Bullying Prevention Intervention for Adolescent Primary Care Patients

NCT03467009 | Completed DMC

• 1 other identifier: R21HD088739
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyberbullying

Keywords

cyber-victimization; text message; mhealth

Outcome Measures

Primary Outcomes (4)

• Intervention Acceptability: Enrollment Rate

  Enrollment Rate: % of eligible participants who consented and completed enrollment

  Enrollment

• Intervention Acceptability: Change in Follow Up Rate from 8 weeks post-enrollment to 16 weeks post-enrollment

  Retention Rate: % of consented participants who completed follow up

  8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)

• Intervention Acceptability: Participant Satisfaction

  Text Customer Satisfaction Questions

  8 weeks post-enrollment (close of intervention)

• Intervention Feasibility: Participant Engagement

  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.

  Enrollment to 8 weeks post-enrollment (close of intervention)

Secondary Outcomes (3)

• 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 Arms (3)

iPACT Intervention

EXPERIMENTAL

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

Control: Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Other: Control: Enhanced Usual Care (EUC)

iPACT Intervention- App

EXPERIMENTAL

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

Interventions

iPACT Intervention BEHAVIORAL

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

iPACT Intervention

Control: Enhanced Usual Care (EUC) OTHER

EUC group participants will receive standardized information on cyberbullying.

Control: Enhanced Usual Care (EUC)

iPACT Intervention- app BEHAVIORAL

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

iPACT Intervention- App

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Cyberbullying

Condition Hierarchy (Ancestors)

Bullying; Aggression; Behavioral Symptoms; Behavior; Harassment, Non-Sexual; Social Behavior

Study Officials

• Megan L Ranney, MD MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 15, 2018
• Study Start: March 6, 2018
• Primary Completion: June 12, 2019
• Study Completion: July 31, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)