Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04259216 |
| Other study ID # |
0000000136/132580194 |
| Secondary ID |
0000000136/13258 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2020 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Rhode Island Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this randomized pilot trial is to test the feasibility of online recruitment
and intervention delivery of the same Intervention to Prevent Cyber-victimization among
Adolescents through Text-Messaging (iPACT) intervention content, delivered via mobile app
(instead of SMS). This study includes a brief remote introductory session, followed by eight
weeks of daily, tailored two-way messages, with an 8-week assessment. If successful, the
IMPACT intervention will demonstrate feasibility and acceptability of an easily disseminable
intervention to improve wellness and resilience among at-risk youth and their social network.
Description:
Cyber-bullying, defined as intentional harm of others through computers, cellphones, and
other electronic devices, is increasingly common. Approximately one quarter of American
adolescents report that they have been cyber-victims in the past year (with rates ranging
from 6-72%, depending on the study). Being a victim of cyber-bullying is strongly associated
with multiple negative consequences. Cyber-victimization predicts depressive symptoms and
suicidality; it correlates with Post Traumatic Stress Disorder (PTSD) symptoms, alcohol and
other drug use, physical peer violence, and dating violence. Emotional regulation skills and
positive social supports may be protective. Development of an acceptable, effective, and
potentially disseminable secondary prevention tool, to decrease both the frequency and
consequences of cyber-victimization, is therefore of high public health importance.
Effective, acceptable, and easily disseminable secondary prevention tools are needed to
improve adolescent resilience and reduce the negative effects of cybervictimization.
Ninety-five percent of adolescents have access to a smartphone. Our team recently conducted
an NICHD-funded pilot of an in-person brief intervention + automated 8-week interactive
text-message program ("iPACT"), to reduce cyber-victimization among youth recruited in a
pediatric clinic. Pilot testing of iPACT showed high acceptability (89% responses to daily
messages), and preliminary signals of efficacy (e.g. improved use of bystander behaviors).
However, our team identified two elements for improvement. First, the in-person brief
intervention was difficult to deliver during a clinic visit due to patients' time
limitations. Second, our and others' work suggests that at-risk youth are more commonly
witnesses of cyber-victimization, than victims themselves, and therefore need greater content
focused on bystander intervention. Third, at-risk youth may be more easily identified online
than in person.
Participants will be identified through targeted Instagram advertisements. If eligible,
participants will complete an online assent form followed by a series of comprehensive
questions to assess for capacity to assent. Participants will complete a baseline assessment
and will be randomized to experimental (IMPACT, n=40) or connection to Enhance Online
Resources (EOR, n=40).
This study will pilot an enhanced intervention, "IMPACT" is a two-part remotely-delivered
intervention for youth reporting online victimization, derived from iPACT's existing
structure, to promote pro-social behavior and enhance wellness among at-risk adolescents. We
will deliver a brief, computer-guided discussion (an adaptation of iPACT's in-person
intervention) remotely via video chat; and deliver 8 weeks of automated, enhanced message
content that helps participants identify, intervene in, and effectively reduce the impact of
witnessed or experienced cyberbullying. EOR group participants will receive standardized
information on cyberbullying.
Participants will complete assessments at baseline, 8 weeks, and 16 week to measure
cyberbullying, peer violence, and cognitive/behavioral skill sets. At the 8 week follow-up,
we will assess for efficacy, acceptability, usability, and feasibility through standardized
qualitative and quantitative measures.
