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Bullying Prevention Intervention for Adolescent Primary Care Patients (iPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467009
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Cyberbullying Behavioral: iPACT Intervention Other: Control: Enhanced Usual Care (EUC) Behavioral: iPACT Intervention- app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: iPACT Intervention
  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
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
  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 message secondary prevention intervention delivered via app.




Primary Outcome Measures :
  1. Intervention Acceptability: Enrollment Rate [ Time Frame: Enrollment ]
    Enrollment Rate: % of eligible participants who consented and completed enrollment

  2. 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

  3. Intervention Acceptability: Participant Satisfaction [ Time Frame: 8 weeks post-enrollment (close of intervention) ]
    Text Customer Satisfaction Questions

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Megan L Ranney, MD MPH Rhode Island Hospital
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03467009    
Other Study ID Numbers: R21HD088739 ( U.S. NIH Grant/Contract )
R21HD088739 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhode Island Hospital:
cyber-victimization
text message
mhealth
Additional relevant MeSH terms:
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Bullying
Cyberbullying
Aggression
Behavioral Symptoms