Intervention Media to Prevent Adolescent Cyber-conflict Through Technology

NCT ID: NCT04259216

Last Updated: 2021-09-21

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Cyberbullying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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IMPACT Intervention

1. Remote brief video session, introducing basic principles of cognitive behavioral theory and the structure of the mobile application message portion of the intervention.
2. Eight-weeks longitudinal tailored Cognitive Behavioral Therapy (CBT)-based messaging program

Group Type EXPERIMENTAL

IMPACT Intervention

Intervention Type BEHAVIORAL

Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.

Control Enhanced Online Resources (EOR)

1\. We will provide a link to an online resource packet with information on bullying and mental health resources.

Group Type ACTIVE_COMPARATOR

Control: Enhanced Online Resources (EOR)

Intervention Type OTHER

EOR group participants will receive standardized information on cyberbullying.

Interventions

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IMPACT Intervention

Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.

Intervention Type BEHAVIORAL

Control: Enhanced Online Resources (EOR)

EOR group participants will receive standardized information on cyberbullying.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan Ranney, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34524103 (View on PubMed)

Other Identifiers

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0000000136/132580194

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0000000136/132580194

Identifier Type: -

Identifier Source: org_study_id

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