Clinical trial NCT03467009: Bullying Prevention Intervention for Adolescent Primary Care Patients
Official title: Bullying Prevention Intervention for Adolescent Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyberbullying
Keywords: cyber-victimization
text message
mhealth
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-03-15
Enrollment: 77
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Intervention Acceptability: Enrollment Rate
timeFrame: Enrollment
measure: Intervention Acceptability: Change in Follow Up Rate from 8 weeks post-enrollment to 16 weeks post-enrollment
timeFrame: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
measure: Intervention Acceptability: Participant Satisfaction
timeFrame: 8 weeks post-enrollment (close of intervention)
measure: Intervention Feasibility: Participant Engagement
timeFrame: Enrollment to 8 weeks post-enrollment (close of intervention)
Secondary outcomes:
measure: Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
timeFrame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Change in cyber-victimization emotional impact between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
timeFrame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
measure: Change in cyber-victimization related behaviors between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment
timeFrame: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Megan L Ranney, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: