NCT01606514

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 6, 2014

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

May 21, 2012

Last Update Submit

October 3, 2014

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (4)

  • Change in adolescent mental health symptoms

    baseline, 4 month followup, and 12 month followup

  • Change in parent mental health symptoms

    baseline, 4 month followup, 12 month followup

  • Change in parent-child conflict

    baseline, 4 month followup, 12 month followup

  • Change in parent-child relationship quality

    baseline, 4 month followup, 12 month followup

Study Arms (3)

Child, Parenting, & Parent Web-Intervention

EXPERIMENTAL

Bounce Back Now Child, Parenting, \& Parent Psychoeducation \& Self-Help Web-Intervention.

Behavioral: Bounce Back Now Website

Child & Parenting Web-Intervention

EXPERIMENTAL

Bounce Back Now Child \& Parenting Psychoeducation and Self-Help Web-Intervention.

Behavioral: Bounce Back Now Website

Child & Parent Web-based Assessment

NO INTERVENTION

Bounce Back Now Web-Based Symptom Assessment

Interventions

Bounce Back Now WebsiteBEHAVIORAL

Bounce Back Now is a web-based psychoeducation and self-help website

Child & Parenting Web-InterventionChild, Parenting, & Parent Web-Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26299292DERIVED

Study Officials

  • Kenneth J Ruggiero, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

December 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

October 6, 2014

Record last verified: 2012-08