CyberbullyingiPACTNCT03467009
Bullying Prevention Intervention for Adolescent Primary Care Patients
A study testing iPACT Intervention and iPACT Intervention- app in people with Cyberbullying, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this randomized controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iPACT" (intervention to Prevent Adolescent Cyber-victimization with Text messages), a brief in-clinic introductory session + longitudinal automated text-message-based… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Cyberbullying
- What is being tested?
- iPACT Intervention and iPACT Intervention- app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 31 Jul 2019
- 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
- presenting to Hasbro Children's pediatric clinic
- being mentally and physically able to assent
- being English-speaking
- having a consentable parent present
- self-reporting cyber-victimization (defined as endorsing >1 past-year episode of technology-mediated victimization)
Who cannot join
- being cognitively or emotionally unable to take part in the intervention as determined by the pediatric attending clinician
- suspected by clinical staff of being a victim of child abuse
- currently incarcerated or under police custody
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 controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iPACT" (intervention to Prevent Adolescent Cyber-victimization with Text messages), a brief in-clinic introductory session + longitudinal automated text-message-based secondary prevention program for adolescents with a history of past-year cyber-victimization presenting to a pediatric clinic for well-child visits.
Read the detailed description
Cyber-victimization predicts depressive symptoms and suicidality; it correlates with PTSD symptoms, alcohol and other drug use, physical peer violence, and dating violence.
Almost 80% of adolescents have a well-child visit with their pediatrician each year. Pediatricians recognize this visit as an important opportunity for behavioral screening, interventions, and referrals, but they currently lack cyber-victimization interventions that are feasible and effective in the clinical setting. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.
The purpose of this study is to test the feasibility and acceptability of a novel text-message-augmented secondary prevention intervention, "iPACT." Drawing on effective cognitive behavioral therapy (CBT) and motivational interviewing (MI) depression and violence prevention interventions, a brief in-clinic session will introduce basic cognitive and behavioral strategies. Following their clinic visit, eight weeks of tailored CBT-informed daily text messages will be sent, to enhance skills and remind participants of self-determined goals.
Participants will be identified in the course of usual clinical care. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to experimental (iPACT, n=25) or enhanced usual care (EUC, n=25) care, using stratified block randomization.
iPACT group participants will participate in a brief, structured in-clinic introduction on CBT and the iPACT program, followed by 8 weeks of tailored, two-way, CBT-and MI-informed automated text messages (short message service, SMS). EUC group participants will receive standardized information on cyberbullying. The current standard of care for these patients is no care: no cyber-victimization screening assessment protocols are currently used in our clinic. Both iPACT and EUC conditions therefore exceed current levels of care.
At baseline, 8 week follow-up, and 16 week follow-up, participants will complete assessments on cyberbullying, peer violence, and cognitive/behavioral skill-sets. At the 8-week follow-up, standardized qualitative and quantitative process measures will be administered to assess efficacy, acceptability, usability, and feasibility.
- Conditions
- Cyberbullying
- Being tested
- iPACT Intervention, Control: Enhanced Usual Care (EUC), iPACT Intervention- app
- Keywords
- cyber-victimization, text message, mhealth
- Medical subject headings
- Cyberbullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPACT InterventionBehavioural
Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.
Control: Enhanced Usual Care (EUC)Other
EUC group participants will receive standardized information on cyberbullying.
iPACT Intervention- appBehavioural
Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.
| Study group | Role | What they receive |
|---|---|---|
| iPACT Intervention | Experimental | 1. In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention.
2. Eight-week longitudinal tailored CBT-based text-message program. Receives: Behavioral: iPACT Intervention |
| Control: Enhanced Usual Care (EUC) | Active comparator | The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources. Receives: Other: Control: Enhanced Usual Care (EUC) |
| iPACT Intervention- App | Experimental | 1. In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the message portion of the intervention delivered via app.
2. Eight-week longitudinal tailored CBT-based message program delivered via app. Receives: Behavioral: iPACT Intervention- app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability: Enrollment Rate
Enrollment Rate: % of eligible participants who consented and completed enrollment
Measured: Enrollment
Intervention Acceptability: Change in Follow Up Rate from 8 weeks post-enrollment to 16 weeks post-enrollment
Retention Rate: % of consented participants who completed follow up
Measured: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Intervention Acceptability: Participant Satisfaction
Text Customer Satisfaction Questions
Measured: 8 weeks post-enrollment (close of intervention)
Intervention Feasibility: Participant Engagement
Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.
Measured: Enrollment to 8 weeks post-enrollment (close of intervention)
Secondary outcomes (3)
Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Modified version of the University of New Hampshire Internet Safety Education Survey (Jones et al. 2012); 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: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in cyber-victimization emotional impact between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Modified version of the Cyber-Victimization Emotional Impact Scale (Elipe et al. 2015); investigators selected 7 of the 18 items to measure. Items are scored by participants' self-report of feelings ranging from 0 ("Not at all") to 4 ("Extremely"). Possible score range of 0-28, with higher scores indicating greater degree of emotional impact.
Measured: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in cyber-victimization related behaviors between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Comprised of 5 items from the Bystander Intervention in Bullying Measures (Nickerson et al. 2014) and 8 items from the University of New Hampshire Internet Safety Education Survey (Jones et al. 2012). 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.
Measured: Enrollment, 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 posted15 Mar 2018
- Study start6 Mar 2018
- Primary completion12 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Megan L Ranney, MD MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467009
- Sponsor's protocol ID
- R21HD088739
- Other IDs
- R21HD088739
- Acronym
- iPACT
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bullying Prevention Intervention for Adolescent Primary Care Patients
- ClinicalTrials.gov ID
- NCT03467009
- Acronym / sponsor ID
- iPACT / R21HD088739
- Conditions
- Cyberbullying
- Keywords
- cyber-victimization, text message, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Mar 2018 (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 controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iPACT" (intervention to Prevent Adolescent Cyber-victimization with Text messages), a brief in-clinic introductory session + longitudinal automated text-message-based secondary prevention program for adolescents with a history of past-year cyber-victimization presenting to a pediatric clinic for well-child visits.
Detailed description
Cyber-victimization predicts depressive symptoms and suicidality; it correlates with PTSD symptoms, alcohol and other drug use, physical peer violence, and dating violence.
Almost 80% of adolescents have a well-child visit with their pediatrician each year. Pediatricians recognize this visit as an important opportunity for behavioral screening, interventions, and referrals, but they currently lack cyber-victimization interventions that are feasible and effective in the clinical setting. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.
The purpose of this study is to test the feasibility and acceptability of a novel text-message-augmented secondary prevention intervention, "iPACT." Drawing on effective cognitive behavioral therapy (CBT) and motivational interviewing (MI) depression and violence prevention interventions, a brief in-clinic session will introduce basic cognitive and behavioral strategies. Following their clinic visit, eight weeks of tailored CBT-informed daily text messages will be sent, to enhance skills and remind participants of self-determined goals.
Participants will be identified in the course of usual clinical care. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to experimental (iPACT, n=25) or enhanced usual care (EUC, n=25) care, using stratified block randomization.
iPACT group participants will participate in a brief, structured in-clinic introduction on CBT and the iPACT program, followed by 8 weeks of tailored, two-way, CBT-and MI-informed automated text messages (short message service, SMS). EUC group participants will receive standardized information on cyberbullying. The current standard of care for these patients is no care: no cyber-victimization screening assessment protocols are currently used in our clinic. Both iPACT and EUC conditions therefore exceed current levels of care.
At baseline, 8 week follow-up, and 16 week follow-up, participants will complete assessments on cyberbullying, peer violence, and cognitive/behavioral skill-sets. At the 8-week follow-up, standardized qualitative and quantitative process measures will be administered to assess efficacy, acceptability, usability, and feasibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iPACT Intervention | Experimental | Behavioral: iPACT Intervention1. In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention. 2. Eight-week longitudinal tailored CBT-based text-message program. |
| Control: Enhanced Usual Care (EUC) | Active comparator | Other: Control: Enhanced Usual Care (EUC)The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources. |
| iPACT Intervention- App | Experimental | Behavioral: iPACT Intervention- app1. In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the message portion of the intervention delivered via app. 2. Eight-week longitudinal tailored CBT-based message program delivered via app. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- presenting to Hasbro Children's pediatric clinic
- being mentally and physically able to assent
- being English-speaking
- having a consentable parent present
- self-reporting cyber-victimization (defined as endorsing >1 past-year episode of technology-mediated victimization)
Key exclusion criteria (3 listed)
- being cognitively or emotionally unable to take part in the intervention as determined by the pediatric attending clinician
- suspected by clinical staff of being a victim of child abuse
- currently incarcerated or under police custody
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 |
|---|---|---|
| iPACT InterventionBrief in-person + tailored, daily 8-week text-message secondary prevention intervention. | Behavioural | iPACT Intervention |
| Control: Enhanced Usual Care (EUC)EUC group participants will receive standardized information on cyberbullying. | Other | Control: Enhanced Usual Care (EUC) |
| iPACT Intervention- appBrief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app. | Behavioural | iPACT Intervention- App |
Primary outcome
Intervention Acceptability: Enrollment Rate
Time frame: Enrollment
Enrollment Rate: % of eligible participants who consented and completed enrollment
Intervention Acceptability: Change in Follow Up Rate from 8 weeks post-enrollment to 16 weeks post-enrollment
Time frame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Retention Rate: % of consented participants who completed follow up
Intervention Acceptability: Participant Satisfaction
Time frame: 8 weeks post-enrollment (close of intervention)
Text Customer Satisfaction Questions
Intervention Feasibility: Participant Engagement
Time frame: Enrollment to 8 weeks post-enrollment (close of intervention)
Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.
3 secondary outcomes
Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in cyber-victimization emotional impact between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in cyber-victimization related behaviors between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Time frame: Enrollment, 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 26 Nov 2019.
- 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 L 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 iPACT Intervention and iPACT Intervention- app 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 3 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 26 Nov 2019. 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: Enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2019.