An interventional study of iPACT Intervention and Control: Enhanced Usual Care (EUC) in Cyberbullying, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
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.
25 studies on the registry are indexed under Cyberbullying; 8 are open to participants now.
This study's enrollment of 77 is below the median of 150 across 21 interventional studies indexed under Cyberbullying.
Browse Cyberbullying studies →Rhode Island Hospital is the lead sponsor of 192 studies on the registry; 37 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: iPACT Intervention
The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources.
Other: Control: Enhanced Usual Care (EUC)
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.
Behavioral: iPACT Intervention- app
Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.
EUC group participants will receive standardized information on cyberbullying.
Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.
Intervention Acceptability: Enrollment Rate
Enrollment Rate: % of eligible participants who consented and completed enrollment
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Enrollment to 8 weeks post-enrollment (close of intervention)
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.
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
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.
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
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.
Time frame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Jun 2019, 15 months.
Of 19 interventional studies with no phase under Cyberbullying, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's 15 months is above that.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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