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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD088739 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPACT Intervention | Experimental |
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| 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. |
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| iPACT Intervention- App | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPACT Intervention | Behavioral | Brief in-person + tailored, daily 8-week text-message secondary prevention intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cyber-victimization between enrollment, 8 weeks post-enrollment, and 16 weeks post-enrollment | Modified version of the University of New Hampshire Internet Safety Education Survey (Jones et al. 2012); investigators selected 5 items from the survey to measure. Items are scored by participants' self-report of online harassment experiences ranging from 0 ("Never") to 4 ("7 or more times"). Possible score range of 0-20, with higher scores indicating greater number of online harassment experiences. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan L Ranney, MD MPH | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D000077224 | Cyberbullying |
| ID | Term |
|---|---|
| D058445 | Bullying |
| D000374 | Aggression |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000071277 |
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| Control: Enhanced Usual Care (EUC) | Other | EUC group participants will receive standardized information on cyberbullying. |
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| iPACT Intervention- app | Behavioral | Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app. |
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| 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 | Modified version of the Cyber-Victimization Emotional Impact Scale (Elipe et al. 2015); investigators selected 7 of the 18 items to measure. Items are scored by participants' self-report of feelings ranging from 0 ("Not at all") to 4 ("Extremely"). Possible score range of 0-28, with higher scores indicating greater degree of emotional impact. | 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 | Comprised of 5 items from the Bystander Intervention in Bullying Measures (Nickerson et al. 2014) and 8 items from the University of New Hampshire Internet Safety Education Survey (Jones et al. 2012). Items are scored by participants' self-report of online bystander behavior ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Possible score range of 13-65, with higher scores indicating greater personal responsibility/self-efficacy to intervene when witnessing online harassment experiences. | Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment |
| Harassment, Non-Sexual |
| D012919 | Social Behavior |