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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT04259216
Study groupRoleWhat they receive
IMPACT InterventionExperimental1. 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 comparator1. 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.

  1. Intervention Acceptability: Enrollment Rate

    % of eligible participants who consented and completed enrollment

    Measured: Baseline

  2. Intervention Acceptability: Participant Satisfaction

    % of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews

    Measured: 8 week post-enrollment

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted6 Feb 2020
  2. Study start30 Jan 2020
  3. Primary completion3 May 2020
  4. Study completion30 Jun 2020

Resources

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)
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

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.

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