NCT04259216

Brief Summary

The purpose of this randomized pilot trial is to test the feasibility of online recruitment and intervention delivery of the same Intervention to Prevent Cyber-victimization among Adolescents through Text-Messaging (iPACT) intervention content, delivered via mobile app (instead of SMS). This study includes a brief remote introductory session, followed by eight weeks of daily, tailored two-way messages, with an 8-week assessment. If successful, the IMPACT intervention will demonstrate feasibility and acceptability of an easily disseminable intervention to improve wellness and resilience among at-risk youth and their social network.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 21, 2021

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

January 30, 2020

Last Update Submit

September 20, 2021

Conditions

Cyberbullying

Keywords

cyber-victimizationmobile applicationmhealthremote intervention

Outcome Measures

Primary Outcomes (3)

  • Intervention Acceptability: Enrollment Rate

    % of eligible participants who consented and completed enrollment

    Baseline

  • Intervention Acceptability: Participant Satisfaction

    % of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews

    8 week post-enrollment

  • Intervention Feasibility: Participant Engagement

    % of intervention participants that complete study components including responding to at least one of the daily message queries, and how many requested on-demand support messages

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

Secondary Outcomes (5)

  • Cyber-victimization and related online behaviors

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

  • Psychological stress

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

  • Positive affect

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

  • Well-being Index

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

  • Theoretical mechanisms of prosocial behaviors and self-efficacy

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

Study Arms (2)

IMPACT Intervention

EXPERIMENTAL

1. Remote brief video session, introducing basic principles of cognitive behavioral theory and the structure of the mobile application message portion of the intervention. 2. Eight-weeks longitudinal tailored Cognitive Behavioral Therapy (CBT)-based messaging program

Behavioral: IMPACT Intervention

Control Enhanced Online Resources (EOR)

ACTIVE COMPARATOR

1\. We will provide a link to an online resource packet with information on bullying and mental health resources.

Other: Control: Enhanced Online Resources (EOR)

Interventions

IMPACT InterventionBEHAVIORAL

Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.

IMPACT Intervention
Control: Enhanced Online Resources (EOR)OTHER

EOR group participants will receive standardized information on cyberbullying.

Control Enhanced Online Resources (EOR)

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • reside in the US
  • being English-speaking
  • having a English-speaking parent
  • active Instagram account
  • self-reporting cyber-victimization (defined as endorsing \>1 past-year episode of technology mediated victimization)

You may not qualify if:

  • being cognitively unable to take part in the intervention as determined by study staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Kutok ER, Dunsiger S, Patena JV, Nugent NR, Riese A, Rosen RK, Ranney ML. A Cyberbullying Media-Based Prevention Intervention for Adolescents on Instagram: Pilot Randomized Controlled Trial. JMIR Ment Health. 2021 Sep 15;8(9):e26029. doi: 10.2196/26029.

    PMID: 34524103DERIVED

MeSH Terms

Conditions

Cyberbullying

Condition Hierarchy (Ancestors)

BullyingAggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Study Officials

  • Megan 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

January 30, 2020

First Posted

February 6, 2020

Study Start

January 30, 2020

Primary Completion

May 3, 2020

Study Completion

June 30, 2020

Last Updated

September 21, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)