Mental Health Wellness 1NCT01606514
Web-based Intervention for Disaster-Affected Youth and Families
A study testing Bounce Back Now Website in people with Mental Health Wellness 1, run by Medical University of South Carolina.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Bounce Back Now Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adolescent between the ages of 12-17 and primary caregiver,
- residence in study identified location(s) at time of disaster,
- home internet connectivity
Who cannot join
- adolescent's primary caregiver not available,
- no adolescents in home,
- not residing in location at time of disaster,
- poor or no internet connectivity
About this study
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Bounce Back Now Website
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bounce Back Now WebsiteBehavioural
Bounce Back Now is a web-based psychoeducation and self-help website
| Study group | Role | What they receive |
|---|---|---|
| Child, Parenting, & Parent Web-Intervention | Experimental | Bounce Back Now Child, Parenting, \& Parent Psychoeducation \& Self-Help Web-Intervention. Receives: Behavioral: Bounce Back Now Website |
| Child & Parenting Web-Intervention | Experimental | Bounce Back Now Child \& Parenting Psychoeducation and Self-Help Web-Intervention. Receives: Behavioral: Bounce Back Now Website |
| Child & Parent Web-based Assessment | No intervention | Bounce Back Now Web-Based Symptom Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent mental health symptoms
Measured: baseline, 4 month followup, and 12 month followup
Change in parent mental health symptoms
Measured: baseline, 4 month followup, 12 month followup
Change in parent-child conflict
Measured: baseline, 4 month followup, 12 month followup
Change in parent-child relationship quality
Measured: baseline, 4 month followup, 12 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kenneth J Ruggiero, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606514
- Sponsor's protocol ID
- 1R01MH081056-01A1
- Other IDs
- 1R01MH081056-01A1
- Status last verified
- Aug 2012
- First submitted
- 21 May 2012
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26299292
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Intervention for Disaster-Affected Youth and Families
- ClinicalTrials.gov ID
- NCT01606514
- Acronym / sponsor ID
- 1R01MH081056-01A1
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child, Parenting, & Parent Web-Intervention | Experimental | Behavioral: Bounce Back Now WebsiteBounce Back Now Child, Parenting, \& Parent Psychoeducation \& Self-Help Web-Intervention. |
| Child & Parenting Web-Intervention | Experimental | Behavioral: Bounce Back Now WebsiteBounce Back Now Child \& Parenting Psychoeducation and Self-Help Web-Intervention. |
| Child & Parent Web-based Assessment | No intervention | –Bounce Back Now Web-Based Symptom Assessment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- adolescent between the ages of 12-17 and primary caregiver,
- residence in study identified location(s) at time of disaster,
- home internet connectivity
Key exclusion criteria (4 listed)
- adolescent's primary caregiver not available,
- no adolescents in home,
- not residing in location at time of disaster,
- poor or no internet connectivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bounce Back Now WebsiteBounce Back Now is a web-based psychoeducation and self-help website | Behavioural | Child & Parenting Web-Intervention, Child, Parenting, & Parent Web-Intervention |
Primary outcome
Change in adolescent mental health symptoms
Time frame: baseline, 4 month followup, and 12 month followup
Change in parent mental health symptoms
Time frame: baseline, 4 month followup, 12 month followup
Change in parent-child conflict
Time frame: baseline, 4 month followup, 12 month followup
Change in parent-child relationship quality
Time frame: baseline, 4 month followup, 12 month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Derived from this study: PubMed 26299292Ruggiero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J Ruggiero, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Bounce Back Now Website in people with Mental Health Wellness 1, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adolescent mental health symptoms (time frame: baseline, 4 month followup, and 12 month followup). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.