Clinical trial NCT04259216: Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
Official title: Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyberbullying
Keywords: cyber-victimization
mobile application
mhealth
remote intervention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2020-02-06
Enrollment: 79
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* reside in the US
* being English-speaking
* having a English-speaking parent
* active Instagram account
* self-reporting cyber-victimization (defined as endorsing \>1 past-year episode of technology mediated victimization)

Exclusion Criteria:

* being cognitively unable to take part in the intervention as determined by study staff

Primary outcomes:
measure: Intervention Acceptability: Enrollment Rate
timeFrame: Baseline
measure: Intervention Acceptability: Participant Satisfaction
timeFrame: 8 week post-enrollment
measure: Intervention Feasibility: Participant Engagement
timeFrame: Baseline to 8 weeks post-enrollment (close of intervention)
Secondary outcomes:
measure: Cyber-victimization and related online behaviors
timeFrame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Psychological stress
timeFrame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Positive affect
timeFrame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Well-being Index
timeFrame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Theoretical mechanisms of prosocial behaviors and self-efficacy
timeFrame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Megan Ranney, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kutok ER, Dunsiger S, Patena JV, Nugent NR, Riese A, Rosen RK, Ranney ML. A Cyberbullying Media-Based Prevention Intervention for Adolescents on Instagram: Pilot Randomized Controlled Trial. JMIR Ment Health. 2021 Sep 15;8(9):e26029. doi: 10.2196/26029.