Intervention Media to Prevent Adolescent Cyber-conflict Through Technology (IMPACT)
Primary Purpose
Cyberbullying
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMPACT Intervention
Control: Enhanced Online Resources (EOR)
Sponsored by
About this trial
This is an interventional prevention trial for Cyberbullying focused on measuring cyber-victimization, mobile application, mhealth, remote intervention
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
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMPACT Intervention
Control Enhanced Online Resources (EOR)
Arm Description
Remote brief video session, introducing basic principles of cognitive behavioral theory and the structure of the mobile application message portion of the intervention. Eight-weeks longitudinal tailored Cognitive Behavioral Therapy (CBT)-based messaging program
1. We will provide a link to an online resource packet with information on bullying and mental health resources.
Outcomes
Primary Outcome Measures
Intervention Acceptability: Enrollment Rate
% of eligible participants who consented and completed enrollment
Intervention Acceptability: Participant Satisfaction
% of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews
Intervention Feasibility: Participant Engagement
% of intervention participants that complete study components including responding to at least one of the daily message queries, and how many requested on-demand support messages
Secondary Outcome Measures
Cyber-victimization and related online behaviors
Change in University of New Hampshire Internet Safety Education Survey (UNH) from enrollment other forms (cyberbullying); investigators selected 5 items from the survey to measure. Items are scored by participants' self-report of online harassment experiences ranging from 0 ("Never") to 4 ("7 or more times"). Possible score range of 0-20, with higher scores indicating greater number of online harassment experiences.
Psychological stress
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Psychological Stress ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most psychological stress.
Positive affect
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Positive Affect ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most positive affect.
Well-being Index
The World Health Organization- Five- Well-Being Index (WHO-5 ) from enrollment other forms (well-being); Five items are scored by participants' self-report of well-being ranging from 0 ("At no time") to 5 ("All of the time"). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Theoretical mechanisms of prosocial behaviors and self-efficacy
Change in Bystander Intervention in Bullying Measures; 5 items from the Bystander Intervention in Bullying Measures and 8 items from the University of New Hampshire Internet Safety Education Survey. Items are scored by participants' self-report of online bystander behavior ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Possible score range of 13-65, with higher scores indicating greater personal responsibility/self-efficacy to intervene when witnessing online harassment experiences (prosocial behavior and self-efficacy).
Full Information
NCT ID
NCT04259216
First Posted
January 30, 2020
Last Updated
September 20, 2021
Sponsor
Rhode Island Hospital
Collaborators
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04259216
Brief Title
Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
Acronym
IMPACT
Official Title
Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
May 3, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyberbullying
Keywords
cyber-victimization, mobile application, mhealth, remote intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMPACT Intervention
Arm Type
Experimental
Arm Description
Remote brief video session, introducing basic principles of cognitive behavioral theory and the structure of the mobile application message portion of the intervention.
Eight-weeks longitudinal tailored Cognitive Behavioral Therapy (CBT)-based messaging program
Arm Title
Control Enhanced Online Resources (EOR)
Arm Type
Active Comparator
Arm Description
1. We will provide a link to an online resource packet with information on bullying and mental health resources.
Intervention Type
Behavioral
Intervention Name(s)
IMPACT Intervention
Intervention Description
Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.
Intervention Type
Other
Intervention Name(s)
Control: Enhanced Online Resources (EOR)
Intervention Description
EOR group participants will receive standardized information on cyberbullying.
Primary Outcome Measure Information:
Title
Intervention Acceptability: Enrollment Rate
Description
% of eligible participants who consented and completed enrollment
Time Frame
Baseline
Title
Intervention Acceptability: Participant Satisfaction
Description
% of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews
Time Frame
8 week post-enrollment
Title
Intervention Feasibility: Participant Engagement
Description
% of intervention participants that complete study components including responding to at least one of the daily message queries, and how many requested on-demand support messages
Time Frame
Baseline to 8 weeks post-enrollment (close of intervention)
Secondary Outcome Measure Information:
Title
Cyber-victimization and related online behaviors
Description
Change in University of New Hampshire Internet Safety Education Survey (UNH) from enrollment other forms (cyberbullying); investigators selected 5 items from the survey to measure. Items are scored by participants' self-report of online harassment experiences ranging from 0 ("Never") to 4 ("7 or more times"). Possible score range of 0-20, with higher scores indicating greater number of online harassment experiences.
Time Frame
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Title
Psychological stress
Description
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Psychological Stress ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most psychological stress.
Time Frame
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Title
Positive affect
Description
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Positive Affect ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most positive affect.
Time Frame
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Title
Well-being Index
Description
The World Health Organization- Five- Well-Being Index (WHO-5 ) from enrollment other forms (well-being); Five items are scored by participants' self-report of well-being ranging from 0 ("At no time") to 5 ("All of the time"). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Time Frame
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Title
Theoretical mechanisms of prosocial behaviors and self-efficacy
Description
Change in Bystander Intervention in Bullying Measures; 5 items from the Bystander Intervention in Bullying Measures and 8 items from the University of New Hampshire Internet Safety Education Survey. Items are scored by participants' self-report of online bystander behavior ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Possible score range of 13-65, with higher scores indicating greater personal responsibility/self-efficacy to intervene when witnessing online harassment experiences (prosocial behavior and self-efficacy).
Time Frame
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Ranney, MD MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34524103
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.
Results Reference
derived
Learn more about this trial
Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
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