Bullying Prevention Intervention for Adolescent Primary Care Patients

NCT ID: NCT03467009

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2019-07-31

Brief Summary

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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

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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

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Cyberbullying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

iPACT Intervention

Intervention Type BEHAVIORAL

Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.

Control: Enhanced Usual Care (EUC)

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

Group Type ACTIVE_COMPARATOR

Control: Enhanced Usual Care (EUC)

Intervention Type OTHER

EUC group participants will receive standardized information on cyberbullying.

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.

Group Type EXPERIMENTAL

iPACT Intervention- app

Intervention Type BEHAVIORAL

Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.

Interventions

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iPACT Intervention

Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.

Intervention Type BEHAVIORAL

Control: Enhanced Usual Care (EUC)

EUC group participants will receive standardized information on cyberbullying.

Intervention Type OTHER

iPACT Intervention- app

Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan L Ranney, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R21HD088739

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21HD088739

Identifier Type: NIH

Identifier Source: org_study_id

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