Clinical Trials Directory

Trials / Completed

CompletedNCT03467009

Bullying Prevention Intervention for Adolescent Primary Care Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
77 (actual)
Sponsor
Rhode Island Hospital · Academic / Other
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALiPACT InterventionBrief in-person + tailored, daily 8-week text-message secondary prevention intervention.
OTHERControl: Enhanced Usual Care (EUC)EUC group participants will receive standardized information on cyberbullying.
BEHAVIORALiPACT Intervention- appBrief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.

Timeline

Start date
2018-03-06
Primary completion
2019-06-12
Completion
2019-07-31
First posted
2018-03-15
Last updated
2019-11-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03467009. Inclusion in this directory is not an endorsement.