CyberbullyingIMPACTNCT04259216
Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
A study testing IMPACT Intervention in people with Cyberbullying, run by Rhode Island Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Cyberbullying
- What is being tested?
- IMPACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 30 Jun 2020
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- being cognitively unable to take part in the intervention as determined by study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Cyberbullying
- Being tested
- IMPACT Intervention, Control: Enhanced Online Resources (EOR)
- Keywords
- cyber-victimization, mobile application, mhealth, remote intervention
- Medical subject headings
- Cyberbullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT InterventionBehavioural
Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.
Control: Enhanced Online Resources (EOR)Other
EOR group participants will receive standardized information on cyberbullying.
| Study group | Role | What they receive |
|---|---|---|
| IMPACT Intervention | Experimental | 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 Receives: Behavioral: IMPACT Intervention |
| Control Enhanced Online Resources (EOR) | Active comparator | 1. We will provide a link to an online resource packet with information on bullying and mental health resources. Receives: Other: Control: Enhanced Online Resources (EOR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability: Enrollment Rate
% of eligible participants who consented and completed enrollment
Measured: Baseline
Intervention Acceptability: Participant Satisfaction
% of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews
Measured: 8 week post-enrollment
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
Measured: Baseline to 8 weeks post-enrollment (close of intervention)
Secondary outcomes (5)
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.
Measured: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
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.
Measured: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
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.
Measured: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
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.
Measured: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
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).
Measured: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start30 Jan 2020
- Primary completion3 May 2020
- Study completion30 Jun 2020
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 CyberbullyingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Megan Ranney, MD MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259216
- Sponsor's protocol ID
- 0000000136/132580194
- Other IDs
- 0000000136/132580194
- Acronym
- IMPACT
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34524103
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Media to Prevent Adolescent Cyber-conflict Through Technology
- ClinicalTrials.gov ID
- NCT04259216
- Acronym / sponsor ID
- IMPACT / 0000000136/132580194
- Conditions
- Cyberbullying
- Keywords
- cyber-victimization, mobile application, mhealth, remote intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 3 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Feb 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPACT Intervention | Experimental | Behavioral: IMPACT Intervention1. 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 |
| Control Enhanced Online Resources (EOR) | Active comparator | Other: Control: Enhanced Online Resources (EOR)1. We will provide a link to an online resource packet with information on bullying and mental health resources. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- being cognitively unable to take part in the intervention as determined by study staff
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 |
|---|---|---|
| IMPACT InterventionBrief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention. | Behavioural | IMPACT Intervention |
| Control: Enhanced Online Resources (EOR)EOR group participants will receive standardized information on cyberbullying. | Other | Control Enhanced Online Resources (EOR) |
Primary outcome
Intervention Acceptability: Enrollment Rate
Time frame: Baseline
% of eligible participants who consented and completed enrollment
Intervention Acceptability: Participant Satisfaction
Time frame: 8 week post-enrollment
% of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews
Intervention Feasibility: Participant Engagement
Time frame: Baseline to 8 weeks post-enrollment (close of intervention)
% 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
5 secondary outcomes
Cyber-victimization and related online behaviors
Time frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Psychological stress
Time frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Positive affect
Time frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Well-being Index
Time frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Theoretical mechanisms of prosocial behaviors and self-efficacy
Time frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
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 21 Sep 2021.
- Derived from this study: PubMed 34524103Kutok 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.
- Individual participant dataSharing planned: No
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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.
Megan Ranney, MD MPH principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT Intervention in people with Cyberbullying, run by Rhode Island Hospital at 1 site in United States.
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 5 inclusion and 1 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Intervention Acceptability: Enrollment Rate (time frame: Baseline). The study lists 3 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 NCT04259216, 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 21 Sep 2021.