
measure: Change in parent-child conflict
timeFrame: baseline, 4 month followup, 12 month followup
measure: Change in parent-child relationship quality
timeFrame: baseline, 4 month followup, 12 month followup
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Kenneth J Ruggiero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruggiero KJ, Price M, Adams Z, Stauffacher K, McCauley J, Danielson CK, Knapp R, Hanson RF, Davidson TM, Amstadter AB, Carpenter MJ, Saunders BE, Kilpatrick DG, Resnick HS. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2015 Sep;54(9):709-17. doi: 10.1016/j.jaac.2015.07.001. Epub 2015 Jul 11.