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Clinical Trials/NCT03467009
NCT03467009
Completed
N/A

Bullying Prevention Intervention for Adolescent Primary Care Patients

Rhode Island Hospital1 site in 1 country77 target enrollmentMarch 6, 2018
ConditionsCyberbullying

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cyberbullying
Sponsor
Rhode Island Hospital
Enrollment
77
Locations
1
Primary Endpoint
Intervention Acceptability: Enrollment Rate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2018
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment(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(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(Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment)

Study Sites (1)

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