Web-based Intervention for Disaster-Affected Youth and Families

NCT ID: NCT01606514

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Wellness 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Child, Parenting, & Parent Web-Intervention

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

Group Type EXPERIMENTAL

Bounce Back Now Website

Intervention Type BEHAVIORAL

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

Child & Parenting Web-Intervention

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

Group Type EXPERIMENTAL

Bounce Back Now Website

Intervention Type BEHAVIORAL

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

Child & Parent Web-based Assessment

Bounce Back Now Web-Based Symptom Assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bounce Back Now Website

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth J Ruggiero, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26299292 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01MH081056-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH081056-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

New Haven MOMS Partnership
NCT01665872 COMPLETED NA
Food-Body-Mind Intervention
NCT05964218 COMPLETED PHASE1