Bullying Prevention Intervention for Adolescent Primary Care Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bullying Prevention Intervention for Adolescent Primary Care Patients

Conditions
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Cyberbullying

Intervention / Treatment
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* Behavioral: iPACT Intervention
* Other: Control: Enhanced Usual Care (EUC)
* Behavioral: iPACT Intervention- app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPACT Intervention<br>In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention. Eight-week longitudinal tailored CBT-based text-message program. | Behavioral: iPACT Intervention<br>* Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.<br>|
| Active Comparator: Control: Enhanced Usual Care (EUC)<br>The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources. | Other: Control: Enhanced Usual Care (EUC)<br>* EUC group participants will receive standardized information on cyberbullying.<br>|
| Experimental: iPACT Intervention- App<br>In-clinic brief session, introducing basic principles of cognitive behavioral theory and the structure of the message portion of the intervention delivered via app. Eight-week longitudinal tailored CBT-based message program delivered via app. | Behavioral: iPACT Intervention- app<br>* Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability: Enrollment Rate | Enrollment Rate: % of eligible participants who consented and completed enrollment | 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 | 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 | 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. | Enrollment to 8 weeks post-enrollment (close of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyber-victimization, text message, mhealth