Bullying Prevention Intervention for Adolescent Primary Care Patients (iPACT)

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.

Study Overview

• Status: Completed
• Conditions: Cyberbullying
• Intervention / Treatment: Behavioral: iPACT Intervention; Other: Control: Enhanced Usual Care (EUC); Behavioral: iPACT Intervention- app

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iPACT Intervention; 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; 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; 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; Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Megan L Ranney, MD MPH, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: mhealth; text message; cyber-victimization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Bullying; Cyberbullying
• Other Study ID Numbers: R21HD088739 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No