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Bullying Prevention Intervention for Adolescent Primary Care Patients (iPACT)

Primary Purpose

Cyberbullying

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPACT Intervention
Control: Enhanced Usual Care (EUC)
iPACT Intervention- app
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cyberbullying focused on measuring cyber-victimization, text message, mhealth

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

iPACT Intervention

Control: Enhanced Usual Care (EUC)

iPACT Intervention- App

Arm Description

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.

The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources.

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.

Outcomes

Primary Outcome Measures

Intervention Acceptability: Enrollment Rate
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
Retention Rate: % of consented participants who completed follow up
Intervention Acceptability: Participant Satisfaction
Text Customer Satisfaction Questions
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 27, 2018
Last Updated
November 25, 2019
Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03467009
Brief Title
Bullying Prevention Intervention for Adolescent Primary Care Patients
Acronym
iPACT
Official Title
Bullying Prevention Intervention for Adolescent Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyberbullying
Keywords
cyber-victimization, text message, mhealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPACT Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
The investigators will provide participants with a standard resource sheet with information on bullying and mental health resources.
Arm Title
iPACT Intervention- App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iPACT Intervention
Intervention Description
Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.
Intervention Type
Other
Intervention Name(s)
Control: Enhanced Usual Care (EUC)
Intervention Description
EUC group participants will receive standardized information on cyberbullying.
Intervention Type
Behavioral
Intervention Name(s)
iPACT Intervention- app
Intervention Description
Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.
Primary Outcome Measure Information:
Title
Intervention Acceptability: Enrollment Rate
Description
Enrollment Rate: % of eligible participants who consented and completed enrollment
Time Frame
Enrollment
Title
Intervention Acceptability: Change in Follow Up Rate from 8 weeks post-enrollment to 16 weeks post-enrollment
Description
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)
Title
Intervention Acceptability: Participant Satisfaction
Description
Text Customer Satisfaction Questions
Time Frame
8 weeks post-enrollment (close of intervention)
Title
Intervention Feasibility: Participant Engagement
Description
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)
Secondary Outcome Measure Information:
Title
Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Description
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
Title
Change in cyber-victimization emotional impact between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Description
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
Title
Change in cyber-victimization related behaviors between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan L Ranney, MD MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Bullying Prevention Intervention for Adolescent Primary Care Patients

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