Bullying Prevention Intervention for Adolescent Primary Care Patients (iPACT)
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|ClinicalTrials.gov Identifier: NCT03467009|
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cyberbullying||Behavioral: iPACT Intervention Other: Control: Enhanced Usual Care (EUC) Behavioral: iPACT Intervention- app||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bullying Prevention Intervention for Adolescent Primary Care Patients|
|Actual Study Start Date :||March 6, 2018|
|Actual Primary Completion Date :||June 12, 2019|
|Actual Study Completion Date :||July 31, 2019|
Experimental: iPACT Intervention
Behavioral: iPACT Intervention
Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.
Active Comparator: Control: Enhanced Usual Care (EUC)
The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources.
Other: Control: Enhanced Usual Care (EUC)
EUC group participants will receive standardized information on cyberbullying.
Experimental: iPACT Intervention- App
Behavioral: iPACT Intervention- app
Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.
- 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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467009
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Megan L Ranney, MD MPH||Rhode Island Hospital|